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NCT02460224 · OUTCOME

Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) 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
MEAN
Unit
day*ug/mL
Interval / dispersion
Standard Deviation
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. The linear trapezoidal method was used for AUC calculation.

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 day*ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1260509Not reportedNot reportedNot reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W955272Not reportedNot reportedNot reported
Cycle 3, NSCLC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W16
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 day*ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1500688Not reportedNot reportedNot reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1260554Not reportedNot reportedNot 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 Q3W22
Values in day*ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1030404Not reportedNot reportedNot reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W953340Not reportedNot reportedNot 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 Q3W16
Values in day*ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1860507Not reportedNot reportedNot reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1680754Not reportedNot reportedNot reported
Cycle 1, RCC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W19
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W17
Values in day*ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W979366Not reportedNot reportedNot reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W886429Not reportedNot reportedNot reported
Cycle 3, RCC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W14
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W13
Values in day*ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1420678Not reportedNot reportedNot reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1280809Not reportedNot reportedNot reported
Cycle 1, mesothelioma patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W41
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 day*ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W963329Not reportedNot reportedNot reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1070350Not reportedNot reportedNot reported
Cycle 3, mesothelioma patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W34
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 day*ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1400732Not reportedNot reportedNot reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1380729Not reportedNot reportedNot 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 Q3W14
Values in day*ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1180379Not reportedNot reportedNot reported
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W2010807Not reportedNot reportedNot reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1150234Not reportedNot reportedNot reported
Cycle 3, TNBC patients

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W11
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W7
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W9
Values in day*ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W17101090Not reportedNot reportedNot reported
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W28001210Not reportedNot reportedNot reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1530578Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        509
        value
        1260
      2. group Id
        OG002
        spread
        272
        value
        955
    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
        spread
        688
        value
        1500
      2. group Id
        OG002
        spread
        554
        value
        1260
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        16
      units
      Participants
    title
    Cycle 3, NSCLC patients
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        404
        value
        1030
      2. group Id
        OG002
        spread
        340
        value
        953
    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, melanoma patients
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        507
        value
        1860
      2. group Id
        OG002
        spread
        754
        value
        1680
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        16
      units
      Participants
    title
    Cycle 3, melanoma patients
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        366
        value
        979
      2. group Id
        OG002
        spread
        429
        value
        886
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        17
      units
      Participants
    title
    Cycle 1, RCC patients
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        678
        value
        1420
      2. group Id
        OG002
        spread
        809
        value
        1280
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        13
      units
      Participants
    title
    Cycle 3, RCC patients
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        329
        value
        963
      2. group Id
        OG002
        spread
        350
        value
        1070
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        16
      units
      Participants
    title
    Cycle 1, mesothelioma patients
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        732
        value
        1400
      2. group Id
        OG002
        spread
        729
        value
        1380
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        16
      units
      Participants
    title
    Cycle 3, mesothelioma patients
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        379
        value
        1180
      2. group Id
        OG001
        spread
        807
        value
        2010
      3. group Id
        OG002
        spread
        234
        value
        1150
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        14
      units
      Participants
    title
    Cycle 1, TNBC patients
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        1090
        value
        1710
      2. group Id
        OG001
        spread
        1210
        value
        2800
      3. group Id
        OG002
        spread
        578
        value
        1530
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        7
      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. The linear trapezoidal method was used for AUC calculation.
dispersion Type
Standard Deviation
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
MEAN
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: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LAG525
type
SECONDARY
unit Of Measure
day*ug/mL

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Preserved source evidence · Not medical advice