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NCT02142738 · OUTCOME

Progression Free Survival (PFS) Rate at Month 6

Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024) · Source last updated 2022-06-13

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
Month 6

What was measured

PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment. The data cutoff was 09-May-2016. The PFS rate at Month 6 was calculated.

Analysis population: The Intention-to-treat (ITT) population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.

Groups in this outcome

Pembrolizumab

Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.

SOC Chemotherapy

Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab154
SOC Chemotherapy151

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab62.1Not reported53.869.4Not reported
SOC Chemotherapy50.3Not reported41.958.2Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.68
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.001
    p Value Comment
    One-sided p-value based on log-rank test
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Comment
    Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.68
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.001
    p Value Comment
    One-sided p-value based on log-rank test
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Comment
    Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        53.8
        upper Limit
        69.4
        value
        62.1
      2. group Id
        OG001
        lower Limit
        41.9
        upper Limit
        58.2
        value
        50.3
denoms
  1. counts
    1. group Id
      OG000
      value
      154
    2. group Id
      OG001
      value
      151
    units
    Participants
description
PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment. The data cutoff was 09-May-2016. The PFS rate at Month 6 was calculated.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
    id
    OG000
    title
    Pembrolizumab
  2. description
    Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
    id
    OG001
    title
    SOC Chemotherapy
param Type
NUMBER
population Description
The Intention-to-treat (ITT) population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.
reporting Status
POSTED
time Frame
Month 6
title
Progression Free Survival (PFS) Rate at Month 6
type
PRIMARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice