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First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors (IMGN853-0401)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01609556
Recruitment Status : Completed
First Posted : June 1, 2012
Results First Posted : February 17, 2021
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tumors
Intervention Drug: Mirvetuximab soravtansine
Enrollment 206
Recruitment Details A total of 206 participants were enrolled in this study, of whom 69 participants (44 to receive Schedule A and 25 to receive Schedule B treatment) were entered in dose-escalation phase and 137 participants (113 with epithelial ovarian cancer [EOC] and 24 with endometrial cancer [EC]) were entered in dose-expansion phase. Doses calculated initially based on participant's total body weight (TBW); then from protocol amendment 5 onwards, calculated based on adjusted ideal body weight (AIBW).
Pre-assignment Details Dose expansion Cohort 4 was planned to enroll relapsed/refractory non-small cell lung cancer (NSCLC) adenocarcinoma or bronchoalveolar carcinoma (BAC) but no participants were enrolled due to a company decision to focus on endometrial and ovarian carcinoma for the initial investigation.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description Participants received mirvetuximab soravtansine 0.15 milligrams (mg)/kilogram (kg) intravenous (IV) infusion on Day 1 of every 21-day (every 3 weeks [Q3W]) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (maximum tolerated dose [MTD]) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants with folate receptor 1 (FOLR1)-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Period Title: Dose Escalation: Maximum 101.3 Weeks
Started 2 1 1 1 9 18 7 5 5 4 9 7 0 0 0 0
Received at Least 1 Dose of Study Drug 2 1 1 1 9 18 7 5 5 4 9 7 0 0 0 0
Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 2 1 1 1 9 18 7 5 5 4 9 7 0 0 0 0
Reason Not Completed
Adverse Event             0             0             0             0             1             0             0             1             1             0             1             1             0             0             0             0
Disease Progression             0             1             1             1             8             13             5             4             3             3             6             3             0             0             0             0
Clinical Progression             0             0             0             0             0             2             2             0             0             1             1             2             0             0             0             0
Began New Anticancer Therapy             0             0             0             0             0             1             0             0             0             0             0             1             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0
Investigator Decision             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0
Death             2             0             0             0             0             1             0             0             0             0             1             0             0             0             0             0
Period Title: Dose Expansion: Maximum 124 Weeks
Started 0 0 0 0 0 0 0 0 0 0 0 0 46 24 27 40
Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 46 24 27 40
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             0             0             0             0             4             2             2             2
Disease Progression             0             0             0             0             0             0             0             0             0             0             0             0             32             13             20             27
Clinical Progression             0             0             0             0             0             0             0             0             0             0             0             0             3             3             3             2
Began New Anticancer Therapy             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             0             0             1             4             2             5
Investigator Decision             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1
Death             0             0             0             0             0             0             0             0             0             0             0             0             4             2             0             3
Other Than Specified             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W) Total
Hide Arm/Group Description Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Total of all reporting groups
Overall Number of Baseline Participants 2 1 1 1 9 18 7 5 5 4 9 7 46 24 27 40 206
Hide Baseline Analysis Population Description
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 1 participants 1 participants 9 participants 18 participants 7 participants 5 participants 5 participants 4 participants 9 participants 7 participants 46 participants 24 participants 27 participants 40 participants 206 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
1
 100.0%
0
   0.0%
1
 100.0%
6
  66.7%
11
  61.1%
4
  57.1%
3
  60.0%
2
  40.0%
2
  50.0%
5
  55.6%
5
  71.4%
25
  54.3%
10
  41.7%
17
  63.0%
30
  75.0%
122
  59.2%
>=65 years
2
 100.0%
0
   0.0%
1
 100.0%
0
   0.0%
3
  33.3%
7
  38.9%
3
  42.9%
2
  40.0%
3
  60.0%
2
  50.0%
4
  44.4%
2
  28.6%
21
  45.7%
14
  58.3%
10
  37.0%
10
  25.0%
84
  40.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 1 participants 1 participants 9 participants 18 participants 7 participants 5 participants 5 participants 4 participants 9 participants 7 participants 46 participants 24 participants 27 participants 40 participants 206 participants
Female
2
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
9
 100.0%
16
  88.9%
5
  71.4%
4
  80.0%
4
  80.0%
4
 100.0%
9
 100.0%
7
 100.0%
46
 100.0%
24
 100.0%
27
 100.0%
40
 100.0%
200
  97.1%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  11.1%
2
  28.6%
1
  20.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6
   2.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 1 participants 1 participants 9 participants 18 participants 7 participants 5 participants 5 participants 4 participants 9 participants 7 participants 46 participants 24 participants 27 participants 40 participants 206 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  11.1%
0
   0.0%
1
  20.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
   1.9%
Not Hispanic or Latino
2
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
9
 100.0%
16
  88.9%
7
 100.0%
3
  60.0%
4
  80.0%
4
 100.0%
9
 100.0%
6
  85.7%
44
  95.7%
23
  95.8%
26
  96.3%
33
  82.5%
189
  91.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
2
   4.3%
1
   4.2%
1
   3.7%
7
  17.5%
13
   6.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 1 participants 1 participants 9 participants 18 participants 7 participants 5 participants 5 participants 4 participants 9 participants 7 participants 46 participants 24 participants 27 participants 40 participants 206 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.3%
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  28.6%
0
   0.0%
0
   0.0%
2
   7.4%
3
   7.5%
8
   3.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  22.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.3%
0
   0.0%
0
   0.0%
1
   2.5%
5
   2.4%
White
2
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
7
  77.8%
18
 100.0%
6
  85.7%
5
 100.0%
5
 100.0%
4
 100.0%
9
 100.0%
5
  71.4%
41
  89.1%
23
  95.8%
25
  92.6%
34
  85.0%
187
  90.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
1
   4.2%
0
   0.0%
2
   5.0%
4
   1.9%
1.Primary Outcome
Title Dose-Escalation Phase: Maximum Tolerated Dose (MTD) of Mirvetuximab Soravtansine
Hide Description MTD was defined as the highest dose at which 1 or fewer among 6 participants or less than or equal to (<=) 33 percent (%) experienced a dose-limiting toxicity (DLT) (calculated based on adjusted ideal body weight [AIBW]). AIBW was calculated as ideal body weight (IBW) + 0.4 * (actual weight - IBW), where IBW for men was 0.9 * height in centimeters (cm) - 88 and IBW for women was 0.9 * height in cm - 92. DLT was defined as a treatment-emergent adverse event (TEAE) or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment.
Time Frame Cycle 1 (21 days)
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Hide Analysis Population Description
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Overall Number of Participants Analyzed 44 25
Measure Type: Number
Unit of Measure: mg/kg
6.0 2.0
2.Primary Outcome
Title Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of Mirvetuximab Soravtansine
Hide Description RP2D was determined by MTD. MTD was defined as the highest dose at which 1 or fewer among 6 participants or <=33% experienced a DLT. DLT was defined as a TEAE or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. Available clinical data indicated that the MTD defined for the Q3W schedule was equal to the RP2D.
Time Frame Cycle 1 (21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: mg/kg
6.0
3.Secondary Outcome
Title Number of Participants With TEAEs
Hide Description An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 on following scale: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose.
Time Frame From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
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Hide Analysis Population Description
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Overall Number of Participants Analyzed 2 1 1 1 9 18 7 5 5 4 9 7 46 24 27 40
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
2
 100.0%
1
 100.0%
0
   0.0%
1
 100.0%
9
 100.0%
18
 100.0%
7
 100.0%
5
 100.0%
5
 100.0%
4
 100.0%
9
 100.0%
7
 100.0%
46
 100.0%
24
 100.0%
27
 100.0%
40
 100.0%
SAEs
2
 100.0%
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
  27.8%
1
  14.3%
2
  40.0%
2
  40.0%
3
  75.0%
4
  44.4%
4
  57.1%
18
  39.1%
11
  45.8%
9
  33.3%
17
  42.5%
Grade >=3 TEAEs
2
 100.0%
1
 100.0%
0
   0.0%
1
 100.0%
1
  11.1%
8
  44.4%
1
  14.3%
3
  60.0%
2
  40.0%
3
  75.0%
4
  44.4%
4
  57.1%
24
  52.2%
12
  50.0%
14
  51.9%
24
  60.0%
4.Secondary Outcome
Title Number of Participants With Shift From Baseline Grade <=2 in Clinical Laboratory Parameters to Grade 3 or Grade 4 on Study
Hide Description Laboratory parameters included serum chemistry (alanine aminotransferase [ALT]/serum glutamic pyruvic transaminase [SGPT], aspartate aminotransferase [AST]/serum glutamic oxaloacetic transaminase [SGOT], albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, magnesium, phosphorous, potassium, sodium), hematology (hemoglobin, lymphocytes, neutrophils, platelets, white blood cells) and coagulation (international normalized ratio [INR], partial thromboplastin time [PTT]). Clinically significant laboratory values were defined as per NCI CTCAE v.03 Grade 3 or higher. A grading (severity) scale was provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Only participants who shifted from a baseline value of Grade <=2 to a post-baseline Grade 3/4 on-treatment, are reported.
Time Frame From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Overall Number of Participants Analyzed 2 1 1 1 9 18 7 5 5 4 9 7 46 24 27 40
Measure Type: Count of Participants
Unit of Measure: Participants
Glucose: Grade 0 to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
Magnesium: Grade 2 to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
PTT: Grade 2 to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes: Grade 0 to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.2%
0
   0.0%
0
   0.0%
Lymphocytes: Grade 2 to Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.2%
0
   0.0%
1
   2.5%
5.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings and Vital Signs
Hide Description Physical examination included assessments of general appearance, skin, head (eyes, ears, nose, and throat), neck, lungs, heart, abdomen, back, lymph nodes, extremities, and neurological system. Vital signs included assessment of blood pressure, pulse rate, respiratory rate and body temperature.
Time Frame From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Overall Number of Participants Analyzed 2 1 1 1 9 18 7 5 5 4 9 7 46 24 27 40
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
Hide Description Standard ECGs were performed in triplicate at 2- to 5-minute intervals during the study. A single ECG was performed at the end of treatment visit and as clinically indicated.
Time Frame Baseline up to end of treatment (EOT) (up to maximum 124 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Overall Number of Participants Analyzed 2 1 1 1 9 18 7 5 5 4 9 7 46 24 27 40
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
  42.9%
2
   4.3%
1
   4.2%
1
   3.7%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Treatment-Emergent Ocular AEs
Hide Description Ocular AEs included keratopathy and blurred vision. An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose.
Time Frame From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Overall Number of Participants Analyzed 2 1 1 1 9 18 7 5 5 4 9 7 46 24 27 40
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
4
  22.2%
2
  28.6%
5
 100.0%
0
   0.0%
3
  75.0%
0
   0.0%
2
  28.6%
24
  52.2%
9
  37.5%
14
  51.9%
18
  45.0%
8.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
Hide Description Pharmacokinetic (PK) parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Time Frame Cycle 1, 3: Day 1 (pre-infusion; within 10 minutes [min] of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Arm/Group Title Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: micrograms per milliliter (mcg/mL)
Mirvetuximab soravtansine at Cycle 1 Number Analyzed 142 participants
146.9  (30.14)
Mirvetuximab soravtansine at Cycle 3 Number Analyzed 90 participants
154.6  (33.08)
Total M9346A antibody at Cycle 1 Number Analyzed 142 participants
149.2  (33.74)
Total M9346A antibody at Cycle 3 Number Analyzed 90 participants
170.4  (40.55)
9.Secondary Outcome
Title Cmax of Free DM4 and S-Methyl DM4 at RP2D
Hide Description PK parameters were calculated using standard non-compartmental methods. PK analysis of free N2'-[4-[(3-carboxypropyl)dithio]-4-methyl-1-oxo-2-sulfopentyl]-N2'-deacetylmaytansine (DM4) and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Time Frame Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Arm/Group Title Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
DM4 at Cycle 1 Number Analyzed 45 participants
5.014  (3.119)
DM4 at Cycle 3 Number Analyzed 35 participants
5.016  (2.389)
S-methyl DM4 at Cycle 1 Number Analyzed 45 participants
12.43  (12.39)
S-methyl DM4 at Cycle 3 Number Analyzed 35 participants
9.974  (5.485)
10.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
Hide Description PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Time Frame Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Arm/Group Title Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: hours*milligrams/milliliter (hr*mg/mL)
Mirvetuximab soravtansine at Cycle 1 Number Analyzed 142 participants
17.39  (4.341)
Mirvetuximab soravtansine at Cycle 3 Number Analyzed 87 participants
20.40  (5.144)
Total M9346A antibody at Cycle 1 Number Analyzed 142 participants
24.00  (7.316)
Total M9346A antibody at Cycle 3 Number Analyzed 87 participants
37.27  (12.54)
11.Secondary Outcome
Title AUC0-inf of Free DM4 and S-Methyl DM4 at RP2D
Hide Description PK parameters were calculated using standard non-compartmental methods. PK analysis of free DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Time Frame Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
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Hide Analysis Population Description
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Arm/Group Title Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: hours*nanograms/milliliter (hr*ng/mL)
DM4 at Cycle 1 Number Analyzed 38 participants
292.9  (129.2)
DM4 at Cycle 3 Number Analyzed 27 participants
290.6  (98.52)
S-methyl DM4 at Cycle 1 Number Analyzed 39 participants
2656  (2722)
S-methyl DM4 at Cycle 3 Number Analyzed 27 participants
1928  (1108)
12.Secondary Outcome
Title Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
Hide Description PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Time Frame Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Arm/Group Title Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: hr*mg/mL
Mirvetuximab soravtansine at Cycle 1 Number Analyzed 142 participants
16.44  (4.177)
Mirvetuximab soravtansine at Cycle 3 Number Analyzed 87 participants
18.91  (4.940)
Total M9346A antibody at Cycle 1 Number Analyzed 142 participants
20.27  (5.903)
Total M9346A antibody at Cycle 3 Number Analyzed 87 participants
29.29  (9.613)
13.Secondary Outcome
Title AUClast of Free DM4 and S-Methyl DM4 at RP2D
Hide Description PK parameters were calculated using standard non-compartmental methods. PK analysis of free DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Time Frame Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Arm/Group Title Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
DM4 at Cycle 1 Number Analyzed 43 participants
246.0  (133.3)
DM4 at Cycle 3 Number Analyzed 27 participants
270.1  (95.62)
S-methyl DM4 at Cycle 1 Number Analyzed 45 participants
2485  (2536)
S-methyl DM4 at Cycle 3 Number Analyzed 27 participants
1806  (1046)
14.Secondary Outcome
Title Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-Methyl DM4 at RP2D
Hide Description PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, total M9346A antibody, DM4, and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Time Frame Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Arm/Group Title Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: hours
Mirvetuximab soravtansine at Cycle 1 Number Analyzed 142 participants
119.4  (22.58)
Mirvetuximab soravtansine at Cycle 3 Number Analyzed 90 participants
127.8  (34.11)
Total M9346A antibody at Cycle 1 Number Analyzed 142 participants
186.7  (54.04)
Total M9346A antibody at Cycle 3 Number Analyzed 90 participants
218.8  (71.46)
DM4 at Cycle 1 Number Analyzed 38 participants
73.80  (28.99)
DM4 at Cycle 3 Number Analyzed 30 participants
80.62  (26.12)
S-methyl DM4 at Cycle 1 Number Analyzed 39 participants
122.2  (25.23)
S-methyl DM4 at Cycle 3 Number Analyzed 32 participants
130.4  (23.47)
15.Secondary Outcome
Title Clearance (CL) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D
Hide Description PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Time Frame Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Arm/Group Title Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: milliliters per hour (mL/hr)
Mirvetuximab soravtansine at Cycle 1 Number Analyzed 141 participants
22.20  (6.476)
Mirvetuximab soravtansine at Cycle 3 Number Analyzed 87 participants
19.80  (4.953)
Total M9346A antibody at Cycle 1 Number Analyzed 141 participants
16.89  (7.155)
Total M9346A antibody at Cycle 3 Number Analyzed 87 participants
13.26  (4.956)
16.Secondary Outcome
Title CL of DM4 and S-Methyl DM4 at RP2D
Hide Description PK parameters were calculated using standard non-compartmental methods. PK analysis of DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Time Frame Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Arm/Group Title Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: Liters per hour (L/hr)
DM4 at Cycle 1 Number Analyzed 38 participants
1421  (560.2)
DM4 at Cycle 3 Number Analyzed 27 participants
1338  (438.8)
S-methyl DM4 at Cycle 1 Number Analyzed 39 participants
218.9  (128.5)
S-methyl DM4 at Cycle 3 Number Analyzed 27 participants
258.4  (173.8)
17.Secondary Outcome
Title Time to Reach Maximum Observed Concentration (Tmax) of Mirvetuximab Soravtansine, Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D
Hide Description PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, free DM4, S-methyl DM4, and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Time Frame Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Arm/Group Title Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Overall Number of Participants Analyzed 142
Median (Full Range)
Unit of Measure: hours
Mirvetuximab soravtansine at Cycle 1 Number Analyzed 142 participants
3.80
(1.2 to 24)
Mirvetuximab soravtansine at Cycle 3 Number Analyzed 90 participants
3.20
(1.1 to 47)
Total M9346A antibody at Cycle 1 Number Analyzed 142 participants
3.60
(1.1 to 53)
Total M9346A antibody at Cycle 3 Number Analyzed 90 participants
3.20
(0.93 to 170)
DM4 at Cycle 1 Number Analyzed 45 participants
5.80
(1.7 to 500)
DM4 at Cycle 3 Number Analyzed 35 participants
5.00
(1.1 to 670)
S-methyl DM4 at Cycle 1 Number Analyzed 45 participants
49.0
(5.8 to 500)
S-methyl DM4 at Cycle 3 Number Analyzed 35 participants
23.0
(4.5 to 670)
18.Secondary Outcome
Title Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D
Hide Description PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, free DM4, S-methyl DM4, and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.
Time Frame Cycle 1, 3: Day 1 (pre-infusion; within 10 min of EOI; 2, 4, 6, 8 hrs post-infusion); Day 2, 3 (24, 48 hrs post-infusion); Day 4 or 5, 8, 15 (24 hrs post-infusion)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.
Arm/Group Title Mirvetuximab Soravtansine 6.0 mg/kg AIBW
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: Liters
Mirvetuximab soravtansine at Cycle 1 Number Analyzed 141 participants
3.198  (0.7422)
Mirvetuximab soravtansine at Cycle 3 Number Analyzed 87 participants
3.172  (1.022)
Total M9346A antibody at Cycle 1 Number Analyzed 141 participants
3.744  (0.9183)
Total M9346A antibody at Cycle 3 Number Analyzed 87 participants
3.671  (1.185)
DM4 at Cycle 1 Number Analyzed 38 participants
107400  (38770)
DM4 at Cycle 3 Number Analyzed 27 participants
114300  (48740)
S-methyl DM4 at Cycle 1 Number Analyzed 39 participants
41590  (27890)
S-methyl DM4 at Cycle 3 Number Analyzed 27 participants
47520  (40440)
19.Secondary Outcome
Title Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Hide Description ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
Time Frame From first dose of study drug until first BOR of CR or PR (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
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Hide Analysis Population Description
Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly) Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W) Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Overall Number of Participants Analyzed 43 24 113 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5
(0.6 to 15.8)
13
(2.7 to 32.4)
30
(21.8 to 39.4)
8
(1.0 to 27.0)
20.Secondary Outcome
Title Duration of Response (DOR) as Assessed by RECIST v1.1
Hide Description DOR was defined as the time from the date of the first response (CR or PR), whichever was recorded first, until the date of progressive disease (PD). PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was only defined for participants who had a BOR of CR or PR using the method of Kaplan-Meier.
Time Frame From the date of first response (CR or PR) until the date of PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
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Hide Analysis Population Description
Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. 'Overall number of participants analyzed'=participants who had a BOR of CR or PR. Data by group only.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly) Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W) Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Overall Number of Participants Analyzed 2 3 34 2
Median (95% Confidence Interval)
Unit of Measure: weeks
21.3
(18.4 to 24.1)
60.2
(44.3 to 76.1)
19.3
(18.0 to 34.0)
28.6 [1] 
(NA to NA)
[1]
Due to smaller number of events, 95% CI could not be calculated.
21.Secondary Outcome
Title Progression-Free Survival (PFS) as Assessed by RECIST v1.1
Hide Description PFS was defined as the time from initiation of study drug until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time Frame From first dose of study drug until PD or death whichever occurred first (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
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Hide Analysis Population Description
Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly) Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W) Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Overall Number of Participants Analyzed 43 24 113 24
Median (95% Confidence Interval)
Unit of Measure: months
2.6
(1.3 to 3.3)
3.9
(1.8 to 11.1)
4.3
(3.9 to 5.4)
2.8
(1.2 to 4.2)
22.Secondary Outcome
Title Time to Progression (TTP) as Assessed by RECIST v1.1
Hide Description TTP was defined as the time from initiation of study drug until PD, estimated using the method of Kaplan-Meier. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time Frame From first dose of study drug until PD (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly) Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W) Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Overall Number of Participants Analyzed 43 24 113 24
Median (95% Confidence Interval)
Unit of Measure: months
2.7
(1.3 to 3.3)
3.9
(1.8 to 11.1)
4.4
(4.0 to 5.6)
2.8
(1.2 to 6.9)
23.Secondary Outcome
Title Number of Participants With Anti-Drug Antibodies (ADA)
Hide Description During the conduct of the study, a single immunogenicity assay was developed to concurrently detect human antibodies against all components of mirvetuximab soravtansine, including the humanized anti-FOLR1 antibody, the cleavable disulfide linker, and the cytotoxic maytansinoid, DM4. Therefore, immunogenicity results were reported as ADA titers, and did not distinguish between human anti-drug or anti-human titers.
Time Frame Baseline up to follow-up visit (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable immunogenicity data.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Overall Number of Participants Analyzed 2 1 1 1 9 18 7 5 5 4 9 7 46 24 27 40
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
1
  11.1%
1
   5.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
7
  29.2%
2
   7.4%
2
   5.0%
24.Secondary Outcome
Title Number of Participants With Gynecologic Cancer Intergroup (GCIG) CA-125 Criteria Clinical Responses
Hide Description CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The date of response corresponded to the date when the CA 125 level was first reduced by 50%.
Time Frame From first dose of study drug until CA-125 response (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Hide Outcome Measure Data
Hide Analysis Population Description
CA-125 evaluable population included participants who had a baseline CA-125 value greater than or equal to (>=) 2 * upper limit of normal (ULN), received at least 1 dose of study drug, and had at least 1 post-dose CA-125 assessment.
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description:
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Overall Number of Participants Analyzed 1 0 0 1 3 10 2 3 2 2 4 5 31 12 20 26
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0 0
0
   0.0%
0
   0.0%
3
  30.0%
1
  50.0%
1
  33.3%
1
  50.0%
2
 100.0%
2
  50.0%
3
  60.0%
23
  74.2%
4
  33.3%
11
  55.0%
17
  65.4%
Time Frame From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Adverse Event Reporting Description Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data was only collected and reported by combined groups for the dose-escalation phase and not by individual doses.
 
Arm/Group Title Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Hide Arm/Group Description Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study. Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
All-Cause Mortality
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/9 (0.00%)   1/18 (5.56%)   0/7 (0.00%)   0/5 (0.00%)   0/5 (0.00%)   0/4 (0.00%)   1/9 (11.11%)   0/7 (0.00%)   4/46 (8.70%)   4/24 (16.67%)   1/27 (3.70%)   4/40 (10.00%) 
Hide Serious Adverse Events
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   0/1 (0.00%)   1/1 (100.00%)   0/1 (0.00%)   0/9 (0.00%)   5/18 (27.78%)   1/7 (14.29%)   2/5 (40.00%)   2/5 (40.00%)   3/4 (75.00%)   4/9 (44.44%)   4/7 (57.14%)   18/46 (39.13%)   11/24 (45.83%)   9/27 (33.33%)   17/40 (42.50%) 
Blood and lymphatic system disorders                                 
Febrile neutropenia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Thrombocytopenia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/40 (0.00%) 
Cardiac disorders                                 
Atrial fibrillation  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/7 (14.29%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Eye disorders                                 
Corneal opacity  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Punctate keratitis  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Gastrointestinal disorders                                 
Small intestinal obstruction  1  0/2 (0.00%)  0/1 (0.00%)  1/1 (100.00%)  0/1 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  1/9 (11.11%)  0/7 (0.00%)  2/46 (4.35%)  0/24 (0.00%)  0/27 (0.00%)  7/40 (17.50%) 
Gastritis  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Abdominal pain  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  3/40 (7.50%) 
Diarrhoea  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/46 (0.00%)  2/24 (8.33%)  0/27 (0.00%)  0/40 (0.00%) 
Intestinal obstruction  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Vomiting  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  2/46 (4.35%)  1/24 (4.17%)  0/27 (0.00%)  3/40 (7.50%) 
Constipation  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  1/24 (4.17%)  1/27 (3.70%)  1/40 (2.50%) 
Large intestinal obstruction  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  2/24 (8.33%)  0/27 (0.00%)  0/40 (0.00%) 
Nausea  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  1/40 (2.50%) 
Ascites  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/40 (0.00%) 
Enteritis  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Enterocutaneous fistula  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Gastrointestinal haemorrhage  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Intestinal perforation  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  1/40 (2.50%) 
Oesophagitis  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  1/40 (2.50%) 
General disorders                                 
Asthenia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/40 (0.00%) 
Fatigue  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Pyrexia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  1/40 (2.50%) 
Hepatobiliary disorders                                 
Gallbladder obstruction  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/40 (0.00%) 
Hyperbilirubinaemia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  1/27 (3.70%)  0/40 (0.00%) 
Immune system disorders                                 
Hypersensitivity  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Infections and infestations                                 
Pneumonia  1  1/2 (50.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  1/24 (4.17%)  0/27 (0.00%)  1/40 (2.50%) 
Influenza  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Urinary tract infection  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  1/46 (2.17%)  2/24 (8.33%)  0/27 (0.00%)  0/40 (0.00%) 
Gastroenteritis  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  2/46 (4.35%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Abdominal wall abscess  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Cystitis  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  1/27 (3.70%)  0/40 (0.00%) 
Device related infection  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Haemophilus infection  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  1/27 (3.70%)  0/40 (0.00%) 
Septic shock  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Wound infection  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  1/40 (2.50%) 
Injury, poisoning and procedural complications                                 
Hip fracture  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  1/5 (20.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/40 (0.00%) 
Humerus fracture  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Spinal fracture  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/40 (0.00%) 
Investigations                                 
Electrocardiogram QT prolonged  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Metabolism and nutrition disorders                                 
Hypokalaemia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Hypomagnesaemia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Hypophosphataemia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Hypoglycaemia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Dehydration  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  3/46 (6.52%)  0/24 (0.00%)  0/27 (0.00%)  1/40 (2.50%) 
Decreased appetite  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  2/46 (4.35%)  0/24 (0.00%)  0/27 (0.00%)  1/40 (2.50%) 
Hyponatraemia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Musculoskeletal and connective tissue disorders                                 
Back pain  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Muscle spasms  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Arthritis  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  1/40 (2.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                                 
Metastatic neoplasm  1  1/2 (50.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  1/27 (3.70%)  1/40 (2.50%) 
Metastases to central nervous system  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  1/24 (4.17%)  0/27 (0.00%)  0/40 (0.00%) 
Metastases to meninges  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/40 (0.00%) 
Renal and urinary disorders                                 
Haematuria  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Pulmonary embolism  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Respiratory, thoracic and mediastinal disorders                                 
Hypoxia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  1/4 (25.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Pulmonary oedema  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Respiratory failure  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Organising pneumonia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  1/46 (2.17%)  0/24 (0.00%)  1/27 (3.70%)  0/40 (0.00%) 
Pneumonitis  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  3/46 (6.52%)  1/24 (4.17%)  4/27 (14.81%)  7/40 (17.50%) 
Aspiration  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/40 (0.00%) 
Pleural effusion  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  1/27 (3.70%)  0/40 (0.00%) 
Pneumonia aspiration  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/46 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/40 (0.00%) 
Pulmonary fibrosis  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Vascular disorders                                 
Deep vein thrombosis  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Superior vena cava syndrome  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/46 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
Hypotension  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  0/7 (0.00%)  0/5 (0.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/46 (2.17%)  0/24 (0.00%)  0/27 (0.00%)  0/40 (0.00%) 
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   0/1 (0.00%)   1/1 (100.00%)   1/1 (100.00%)   9/9 (100.00%)   18/18 (100.00%)   7/7 (100.00%)   5/5 (100.00%)   5/5 (100.00%)   4/4 (100.00%)   9/9 (100.00%)   7/7 (100.00%)   45/46 (97.83%)   24/24 (100.00%)   27/27 (100.00%)   40/40 (100.00%) 
Blood and lymphatic system disorders                                 
Anaemia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  2/9 (22.22%)  2/18 (11.11%)  0/7 (0.00%)  0/5 (0.00%)  1/5 (20.00%)  0/4 (0.00%)  3/9 (33.33%)  1/7 (14.29%)  6/46 (13.04%)  2/24 (8.33%)  1/27 (3.70%)  4/40 (10.00%) 
Thrombocytopenia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  2/7 (28.57%)  1/5 (20.00%)  0/5 (0.00%)  0/4 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  7/46 (15.22%)  3/24 (12.50%)  0/27 (0.00%)  2/40 (5.00%) 
Lymphopenia  1  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/1 (0.00%)  0/9 (0.00%)  2/18 (11.11%)  0/7 (0.00%)  0/5 (0.00%)