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NCT02460224 · OUTCOME

Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525

Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. · Source last updated 2022-02-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
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).

What was measured

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.

Analysis population: 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.

Groups in this outcome

Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1

Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W

Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1

Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W121
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W21
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W92

Reported measurements

Cycle 1, NSCLC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W20
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W22
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.53Not reported0.9173Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.55Not reported0.9172.62Not reported
Cycle 3, NSCLC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W15
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W15
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.55Not reported1.452Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.58Not reported1.52.33Not reported
Cycle 1, melanoma patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W20
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W21
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.51Not reported1.433Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.53Not reported1.072.9Not reported
Cycle 3, melanoma patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W13
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W14
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.53Not reported1.452Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.53Not reported0.6831.82Not reported
Cycle 1, RCC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W18
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W16
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.51Not reported13Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.53Not reported12.05Not reported
Cycle 3, RCC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W13
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W11
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.58Not reported1.482.08Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.53Not reported1.452.8Not reported
Cycle 1, mesothelioma patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W40
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W15
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.53Not reported0.5833Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.55Not reported1.472.08Not reported
Cycle 3, mesothelioma patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W32
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W15
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.5Not reported0.9672.13Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.52Not reported1.422.08Not reported
Cycle 1, TNBC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W21
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W21
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W13
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.53Not reported0.5673Not reported
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W1.53Not reported1.433Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.58Not reported0.952Not reported
Cycle 3, TNBC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W10
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W4
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W9
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.63Not reported1.482Not reported
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W1.78Not reported1.71.92Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.6Not reported12Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.917
        upper Limit
        3
        value
        1.53
      2. group Id
        OG002
        lower Limit
        0.917
        upper Limit
        2.62
        value
        1.55
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        22
      units
      Participants
    title
    Cycle 1, NSCLC patients
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        2
        value
        1.55
      2. group Id
        OG002
        lower Limit
        1.5
        upper Limit
        2.33
        value
        1.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        15
      units
      Participants
    title
    Cycle 3, NSCLC patients
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.43
        upper Limit
        3
        value
        1.51
      2. group Id
        OG002
        lower Limit
        1.07
        upper Limit
        2.9
        value
        1.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        21
      units
      Participants
    title
    Cycle 1, melanoma patients
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.45
        upper Limit
        2
        value
        1.53
      2. group Id
        OG002
        lower Limit
        0.683
        upper Limit
        1.82
        value
        1.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        14
      units
      Participants
    title
    Cycle 3, melanoma patients
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        3
        value
        1.51
      2. group Id
        OG002
        lower Limit
        1
        upper Limit
        2.05
        value
        1.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        16
      units
      Participants
    title
    Cycle 1, RCC patients
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.48
        upper Limit
        2.08
        value
        1.58
      2. group Id
        OG002
        lower Limit
        1.45
        upper Limit
        2.8
        value
        1.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    Cycle 3, RCC patients
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.583
        upper Limit
        3
        value
        1.53
      2. group Id
        OG002
        lower Limit
        1.47
        upper Limit
        2.08
        value
        1.55
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        15
      units
      Participants
    title
    Cycle 1, mesothelioma patients
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.967
        upper Limit
        2.13
        value
        1.5
      2. group Id
        OG002
        lower Limit
        1.42
        upper Limit
        2.08
        value
        1.52
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        15
      units
      Participants
    title
    Cycle 3, mesothelioma patients
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.567
        upper Limit
        3
        value
        1.53
      2. group Id
        OG001
        lower Limit
        1.43
        upper Limit
        3
        value
        1.53
      3. group Id
        OG002
        lower Limit
        0.95
        upper Limit
        2
        value
        1.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        13
      units
      Participants
    title
    Cycle 1, TNBC patients
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.48
        upper Limit
        2
        value
        1.63
      2. group Id
        OG001
        lower Limit
        1.7
        upper Limit
        1.92
        value
        1.78
      3. group Id
        OG002
        lower Limit
        1
        upper Limit
        2
        value
        1.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        9
      units
      Participants
    title
    Cycle 3, TNBC patients
denoms
  1. counts
    1. group Id
      OG000
      value
      121
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      92
    units
    Participants
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.
dispersion Type
Full Range
groups
  1. description
    Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
    id
    OG000
    title
    Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W
  2. description
    Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
    id
    OG001
    title
    Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W
  3. description
    Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
    id
    OG002
    title
    Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
param Type
MEDIAN
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.
reporting Status
POSTED
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).
title
Phase 2: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
type
SECONDARY
unit Of Measure
days

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Preserved source evidence · Not medical advice