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Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.

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: NCT02460224
Recruitment Status : Completed
First Posted : June 2, 2015
Results First Posted : February 10, 2022
Last Update Posted : February 10, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Solid Tumors
Interventions Drug: LAG525
Drug: PDR001
Enrollment 490
Recruitment Details Participants took part in 25 investigative sites in 12 countries.
Pre-assignment Details The screening period began once patients had signed the study informed consent. All screening/baseline evaluations were performed ≤ 21 days before Cycle 1 Day 1, except for baseline radiological evaluations which had to be done within 28 days.
Arm/Group Title Phase 1: LAG525 1 mg/kg Q2W Phase 1: LAG525 3 mg/kg Q2W Phase 1: LAG525 5 mg/kg Q2W Phase 1: LAG525 10 mg/kg Q2W Phase 1: LAG525 15 mg/kg Q2W Phase 1: LAG525 240 mg Q2W Phase 1: LAG525 400 mg Q2W Phase 1: LAG525 3 mg/kg Q4W Phase 1: LAG525 5 mg/kg Q4W Phase 1: LAG525 10 mg/kg Q4W Phase 1: LAG525 400 mg Q4W Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Hide Arm/Group Description Single-agent LAG525 1 mg/kg Q2W Single-agent LAG525 3 mg/kg Q2W Single-agent LAG525 5 mg/kg Q2W Single-agent LAG525 10 mg/kg Q2W Single-agent LAG525 15 mg/kg Q2W Single-agent LAG525 240 mg Q2W Single-agent LAG525 400 mg Q2W Single-agent LAG525 3 mg/kg Q4W Single-agent LAG525 5 mg/kg Q4W Single-agent LAG525 10 mg/kg Q4W Single-agent LAG525 400 mg Q4W Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W) Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W) Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W) Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W) Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W) Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W) Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W) Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W) Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W) Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W) Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W) Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W) Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W) Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W) Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1 Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1 Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Period Title: Overall Study
Started 17 12 6 6 6 30 30 5 6 11 5 6 6 6 5 6 20 6 12 7 6 12 6 11 6 6 121 21 93
Rest of the World Patients in the Dose Escalation Part 13 12 6 6 6 25 24 5 6 11 5 6 6 6 5 6 20 6 12 7 6 12 6 11 6 6 0 0 0
Japanese Patients in the Dose Escalation Part 4 0 0 0 0 5 6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Completed 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
Not Completed 17 12 6 6 6 30 30 5 6 11 5 6 6 6 5 6 20 6 12 7 6 12 6 11 6 6 121 21 93
Reason Not Completed
Adverse Event             0             0             0             0             0             0             1             0             0             0             0             0             1             0             0             0             1             0             1             0             1             1             1             0             0             0             11             1             6
Death             0             0             0             0             0             2             1             0             0             1             0             0             0             1             0             0             2             1             0             2             0             0             0             0             1             1             5             0             1
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0
Physician Decision             0             1             0             0             1             0             0             1             0             0             0             1             0             1             0             0             2             1             1             2             1             1             0             0             1             0             14             1             6
Progressive disease             15             11             5             6             3             26             28             4             5             9             5             4             5             4             5             5             15             3             8             3             4             9             4             11             4             5             85             17             77
Subject/guardian decision             2             0             1             0             2             2             0             0             1             1             0             1             0             0             0             1             0             1             2             0             0             1             0             0             0             0             6             2             3
Arm/Group Title Phase 1: LAG525 1 mg/kg Q2W Phase 1: LAG525 3 mg/kg Q2W Phase 1: LAG525 5 mg/kg Q2W Phase 1: LAG525 10 mg/kg Q2W Phase 1: LAG525 15 mg/kg Q2W Phase 1: LAG525 240 mg Q2W Phase 1: LAG525 400 mg Q2W Phase 1: LAG525 3 mg/kg Q4W Phase 1: LAG525 5 mg/kg Q4W Phase 1: LAG525 10 mg/kg Q4W Phase 1: LAG525 400 mg Q4W Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W Total
Hide Arm/Group Description Single-agent LAG525 1 mg/kg Q2W Single-agent LAG525 3 mg/kg Q2W Single-agent LAG525 5 mg/kg Q2W Single-agent LAG525 10 mg/kg Q2W Single-agent LAG525 15 mg/kg Q2W Single-agent LAG525 240 mg Q2W Single-agent LAG525 400 mg Q2W Single-agent LAG525 3 mg/kg Q4W Single-agent LAG525 5 mg/kg Q4W Single-agent LAG525 10 mg/kg Q4W Single-agent LAG525 400 mg Q4W Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W) Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W) Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W) Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W) Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W) Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W) Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W) Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W) Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W) Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W) Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W) Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W) Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W) Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W) Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1 Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1 Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1 Total of all reporting groups
Overall Number of Baseline Participants 17 12 6 6 6 30 30 5 6 11 5 6 6 6 5 6 20 6 12 7 6 12 6 11 6 6 121 21 93 490
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 12 participants 6 participants 6 participants 6 participants 30 participants 30 participants 5 participants 6 participants 11 participants 5 participants 6 participants 6 participants 6 participants 5 participants 6 participants 20 participants 6 participants 12 participants 7 participants 6 participants 12 participants 6 participants 11 participants 6 participants 6 participants 121 participants 21 participants 93 participants 490 participants
56.1  (12.55) 64.5  (12.43) 61.8  (13.32) 53.3  (20.76) 61.2  (9.58) 57.2  (10.94) 56.7  (10.82) 60.8  (9.36) 54.8  (17.26) 59.5  (7.16) 60.4  (7.16) 54.3  (8.78) 58.0  (5.90) 44.8  (5.23) 58.2  (10.03) 48.7  (24.36) 59.1  (12.83) 61.2  (11.34) 61.3  (8.25) 51.1  (12.03) 59.8  (8.11) 51.8  (12.10) 59.2  (5.42) 56.6  (10.31) 60.7  (6.89) 52.3  (12.50) 61.0  (10.79) 49.4  (8.94) 58.4  (11.18) 58.1  (11.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 12 participants 6 participants 6 participants 6 participants 30 participants 30 participants 5 participants 6 participants 11 participants 5 participants 6 participants 6 participants 6 participants 5 participants 6 participants 20 participants 6 participants 12 participants 7 participants 6 participants 12 participants 6 participants 11 participants 6 participants 6 participants 121 participants 21 participants 93 participants 490 participants
Female
7
  41.2%
6
  50.0%
3
  50.0%
4
  66.7%
4
  66.7%
17
  56.7%
14
  46.7%
2
  40.0%
4
  66.7%
6
  54.5%
2
  40.0%
3
  50.0%
3
  50.0%
2
  33.3%
1
  20.0%
3
  50.0%
9
  45.0%
3
  50.0%
11
  91.7%
3
  42.9%
3
  50.0%
7
  58.3%
5
  83.3%
6
  54.5%
4
  66.7%
3
  50.0%
53
  43.8%
20
  95.2%
40
  43.0%
248
  50.6%
Male
10
  58.8%
6
  50.0%
3
  50.0%
2
  33.3%
2
  33.3%
13
  43.3%
16
  53.3%
3
  60.0%
2
  33.3%
5
  45.5%
3
  60.0%
3
  50.0%
3
  50.0%
4
  66.7%
4
  80.0%
3
  50.0%
11
  55.0%
3
  50.0%
1
   8.3%
4
  57.1%
3
  50.0%
5
  41.7%
1
  16.7%
5
  45.5%
2
  33.3%
3
  50.0%
68
  56.2%
1
   4.8%
53
  57.0%
242
  49.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 12 participants 6 participants 6 participants 6 participants 30 participants 30 participants 5 participants 6 participants 11 participants 5 participants 6 participants 6 participants 6 participants 5 participants 6 participants 20 participants 6 participants 12 participants 7 participants 6 participants 12 participants 6 participants 11 participants 6 participants 6 participants 121 participants 21 participants 93 participants 490 participants
Caucasian
8
  47.1%
9
  75.0%
5
  83.3%
3
  50.0%
6
 100.0%
20
  66.7%
20
  66.7%
2
  40.0%
4
  66.7%
10
  90.9%
3
  60.0%
2
  33.3%
6
 100.0%
6
 100.0%
4
  80.0%
5
  83.3%
20
 100.0%
6
 100.0%
10
  83.3%
7
 100.0%
4
  66.7%
8
  66.7%
5
  83.3%
9
  81.8%
5
  83.3%
6
 100.0%
69
  57.0%
15
  71.4%
70
  75.3%
347
  70.8%
Black
1
   5.9%
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%
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
   4.8%
1
   1.1%
4
   0.8%
Asian
8
  47.1%
2
  16.7%
1
  16.7%
3
  50.0%
0
   0.0%
10
  33.3%
10
  33.3%
1
  20.0%
1
  16.7%
0
   0.0%
2
  40.0%
3
  50.0%
0
   0.0%
0
   0.0%
1
  20.0%
1
  16.7%
0
   0.0%
0
   0.0%
2
  16.7%
0
   0.0%
2
  33.3%
2
  16.7%
1
  16.7%
2
  18.2%
1
  16.7%
0
   0.0%
48
  39.7%
4
  19.0%
17
  18.3%
122
  24.9%
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%
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
   1.1%
1
   0.2%
Unknown
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
  16.7%
1
   9.1%
0
   0.0%
1
  16.7%
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
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.7%
1
   4.8%
4
   4.3%
12
   2.4%
Other
0
   0.0%
1
   8.3%
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%
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
   1.7%
0
   0.0%
0
   0.0%
4
   0.8%
1.Primary Outcome
Title Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
Hide Description A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Time Frame 15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms
Hide Outcome Measure Data
Hide Analysis Population Description

All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001, and who either completed a minimum exposure requirement or who had a DLT during the first 15 days of treatment (1 cycle) for single-agent LAG525 arms or the first 30 days (2 cycles) for the LAG525 + PDR001 arms.

Japanese patients were analyzed together with the rest of the world (ROW) patients as per protocol.

Arm/Group Title Phase 1: LAG525 1 mg/kg Q2W Phase 1: LAG525 3 mg/kg Q2W Phase 1: LAG525 5 mg/kg Q2W Phase 1: LAG525 10 mg/kg Q2W Phase 1: LAG525 15 mg/kg Q2W Phase 1: LAG525 240 mg Q2W Phase 1: LAG525 400 mg Q2W Phase 1: LAG525 3 mg/kg Q4W Phase 1: LAG525 5 mg/kg Q4W Phase 1: LAG525 10 mg/kg Q4W Phase 1: LAG525 400 mg Q4W Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Hide Arm/Group Description:
Single-agent LAG525 1 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Single-agent LAG525 240 mg Q2W
Single-agent LAG525 400 mg Q2W
Single-agent LAG525 3 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Single-agent LAG525 400 mg Q4W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Overall Number of Participants Analyzed 16 12 6 5 6 28 27 5 6 11 5 6 6 5 5 5 17 4 9 5 6 11 6 11 5 6
Measure Type: Count of Participants
Unit of Measure: Participants
1
   6.3%
0
   0.0%
2
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
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
  11.1%
0
   0.0%
1
  16.7%
0
   0.0%
1
  16.7%
1
   9.1%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Phase 2: Overall Response Rate (ORR) Per RECIST 1.1
Hide Description

Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR).

For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters.

ORR is reported by tumor type.

Time Frame From start of treatment until end of treatment, assessed up to 2.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Arm/Group Title Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Hide Arm/Group Description:
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Overall Number of Participants Analyzed 121 21 93
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Non-small cell lung cancer (NSCLC) Number Analyzed 20 participants 0 participants 22 participants
15.0
(4.2 to 34.4)
0
(0.0 to 12.7)
Melanoma Number Analyzed 20 participants 0 participants 22 participants
15.0
(4.2 to 34.4)
9.1
(1.6 to 25.9)
Renal cell cancer (RCC) Number Analyzed 19 participants 0 participants 19 participants
26.3
(11.0 to 47.6)
5.3
(0.3 to 22.6)
Mesothelioma Number Analyzed 41 participants 0 participants 16 participants
17.1
(8.3 to 29.7)
6.3
(0.3 to 26.4)
Triple negative breast cancer (TNBC) Number Analyzed 21 participants 21 participants 14 participants
14.3
(4.0 to 32.9)
4.8
(0.2 to 20.7)
0
(0.0 to 19.3)
3.Secondary Outcome
Title Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants in each category (Rest of the World (ROW) patients, Japanese patients) with AEs and SAEs are reported in this record.
Time Frame From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
Arm/Group Title Phase 1: LAG525 1 mg/kg Q2W Phase 1: LAG525 3 mg/kg Q2W Phase 1: LAG525 5 mg/kg Q2W Phase 1: LAG525 10 mg/kg Q2W Phase 1: LAG525 15 mg/kg Q2W Phase 1: LAG525 240 mg Q2W Phase 1: LAG525 400 mg Q2W Phase 1: LAG525 3 mg/kg Q4W Phase 1: LAG525 5 mg/kg Q4W Phase 1: LAG525 10 mg/kg Q4W Phase 1: LAG525 400 mg Q4W Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Hide Arm/Group Description:
Single-agent LAG525 1 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Single-agent LAG525 240 mg Q2W
Single-agent LAG525 400 mg Q2W
Single-agent LAG525 3 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Single-agent LAG525 400 mg Q4W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Overall Number of Participants Analyzed 17 12 6 6 6 30 30 5 6 11 5 6 6 6 5 6 20 6 12 7 6 12 6 11 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
AEs, ROW patients Number Analyzed 13 participants 12 participants 6 participants 6 participants 6 participants 25 participants 24 participants 5 participants 6 participants 11 participants 5 participants 6 participants 6 participants 6 participants 5 participants 6 participants 20 participants 6 participants 12 participants 7 participants 6 participants 12 participants 6 participants 11 participants 6 participants 6 participants
13
 100.0%
11
  91.7%
6
 100.0%
6
 100.0%
6
 100.0%
24
  96.0%
24
 100.0%
5
 100.0%
6
 100.0%
11
 100.0%
5
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
5
 100.0%
6
 100.0%
19
  95.0%
6
 100.0%
12
 100.0%
7
 100.0%
6
 100.0%
12
 100.0%
6
 100.0%
11
 100.0%
6
 100.0%
6
 100.0%
SAEs, ROW patients Number Analyzed 13 participants 12 participants 6 participants 6 participants 6 participants 25 participants 24 participants 5 participants 6 participants 11 participants 5 participants 6 participants 6 participants 6 participants 5 participants 6 participants 20 participants 6 participants 12 participants 7 participants 6 participants 12 participants 6 participants 11 participants 6 participants 6 participants
4
  30.8%
2
  16.7%
5
  83.3%
2
  33.3%
3
  50.0%
10
  40.0%
11
  45.8%
2
  40.0%
4
  66.7%
5
  45.5%
2
  40.0%
3
  50.0%
2
  33.3%
3
  50.0%
3
  60.0%
1
  16.7%
9
  45.0%
3
  50.0%
6
  50.0%
4
  57.1%
5
  83.3%
5
  41.7%
2
  33.3%
5
  45.5%
4
  66.7%
4
  66.7%
AEs, Japanese patients Number Analyzed 4 participants 0 participants 0 participants 0 participants 0 participants 5 participants 6 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
4
 100.0%
5
 100.0%
6
 100.0%
SAEs, Japanese patients Number Analyzed 4 participants 0 participants 0 participants 0 participants 0 participants 5 participants 6 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
2
  40.0%
0
   0.0%
4.Secondary Outcome
Title Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants with AEs and SAEs is reported for each tumor type.
Time Frame From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 2.7 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Arm/Group Title Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Hide Arm/Group Description:
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Overall Number of Participants Analyzed 121 21 93
Measure Type: Count of Participants
Unit of Measure: Participants
AEs, Non-small cell lung cancer (NSCLC) Number Analyzed 20 participants 0 participants 22 participants
19
  95.0%
22
 100.0%
SAEs, Non-small cell lung cancer (NSCLC) Number Analyzed 20 participants 0 participants 22 participants
13
  65.0%
7
  31.8%
AEs, Melanoma Number Analyzed 20 participants 0 participants 22 participants
19
  95.0%
22
 100.0%
SAEs, Melanoma Number Analyzed 20 participants 0 participants 22 participants
8
  40.0%
8
  36.4%
AEs, Renal cell cancer (RCC) Number Analyzed 19 participants 0 participants 19 participants
19
 100.0%
19
 100.0%
SAEs, Renal cell cancer (RCC) Number Analyzed 19 participants 0 participants 19 participants
14
  73.7%
5
  26.3%
AEs, Mesothelioma Number Analyzed 41 participants 0 participants 16 participants
41
 100.0%
16
 100.0%
SAEs, Mesothelioma Number Analyzed 41 participants 0 participants 16 participants
15
  36.6%
4
  25.0%
AEs, Triple negative breast cancer (TNBC) Number Analyzed 21 participants 21 participants 14 participants
21
 100.0%
21
 100.0%
14
 100.0%
SAEs, Triple negative breast cancer (TNBC) Number Analyzed 21 participants 21 participants 14 participants
9
  42.9%
10
  47.6%
4
  28.6%
5.Secondary Outcome
Title Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
Hide Description

Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001.

Japanese patients were not treated with PDR001 and therefore the dose reductions and dose interruptions of this study drug are not applicable.

Time Frame From start of treatment until end of treatment, assessed up to 4.4 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
Arm/Group Title Phase 1: LAG525 1 mg/kg Q2W Phase 1: LAG525 3 mg/kg Q2W Phase 1: LAG525 5 mg/kg Q2W Phase 1: LAG525 10 mg/kg Q2W Phase 1: LAG525 15 mg/kg Q2W Phase 1: LAG525 240 mg Q2W Phase 1: LAG525 400 mg Q2W Phase 1: LAG525 3 mg/kg Q4W Phase 1: LAG525 5 mg/kg Q4W Phase 1: LAG525 10 mg/kg Q4W Phase 1: LAG525 400 mg Q4W Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Hide Arm/Group Description:
Single-agent LAG525 1 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Single-agent LAG525 240 mg Q2W
Single-agent LAG525 400 mg Q2W
Single-agent LAG525 3 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Single-agent LAG525 400 mg Q4W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Overall Number of Participants Analyzed 17 12 6 6 6 30 30 5 6 11 5 6 6 6 5 6 20 6 12 7 6 12 6 11 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
LAG525 dose reduction, ROW patients Number Analyzed 13 participants 12 participants 6 participants 6 participants 6 participants 25 participants 24 participants 5 participants 6 participants 11 participants 5 participants 6 participants 6 participants 6 participants 5 participants 6 participants 20 participants 6 participants 12 participants 7 participants 6 participants 12 participants 6 participants 11 participants 6 participants 6 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%
1
  16.7%
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
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
LAG525 dose interruption, ROW patients Number Analyzed 13 participants 12 participants 6 participants 6 participants 6 participants 25 participants 24 participants 5 participants 6 participants 11 participants 5 participants 6 participants 6 participants 6 participants 5 participants 6 participants 20 participants 6 participants 12 participants 7 participants 6 participants 12 participants 6 participants 11 participants 6 participants 6 participants
2
  15.4%
2
  16.7%
1
  16.7%
1
  16.7%
1
  16.7%
1
   4.0%
1
   4.2%
1
  20.0%
0
   0.0%
2
  18.2%
0
   0.0%
4
  66.7%
1
  16.7%
2
  33.3%
1
  20.0%
1
  16.7%
6
  30.0%
2
  33.3%
2
  16.7%
1
  14.3%
2
  33.3%
3
  25.0%
0
   0.0%
4
  36.4%
1
  16.7%
1
  16.7%
PDR001 dose reduction, ROW patients Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 6 participants 6 participants 6 participants 5 participants 6 participants 20 participants 6 participants 12 participants 7 participants 6 participants 12 participants 6 participants 11 participants 6 participants 6 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%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PDR001 dose interruption, ROW patients Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 6 participants 6 participants 6 participants 5 participants 6 participants 20 participants 6 participants 12 participants 7 participants 6 participants 12 participants 6 participants 11 participants 6 participants 6 participants
4
  66.7%
1
  16.7%
2
  33.3%
1
  20.0%
0
   0.0%
6
  30.0%
2
  33.3%
2
  16.7%
1
  14.3%
2
  33.3%
3
  25.0%
0
   0.0%
3
  27.3%
0
   0.0%
1
  16.7%
LAG525 dose reduction, Japanese patients Number Analyzed 4 participants 0 participants 0 participants 0 participants 0 participants 5 participants 6 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
LAG525 dose interruption, Japanese patients Number Analyzed 4 participants 0 participants 0 participants 0 participants 0 participants 5 participants 6 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
2
  40.0%
2
  33.3%
6.Secondary Outcome
Title Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
Hide Description

Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001.

The number of participants with dose reductions and dose interruptions of both study drugs is reported for each tumor type.

Time Frame From start of treatment until end of treatment, assessed up to 2.6 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Arm/Group Title Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Hide Arm/Group Description:
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Overall Number of Participants Analyzed 121 21 93
Measure Type: Count of Participants
Unit of Measure: Participants
LAG525 dose reduction, NSCLC patients Number Analyzed 20 participants 0 participants 22 participants
0
   0.0%
0
   0.0%
LAG525 dose interruption, NSCLC patients Number Analyzed 20 participants 0 participants 22 participants
3
  15.0%
3
  13.6%
PDR001 dose reduction, NSCLC patients Number Analyzed 20 participants 0 participants 22 participants
0
   0.0%
0
   0.0%
PDR001 dose interruption, NSCLC patients Number Analyzed 20 participants 0 participants 22 participants
3
  15.0%
3
  13.6%
LAG525 dose reduction, melanoma patients Number Analyzed 20 participants 0 participants 22 participants
0
   0.0%
0
   0.0%
LAG525 dose interruption, melanoma patients Number Analyzed 20 participants 0 participants 22 participants
4
  20.0%
4
  18.2%
PDR001 dose reduction, melanoma patients Number Analyzed 20 participants 0 participants 22 participants
0
   0.0%
0
   0.0%
PDR001 dose interruption, melanoma patients Number Analyzed 20 participants 0 participants 22 participants
4
  20.0%
4
  18.2%
LAG525 dose reduction, RCC patients Number Analyzed 19 participants 0 participants 19 participants
0
   0.0%
0
   0.0%
LAG525 dose interruption, RCC patients Number Analyzed 19 participants 0 participants 19 participants
5
  26.3%
1
   5.3%
PDR001 dose reduction, RCC patients Number Analyzed 19 participants 0 participants 19 participants
0
   0.0%
0
   0.0%
PDR001 dose interruption, RCC patients Number Analyzed 19 participants 0 participants 19 participants
5
  26.3%
1
   5.3%
LAG525 dose reduction, mesothelioma patients Number Analyzed 41 participants 0 participants 16 participants
0
   0.0%
0
   0.0%
LAG525 dose interruption, mesothelioma patients Number Analyzed 41 participants 0 participants 16 participants
8
  19.5%
5
  31.3%
PDR001 dose reduction, mesothelioma patients Number Analyzed 41 participants 0 participants 16 participants
0
   0.0%
0
   0.0%
PDR001 dose interruption, mesothelioma patients Number Analyzed 41 participants 0 participants 16 participants
8
  19.5%
5
  31.3%
LAG525 dose reduction, TNBC patients Number Analyzed 21 participants 21 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
LAG525 dose interruption, TNBC patients Number Analyzed 21 participants 21 participants 14 participants
3
  14.3%
0
   0.0%
0
   0.0%
PDR001 dose reduction, TNBC patients Number Analyzed 21 participants 21 participants 14 participants
0
   0.0%
0
   0.0%
0
   0.0%
PDR001 dose interruption, TNBC patients Number Analyzed 21 participants 21 participants 14 participants
3
  14.3%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Phase 1: Relative Dose Intensity (RDI) of LAG525 and PDR001
Hide Description

Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day).

Japanese patients were not treated with PDR001 and therefore the RDI of this study drug is not applicable.

Time Frame From start of treatment until end of treatment, assessed up to 4.4 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
Arm/Group Title Phase 1: LAG525 1 mg/kg Q2W Phase 1: LAG525 3 mg/kg Q2W Phase 1: LAG525 5 mg/kg Q2W Phase 1: LAG525 10 mg/kg Q2W Phase 1: LAG525 15 mg/kg Q2W Phase 1: LAG525 240 mg Q2W Phase 1: LAG525 400 mg Q2W Phase 1: LAG525 3 mg/kg Q4W Phase 1: LAG525 5 mg/kg Q4W Phase 1: LAG525 10 mg/kg Q4W Phase 1: LAG525 400 mg Q4W Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Hide Arm/Group Description:
Single-agent LAG525 1 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Single-agent LAG525 240 mg Q2W
Single-agent LAG525 400 mg Q2W
Single-agent LAG525 3 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Single-agent LAG525 400 mg Q4W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Overall Number of Participants Analyzed 17 12 6 6 6 30 30 5 6 11 5 6 6 6 5 6 20 6 12 7 6 12 6 11 6 6
Mean (Standard Deviation)
Unit of Measure: percentage
LAG525, ROW patients Number Analyzed 13 participants 12 participants 6 participants 6 participants 6 participants 25 participants 24 participants 5 participants 6 participants 11 participants 5 participants 6 participants 6 participants 6 participants 5 participants 6 participants 20 participants 6 participants 12 participants 7 participants 6 participants 12 participants 6 participants 11 participants 6 participants 6 participants
98.9  (3.93) 100  (0) 94.4  (13.61) 100  (0) 98.2  (4.47) 99.0  (5.00) 99.9  (0.60) 100  (0) 100  (0) 100  (0) 100  (0) 97.4  (6.27) 100  (0) 99.7  (0.84) 100  (0) 99.6  (0.93) 97.8  (5.27) 100  (0) 100  (0) 100  (0) 100  (0) 100  (0) 100  (0) 97.7  (7.54) 100  (0) 100  (0)
PDR001, ROW patients Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 6 participants 6 participants 6 participants 5 participants 6 participants 20 participants 6 participants 12 participants 7 participants 6 participants 12 participants 6 participants 11 participants 6 participants 6 participants
97.3  (6.72) 100  (0) 97.6  (5.00) 100  (0) 100  (0) 98.0  (4.95) 100  (0) 100  (0) 100  (0) 100  (0) 100  (0) 100  (0) 100  (0) 100  (0) 100  (0)
LAG525, Japanese patients Number Analyzed 4 participants 0 participants 0 participants 0 participants 0 participants 5 participants 6 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
100  (0) 98.0  (4.47) 100  (0)
8.Secondary Outcome
Title Phase 2: Relative Dose Intensity (RDI) of LAG525 and PDR001
Hide Description

Relative dose intensity of each study drug is calculated with the following formula: 100 x actual dose intensity (mg/day)/planned dose intensity (mg/day).

The RDI of both study drugs is reported for each tumor type.

Time Frame From start of treatment until end of treatment, assessed up to 2.6 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Arm/Group Title Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Hide Arm/Group Description:
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Overall Number of Participants Analyzed 121 21 93
Mean (Standard Deviation)
Unit of Measure: percentage
LAG525, NSCLC patients Number Analyzed 20 participants 0 participants 22 participants
100  (0) 100  (0)
PDR001, NSCLC patients Number Analyzed 20 participants 0 participants 22 participants
100  (0) 99.8  (0.71)
LAG525, melanoma patients Number Analyzed 20 participants 0 participants 22 participants
99.4  (2.80) 99.7  (1.47)
PDR001, melanoma patients Number Analyzed 20 participants 0 participants 22 participants
99.4  (2.80) 99.7  (1.47)
LAG525, RCC patients Number Analyzed 19 participants 0 participants 19 participants
100  (0) 100  (0)
PDR001, RCC patients Number Analyzed 19 participants 0 participants 19 participants
100  (0) 100  (0)
LAG525, mesothelioma patients Number Analyzed 41 participants 0 participants 16 participants
99.3  (4.26) 99.4  (1.99)
PDR001, mesothelioma patients Number Analyzed 41 participants 0 participants 16 participants
99.3  (4.26) 99.4  (1.99)
LAG525, TNBC patients Number Analyzed 21 participants 21 participants 14 participants
96.5  (11.08) 100  (0) 100  (0)
PDR001, TNBC patients Number Analyzed 21 participants 21 participants 14 participants
98.4  (7.21) 100  (0) 100  (0)
9.Secondary Outcome
Title Phase 1: Maximum Observed Serum Concentration (Cmax) of LAG525
Hide Description Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time Frame pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Arm/Group Title Phase 1: LAG525 1 mg/kg Q2W Phase 1: LAG525 3 mg/kg Q2W Phase 1: LAG525 5 mg/kg Q2W Phase 1: LAG525 10 mg/kg Q2W Phase 1: LAG525 15 mg/kg Q2W Phase 1: LAG525 240 mg Q2W Phase 1: LAG525 400 mg Q2W Phase 1: LAG525 3 mg/kg Q4W Phase 1: LAG525 5 mg/kg Q4W Phase 1: LAG525 10 mg/kg Q4W Phase 1: LAG525 400 mg Q4W Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Hide Arm/Group Description:
Single-agent LAG525 1 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Single-agent LAG525 240 mg Q2W
Single-agent LAG525 400 mg Q2W
Single-agent LAG525 3 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Single-agent LAG525 400 mg Q4W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Overall Number of Participants Analyzed 17 12 6 6 6 29 30 5 6 11 5 6 6 6 5 6 20 5 11 7 4 10 6 11 6 6
Mean (Standard Deviation)
Unit of Measure: ug/mL
Cycle 1, ROW patients Number Analyzed 12 participants 12 participants 6 participants 6 participants 6 participants 24 participants 23 participants 5 participants 6 participants 6 participants 5 participants 6 participants 5 participants 6 participants 4 participants 6 participants 16 participants 3 participants 9 participants 7 participants 3 participants 9 participants 5 participants 9 participants 5 participants 6 participants
21.8  (6.52) 72.4  (14.1) 117  (26.7) 247  (63.2) 393  (95.2) 73.8  (19.2) 116  (28.3) 66.4  (14.1) 118  (23.8) 268  (38.5) 125  (38.9) 8.58  (2.53) 26.5  (3.6) 24.1  (6.58) 25.1  (6.81) 87.9  (24.7) 73.1  (14.7) 122  (36.4) 215  (43.9) 27.2  (5.51) 121  (8.96) 276  (66.5) 303  (82.3) 27.1  (7.56) 86.2  (22.2) 73.1  (42.2)
Cycle 3, ROW patients Number Analyzed 4 participants 7 participants 1 participants 1 participants 3 participants 9 participants 9 participants 3 participants 2 participants 2 participants 2 participants 3 participants 4 participants 3 participants 3 participants 4 participants 14 participants 2 participants 5 participants 3 participants 2 participants 4 participants 2 participants 6 participants 5 participants 3 participants
34.7  (13.2) 124  (30.5) 272 306 607  (108) 114  (36.5) 169  (60.7) 77.9  (11) 117  (26.2) 222  (0) 250  (187) 9.57  (4.91) 31.6  (9.9) 35.2  (7.29) 33.8  (7.75) 156  (70.4) 88.7  (25.3) 114  (19.8) 274  (57.1) 32  (17) 174  (11.3) 354  (118) 513  (72.8) 33.3  (14.5) 96  (42.8) 147  (43)
Cycle 1, Japanese patients Number Analyzed 4 participants 0 participants 0 participants 0 participants 0 participants 4 participants 6 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
23.1  (2.58) 95.5  (18.3) 152  (33.9)
Cycle 3, Japanese patients Number Analyzed 2 participants 0 participants 0 participants 0 participants 0 participants 1 participants 3 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
32.6  (1.2) 198 255  (59.1)
10.Secondary Outcome
Title Phase 2: Maximum Observed Serum Concentration (Cmax) of LAG525
Hide Description Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time Frame pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Arm/Group Title Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Hide Arm/Group Description:
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Overall Number of Participants Analyzed 121 21 92
Mean (Standard Deviation)
Unit of Measure: ug/mL
Cycle 1, NSCLC patients Number Analyzed 20 participants 0 participants 22 participants
154  (43.5) 106  (26.8)
Cycle 3, NSCLC patients Number Analyzed 15 participants 0 participants 15 participants
169  (51.9) 137  (30.8)
Cycle 1, melanoma patients Number Analyzed 20 participants 0 participants 21 participants
115  (29.9) 102  (36.7)
Cycle 3, melanoma patients Number Analyzed 13 participants 0 participants 14 participants
171  (32) 163  (52.8)
Cycle 1, RCC patients Number Analyzed 18 participants 0 participants 16 participants
118  (34.7) 111  (28.3)
Cycle 3, RCC patients Number Analyzed 13 participants 0 participants 11 participants
158  (45.4) 153  (43.5)
Cycle 1, mesothelioma patients Number Analyzed 40 participants 0 participants 15 participants
116  (31) 119  (37.6)
Cycle 3, mesothelioma patients Number Analyzed 32 participants 0 participants 15 participants
141  (39.7) 138  (33.1)
Cycle 1, TNBC patients Number Analyzed 21 participants 21 participants 13 participants
144  (32.4) 207  (53.1) 132  (26.7)
Cycle 3, TNBC patients Number Analyzed 10 participants 4 participants 9 participants
179  (65.2) 190  (55) 157  (33.2)
11.Secondary Outcome
Title Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Hide Description Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Time Frame pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Arm/Group Title Phase 1: LAG525 1 mg/kg Q2W Phase 1: LAG525 3 mg/kg Q2W Phase 1: LAG525 5 mg/kg Q2W Phase 1: LAG525 10 mg/kg Q2W Phase 1: LAG525 15 mg/kg Q2W Phase 1: LAG525 240 mg Q2W Phase 1: LAG525 400 mg Q2W Phase 1: LAG525 3 mg/kg Q4W Phase 1: LAG525 5 mg/kg Q4W Phase 1: LAG525 10 mg/kg Q4W Phase 1: LAG525 400 mg Q4W Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Hide Arm/Group Description:
Single-agent LAG525 1 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Single-agent LAG525 240 mg Q2W
Single-agent LAG525 400 mg Q2W
Single-agent LAG525 3 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Single-agent LAG525 400 mg Q4W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Overall Number of Participants Analyzed 17 12 6 6 6 29 30 5 6 11 5 6 6 6 5 6 20 5 11 7 4 10 6 11 6 6
Median (Full Range)
Unit of Measure: days
Cycle 1, ROW patients Number Analyzed 12 participants 12 participants 6 participants 6 participants 6 participants 24 participants 23 participants 5 participants 6 participants 6 participants 5 participants 6 participants 5 participants 6 participants 4 participants 6 participants 16 participants 3 participants 9 participants 7 participants 3 participants 9 participants 5 participants 9 participants 5 participants 6 participants
1.73
(1.5 to 2.45)
1.6
(1.1 to 2.62)
1.63
(1.17 to 2.13)
1.63
(1.5 to 2.35)
1.99
(1.48 to 2.07)
1.59
(1.5 to 2.17)
1.57
(1.47 to 2.45)
1.58
(1.03 to 2.25)
2.1
(1.5 to 2.17)
2.02
(1.5 to 2.28)
1.5
(1.5 to 1.68)
1.5
(1.5 to 1.65)
1.5
(0.933 to 1.53)
1.5
(1.47 to 1.52)
1.53
(1.5 to 1.58)
1.55
(1.5 to 2.03)
1.52
(1.02 to 4.25)
1.5
(1.5 to 1.58)
1.57
(1 to 4.45)
1.52
(1.5 to 1.55)
1.5
(1.5 to 1.5)
1.58
(1.5 to 2.07)
1.58
(1.5 to 2.1)
1.5
(1.5 to 2.57)
1.7
(1.57 to 2.08)
1.5
(0 to 1.55)
Cycle 3, ROW patients Number Analyzed 4 participants 7 participants 1 participants 1 participants 3 participants 9 participants 9 participants 3 participants 2 participants 2 participants 2 participants 3 participants 4 participants 3 participants 3 participants 4 participants 14 participants 2 participants 5 participants 3 participants 2 participants 4 participants 2 participants 6 participants 5 participants 3 participants
1.83
(1.5 to 2.12)
2.05
(1.55 to 2.08)
1.08
(1.08 to 1.08)
1.55
(1.55 to 1.55)
1.67
(1.67 to 2.08)
1.58
(1.33 to 2.05)
1.5
(1.5 to 2.55)
2.08
(1.52 to 2.12)
1.93
(1.57 to 2.3)
1.83
(1.65 to 2)
1.5
(1.5 to 1.5)
1.72
(1.57 to 1.83)
1.51
(1.5 to 1.57)
1.5
(1.5 to 1.58)
1.5
(1.5 to 1.52)
1.53
(1.5 to 2)
1.53
(1.48 to 3.77)
1.58
(1.58 to 1.58)
1.52
(1 to 1.55)
1.58
(1.5 to 1.75)
1.54
(1.5 to 1.58)
1.58
(1.5 to 2.05)
1.75
(1.5 to 2)
1.53
(1.5 to 2.55)
1.58
(0 to 2)
1.58
(1.57 to 1.58)
Cycle 1, Japanese patients Number Analyzed 4 participants 0 participants 0 participants 0 participants 0 participants 4 participants 6 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
1.58
(1.55 to 1.68)
1.54
(1.5 to 1.63)
1.54
(1.52 to 1.55)
Cycle 3, Japanese patients Number Analyzed 2 participants 0 participants 0 participants 0 participants 0 participants 1 participants 3 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
1.63
(1.58 to 1.68)
1.57
(1.57 to 1.57)
1.6
(1.55 to 1.67)
12.Secondary Outcome
Title Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
Hide Description Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Time Frame pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Arm/Group Title Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Hide Arm/Group Description:
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Overall Number of Participants Analyzed 121 21 92
Median (Full Range)
Unit of Measure: days
Cycle 1, NSCLC patients Number Analyzed 20 participants 0 participants 22 participants
1.53
(0.917 to 3)
1.55
(0.917 to 2.62)
Cycle 3, NSCLC patients Number Analyzed 15 participants 0 participants 15 participants
1.55
(1.45 to 2)
1.58
(1.5 to 2.33)
Cycle 1, melanoma patients Number Analyzed 20 participants 0 participants 21 participants
1.51
(1.43 to 3)
1.53
(1.07 to 2.9)
Cycle 3, melanoma patients Number Analyzed 13 participants 0 participants 14 participants
1.53
(1.45 to 2)
1.53
(0.683 to 1.82)
Cycle 1, RCC patients Number Analyzed 18 participants 0 participants 16 participants
1.51
(1 to 3)
1.53
(1 to 2.05)
Cycle 3, RCC patients Number Analyzed 13 participants 0 participants 11 participants
1.58
(1.48 to 2.08)
1.53
(1.45 to 2.8)
Cycle 1, mesothelioma patients Number Analyzed 40 participants 0 participants 15 participants
1.53
(0.583 to 3)
1.55
(1.47 to 2.08)
Cycle 3, mesothelioma patients Number Analyzed 32 participants 0 participants 15 participants
1.5
(0.967 to 2.13)
1.52
(1.42 to 2.08)
Cycle 1, TNBC patients Number Analyzed 21 participants 21 participants 13 participants
1.53
(0.567 to 3)
1.53
(1.43 to 3)
1.58
(0.95 to 2)
Cycle 3, TNBC patients Number Analyzed 10 participants 4 participants 9 participants
1.63
(1.48 to 2)
1.78
(1.7 to 1.92)
1.6
(1 to 2)
13.Secondary Outcome
Title Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Hide Description Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Time Frame pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Arm/Group Title Phase 1: LAG525 1 mg/kg Q2W Phase 1: LAG525 3 mg/kg Q2W Phase 1: LAG525 5 mg/kg Q2W Phase 1: LAG525 10 mg/kg Q2W Phase 1: LAG525 15 mg/kg Q2W Phase 1: LAG525 240 mg Q2W Phase 1: LAG525 400 mg Q2W Phase 1: LAG525 3 mg/kg Q4W Phase 1: LAG525 5 mg/kg Q4W Phase 1: LAG525 10 mg/kg Q4W Phase 1: LAG525 400 mg Q4W Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Hide Arm/Group Description:
Single-agent LAG525 1 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Single-agent LAG525 240 mg Q2W
Single-agent LAG525 400 mg Q2W
Single-agent LAG525 3 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Single-agent LAG525 400 mg Q4W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Overall Number of Participants Analyzed 17 12 6 6 6 29 30 5 6 11 5 6 6 6 5 6 20 5 11 7 4 10 6 11 6 6
Mean (Standard Deviation)
Unit of Measure: day*ug/mL
Cycle 1, ROW patients Number Analyzed 13 participants 12 participants 6 participants 6 participants 6 participants 25 participants 24 participants 5 participants 6 participants 10 participants 5 participants 6 participants 6 participants 6 participants 5 participants 6 participants 19 participants 4 participants 9 participants 7 participants 3 participants 10 participants 6 participants 11 participants 6 participants 5 participants
136  (49.2) 506  (111) 758  (172) 1830  (627) 2810  (555) 500  (147) 708  (199) 631  (184) 1220  (491) 2230  (731) 1290  (537) 35.8  (10.5) 174  (31.3) 138  (38.9) 162  (56.5) 588  (196) 608  (165) 952  (441) 1640  (539) 198  (101) 1040  (183) 2890  (982) 3020  (928) 150  (61.6) 484  (173) 551  (205)
Cycle 3, ROW patients Number Analyzed 4 participants 7 participants 1 participants 1 participants 4 participants 11 participants 9 participants 3 participants 3 participants 2 participants 2 participants 3 participants 5 participants 3 participants 3 participants 4 participants 14 participants 3 participants 6 participants 3 participants 2 participants 4 participants 2 participants 7 participants 4 participants 5 participants
264  (146) 1000  (358) 2470 2330 5270  (1250) 862  (583) 1390  (759) 928  (469) 1200  (754) 1770  (2230) 2740  (2680) 59.9  (39.3) 286  (134) 264  (133) 234  (108) 1310  (701) 869  (328) 1410  (831) 1990  (1180) 336  (439) 2250  (44.7) 3840  (1600) 7160  (3190) 211  (150) 938  (141) 1230  (617)
Cycle 1, Japanese patients Number Analyzed 4 participants 0 participants 0 participants 0 participants 0 participants 4 participants 6 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
144  (35.6) 679  (142) 1130  (153)
Cycle 3, Japanese patients Number Analyzed 3 participants 0 participants 0 participants 0 participants 0 participants 1 participants 3 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
89.6  (76.7) 1720 2520  (359)
14.Secondary Outcome
Title Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
Hide Description Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.
Time Frame pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 2 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Arm/Group Title Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Hide Arm/Group Description:
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Overall Number of Participants Analyzed 121 21 92
Mean (Standard Deviation)
Unit of Measure: day*ug/mL
Cycle 1, NSCLC patients Number Analyzed 20 participants 0 participants 22 participants
1260  (509) 955  (272)
Cycle 3, NSCLC patients Number Analyzed 16 participants 0 participants 16 participants
1500  (688) 1260  (554)
Cycle 1, melanoma patients Number Analyzed 20 participants 0 participants 22 participants
1030  (404) 953  (340)
Cycle 3, melanoma patients Number Analyzed 13 participants 0 participants 16 participants
1860  (507) 1680  (754)
Cycle 1, RCC patients Number Analyzed 19 participants 0 participants 17 participants
979  (366) 886  (429)
Cycle 3, RCC patients Number Analyzed 14 participants 0 participants 13 participants
1420  (678) 1280  (809)
Cycle 1, mesothelioma patients Number Analyzed 41 participants 0 participants 16 participants
963  (329) 1070  (350)
Cycle 3, mesothelioma patients Number Analyzed 34 participants 0 participants 16 participants
1400  (732) 1380  (729)
Cycle 1, TNBC patients Number Analyzed 21 participants 21 participants 14 participants
1180  (379) 2010  (807) 1150  (234)
Cycle 3, TNBC patients Number Analyzed 11 participants 7 participants 9 participants
1710  (1090) 2800  (1210) 1530  (578)
15.Secondary Outcome
Title Phase 1: Terminal Elimination Half-life (T1/2) of LAG525
Hide Description Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
Time Frame pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
Arm/Group Title Phase 1: LAG525 1 mg/kg Q2W Phase 1: LAG525 3 mg/kg Q2W Phase 1: LAG525 5 mg/kg Q2W Phase 1: LAG525 10 mg/kg Q2W Phase 1: LAG525 15 mg/kg Q2W Phase 1: LAG525 240 mg Q2W Phase 1: LAG525 400 mg Q2W Phase 1: LAG525 3 mg/kg Q4W Phase 1: LAG525 5 mg/kg Q4W Phase 1: LAG525 10 mg/kg Q4W Phase 1: LAG525 400 mg Q4W Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Hide Arm/Group Description:
Single-agent LAG525 1 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Single-agent LAG525 240 mg Q2W
Single-agent LAG525 400 mg Q2W
Single-agent LAG525 3 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Single-agent LAG525 400 mg Q4W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Overall Number of Participants Analyzed 17 12 6 6 6 29 30 5 6 11 5 6 6 6 5 6 20 5 11 7 4 10 6 11 6 6
Mean (Standard Deviation)
Unit of Measure: days
Cycle 1, ROW patients Number Analyzed 11 participants 12 participants 6 participants 6 participants 6 participants 21 participants 19 participants 5 participants 6 participants 9 participants 5 participants 4 participants 6 participants 6 participants 5 participants 6 participants 18 participants 4 participants 9 participants 7 participants 3 participants 9 participants 6 participants 11 participants 5 participants 5 participants
7.65  (1.94) 11.1  (4.12) 9.99  (2.37) 12  (4.5) 12.8  (8) 10.3  (3.5) 11.5  (6.59) 13.5  (4.07) 13.1  (5.38) 13.9  (5.15) 13.6  (7.61) 3.47  (1.4) 9.15  (3.86) 6.5  (3.25) 7.52  (2.5) 9.5  (2.78) 11.5  (3.7) 11.3  (4.94) 10.2  (3.68) 7.49  (4.42) 15.7  (4.23) 17.9  (7.88) 14.4  (3.28) 5.26  (2.43) 9.12  (2.07) 9.36  (2.18)
Cycle 3, ROW patients Number Analyzed 3 participants 6 participants 1 participants 1 participants 3 participants 7 participants 8 participants 2 participants 2 participants 1 participants 2 participants 3 participants 5 participants 3 participants 2 participants 1 participants 14 participants 2 participants 5 participants 2 participants 2 participants 3 participants 2 participants 6 participants 4 participants 4 participants
11.2  (2.62) 14.4  (5.82) 5.94 12.2 16.5  (2.87) 12.1  (5.06) 18  (9.7) 15  (2.36) 20.6  (8.51) 20.8 23.4  (14.6) 6.15  (2.98) 9.55  (3.95) 9.17  (4.36) 13.1  (0.736) 14.7 14.3  (7.02) 14.5  (1.24) 13.8  (4.45) 11.1  (10.9) 18.3  (3.58) 15.1  (5.44) 26.3  (11.9) 7.32  (4.94) 10.8  (1.76) 15.1  (4.54)
Cycle 1, Japanese patients Number Analyzed 4 participants 0 participants 0 participants 0 participants 0 participants 4 participants 6 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
13.7  (10.2) 9.42  (2.27) 13.8  (4.38)
Cycle 3, Japanese patients Number Analyzed 2 participants 0 participants 0 participants 0 participants 0 participants 1 participants 3 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
5.49  (2.38) 19.4 28.1  (18)
16.Secondary Outcome
Title Phase 2: Terminal Elimination Half-life (T1/2) of LAG525
Hide Description Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Elimination half-life (T1/2) values were calculated as 0.693/terminal elimination rate constant.
Time Frame pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 2 who received at least one full or partial dose of LAG525 and had a valid measure of the endpoint.
Arm/Group Title Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Hide Arm/Group Description:
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Overall Number of Participants Analyzed 84 13 64
Mean (Standard Deviation)
Unit of Measure: days
Cycle 1, NSCLC patients Number Analyzed 17 participants 0 participants 13 participants
11.6  (6.11) 13.3  (4.62)
Cycle 3, NSCLC patients Number Analyzed 9 participants 0 participants 9 participants
16.3  (9.17) 15.9  (7.88)
Cycle 1, melanoma patients Number Analyzed 12 participants 0 participants 15 participants
15.6  (5.18) 15.5  (5.92)
Cycle 3, melanoma patients Number Analyzed 9 participants 0 participants 6 participants
20.1  (5.24) 19.2  (9.26)
Cycle 1, RCC patients Number Analyzed 13 participants 0 participants 11 participants
14.2  (3.61) 14.1  (5.39)
Cycle 3, RCC patients Number Analyzed 8 participants 0 participants 3 participants
14.1  (3.71) 23.1  (6.33)
Cycle 1, mesothelioma patients Number Analyzed 29 participants 0 participants 11 participants
13  (5.13) 13.7  (5.27)
Cycle 3, mesothelioma patients Number Analyzed 16 participants 0 participants 8 participants
18.4  (7.16) 18.7  (5.47)
Cycle 1, TNBC patients Number Analyzed 8 participants 13 participants 7 participants
22.5  (18.9) 14.6  (3.82) 14.4  (5.01)
Cycle 3, TNBC patients Number Analyzed 6 participants 0 participants 4 participants
18.7  (9.14) 19  (4.78)
17.Secondary Outcome
Title Phase 1: Maximum Observed Serum Concentration (Cmax) of PDR001
Hide Description

Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.

Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.

Time Frame pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
Arm/Group Title Phase 1: LAG525 1 mg/kg Q2W Phase 1: LAG525 3 mg/kg Q2W Phase 1: LAG525 5 mg/kg Q2W Phase 1: LAG525 10 mg/kg Q2W Phase 1: LAG525 15 mg/kg Q2W Phase 1: LAG525 240 mg Q2W Phase 1: LAG525 400 mg Q2W Phase 1: LAG525 3 mg/kg Q4W Phase 1: LAG525 5 mg/kg Q4W Phase 1: LAG525 10 mg/kg Q4W Phase 1: LAG525 400 mg Q4W Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Hide Arm/Group Description:
Single-agent LAG525 1 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Single-agent LAG525 240 mg Q2W
Single-agent LAG525 400 mg Q2W
Single-agent LAG525 3 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Single-agent LAG525 400 mg Q4W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0 0 6 6 6 5 6 20 5 11 7 4 10 6 11 6 6
Mean (Standard Deviation)
Unit of Measure: ug/mL
Cycle 1, ROW patients Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 5 participants 5 participants 6 participants 5 participants 6 participants 14 participants 4 participants 11 participants 7 participants 4 participants 8 participants 5 participants 9 participants 5 participants 6 participants
19.6  (3.59) 19.6  (2.77) 17.7  (3.84) 58.8  (23.2) 67.9  (20.4) 76.2  (20) 61.5  (22.1) 85.1  (28) 65  (11.3) 87.6  (24.5) 113  (26.8) 116  (28.1) 100  (23.1) 115  (33.2) 97.9  (17)
Cycle 3, ROW patients Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 4 participants 2 participants 3 participants 3 participants 8 participants 3 participants 7 participants 2 participants 1 participants 3 participants 2 participants 5 participants 5 participants 3 participants
30.4  (11.9) 28.7  (8.4) 29.7  (9.97) 89.5  (28.9) 168  (20.1) 97.5  (34.4) 80  (25.1) 123  (35.6) 90.8  (51.2) 142 134  (56.7) 167  (9.9) 141  (58.2) 147  (29.8) 126  (27.2)
18.Secondary Outcome
Title Phase 2: Maximum Observed Serum Concentration (Cmax) of PDR001
Hide Description Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.
Time Frame pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
Arm/Group Title Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Hide Arm/Group Description:
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Overall Number of Participants Analyzed 121 21 92
Mean (Standard Deviation)
Unit of Measure: ug/mL
Cycle 1, NSCLC patients Number Analyzed 20 participants 0 participants 20 participants
102  (33) 68.9  (17.3)
Cycle 3, NSCLC patients Number Analyzed 16 participants 0 participants 13 participants
118  (36.5) 100  (24.2)
Cycle 1, melanoma patients Number Analyzed 19 participants 0 participants 20 participants
75.7  (25.2) 71.3  (26.2)
Cycle 3, melanoma patients Number Analyzed 13 participants 0 participants 14 participants
117  (29.8) 105  (43.3)
Cycle 1, RCC patients Number Analyzed 18 participants 0 participants 15 participants
81  (21.3) 67  (25.8)
Cycle 3, RCC patients Number Analyzed 13 participants 0 participants 13 participants
104  (23.8) 103  (36.1)
Cycle 1, mesothelioma patients Number Analyzed 35 participants 0 participants 16 participants
70.5  (21.4) 82.7  (39)
Cycle 3, mesothelioma patients Number Analyzed 33 participants 0 participants 16 participants
96.5  (31.5) 113  (36.8)
Cycle 1, TNBC patients Number Analyzed 20 participants 19 participants 13 participants
91.5  (25.1) 117  (36.7) 89.8  (14.8)
Cycle 3, TNBC patients Number Analyzed 11 participants 5 participants 9 participants
124  (36.5) 134  (54) 123  (18.5)
19.Secondary Outcome
Title Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Hide Description

Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.

Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.

Time Frame pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 1 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
Arm/Group Title Phase 1: LAG525 1 mg/kg Q2W Phase 1: LAG525 3 mg/kg Q2W Phase 1: LAG525 5 mg/kg Q2W Phase 1: LAG525 10 mg/kg Q2W Phase 1: LAG525 15 mg/kg Q2W Phase 1: LAG525 240 mg Q2W Phase 1: LAG525 400 mg Q2W Phase 1: LAG525 3 mg/kg Q4W Phase 1: LAG525 5 mg/kg Q4W Phase 1: LAG525 10 mg/kg Q4W Phase 1: LAG525 400 mg Q4W Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Hide Arm/Group Description:
Single-agent LAG525 1 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Single-agent LAG525 240 mg Q2W
Single-agent LAG525 400 mg Q2W
Single-agent LAG525 3 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Single-agent LAG525 400 mg Q4W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0 0 6 6 6 5 6 20 5 11 7 4 10 6 11 6 6
Median (Full Range)
Unit of Measure: days
Cycle 1, ROW patients Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 5 participants 5 participants 6 participants 5 participants 6 participants 14 participants 4 participants 11 participants 7 participants 4 participants 8 participants 5 participants 9 participants 5 participants 6 participants
1.5
(1.47 to 1.62)
1.5
(1.1 to 1.55)
1.55
(1.42 to 1.63)
1.63
(1.52 to 1.78)
1.51
(0.95 to 1.67)
1.53
(0.467 to 2.42)
1.75
(1.5 to 2.08)
1.53
(1.45 to 2.5)
1.58
(1.5 to 2.02)
1.5
(1.47 to 1.72)
1.66
(1.5 to 2.07)
1.5
(0.583 to 1.58)
1.5
(1.5 to 1.58)
1.58
(0.683 to 2.12)
1.56
(1.47 to 1.68)
Cycle 3, ROW patients Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 4 participants 2 participants 3 participants 3 participants 8 participants 3 participants 7 participants 2 participants 1 participants 3 participants 2 participants 5 participants 5 participants 3 participants
1.5
(1.07 to 1.65)
1.58
(1.57 to 1.68)
1.55
(1.52 to 1.58)
1.72
(1.57 to 17.2)
1.75
(1.58 to 2.08)
1.5
(0.45 to 1.72)
1.5
(1.5 to 1.62)
1.58
(1 to 2.13)
1.63
(1.58 to 1.67)
1.8
(1.8 to 1.8)
1.53
(1.45 to 2.08)
1.87
(1.57 to 2.17)
1.55
(1.52 to 1.6)
1.55
(0.533 to 2.12)
1.58
(1.52 to 1.68)
20.Secondary Outcome
Title Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of PDR001
Hide Description Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
Time Frame pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 21 days (Q3W) and 28 days (Q4W).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in phase 2 who received at least one full or partial dose of PDR001 and who had at least one serum sample providing evaluable PK data.
Arm/Group Title Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Hide Arm/Group Description:
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Overall Number of Participants Analyzed 121 21 92
Median (Full Range)
Unit of Measure: days
Cycle 1, NSCLC patients Number Analyzed 20 participants 0 participants 20 participants
1.57
(1.52 to 3)
1.57
(1 to 2.12)
Cycle 3, NSCLC patients Number Analyzed 16 participants 0 participants 13 participants
1.57
(1.32 to 2.08)
1.58
(1.47 to 2.08)
Cycle 1, melanoma patients Number Analyzed 19 participants 0 participants 20 participants
1.55
(0.35 to 3.08)
1.53
(0.567 to 2.5)
Cycle 3, melanoma patients Number Analyzed 13 participants 0 participants 14 participants
1.57
(1.08 to 2.08)
1.53
(0.583 to 1.63)
Cycle 1, RCC patients Number Analyzed 18 participants 0 participants 15 participants
1.58
(1 to 3.08)
1.57
(0.55 to 2)
Cycle 3, RCC patients Number Analyzed 13 participants 0 participants 13 participants
1.53
(1.5 to 2.08)
1.58
(1.47 to 2)
Cycle 1, mesothelioma patients Number Analyzed 35 participants 0 participants 16 participants
1.55
(0.483 to 3)
1.54
(0.5 to 2)
Cycle 3, mesothelioma patients Number Analyzed 33 participants 0 participants 16 participants
1.52
(0.1 to 2.05)
1.5
(0.283 to 2.08)
Cycle 1, TNBC patients Number Analyzed 20 participants 19 participants 13 participants
1.58
(0.5 to 3)
1.57
(1.45 to 2.92)
1.53
(0.967 to 2.08)
Cycle 3, TNBC patients Number Analyzed 11 participants 5 participants 9 participants
1.6
(1.48 to 2.5)
1.75
(1.6 to 2.43)
1.65
(1.5 to 2.42)
21.Secondary Outcome
Title Phase 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PDR001
Hide Description

Pharmacokinetic (PK) parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC calculation.

Japanese patients were not treated with PDR001 and therefore the PK parameters of this study drug are not applicable.

Time Frame pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).