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NCT02578680 · OUTCOME

Progression-Free Survival (PFS) as Assessed by Investigator Immune-related RECIST (irRECIST) Response Criteria

Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189) · Source last updated 2024-09-20

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 39 months

What was measured

PFS was defined as the time from randomization to the first documented immune-related progressive disease (irPD) or death due to any cause, whichever occurred first. Per irRECIST, irPD was confirmed if any of the following are observed in 2 scans performed at least 4 weeks apart: target lesion sum of diameters remains ≥20 % and at least 5 mm absolute increase compared to nadir; non-target disease resulting in initial PD is qualitatively worse; new lesion resulting in initial irPD is qualitatively worse; additional new lesion(s) since last evaluation; or additional new non-target lesion progression since last evaluation. The PFS per irRECIST 1.1 is presented.

Analysis population: The analysis population consisted of all randomized participants.

Groups in this outcome

Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed

Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)

Control

Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed410
Control206

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed10.3Not reported9.011.3Not reported
Control5.0Not reported4.86.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.59
    estimate Comment
    Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.00001
    param Type
    Hazard Ratio (HR)
    param Value
    0.49
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.59
    estimate Comment
    Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.00001
    param Type
    Hazard Ratio (HR)
    param Value
    0.49
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.0
        upper Limit
        11.3
        value
        10.3
      2. group Id
        OG001
        lower Limit
        4.8
        upper Limit
        6.0
        value
        5.0
denoms
  1. counts
    1. group Id
      OG000
      value
      410
    2. group Id
      OG001
      value
      206
    units
    Participants
description
PFS was defined as the time from randomization to the first documented immune-related progressive disease (irPD) or death due to any cause, whichever occurred first. Per irRECIST, irPD was confirmed if any of the following are observed in 2 scans performed at least 4 weeks apart: target lesion sum of diameters remains ≥20 % and at least 5 mm absolute increase compared to nadir; non-target disease resulting in initial PD is qualitatively worse; new lesion resulting in initial irPD is qualitatively worse; additional new lesion(s) since last evaluation; or additional new non-target lesion progression since last evaluation. The PFS per irRECIST 1.1 is presented.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)
    id
    OG000
    title
    Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed
  2. description
    Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)
    id
    OG001
    title
    Control
param Type
MEDIAN
population Description
The analysis population consisted of all randomized participants.
reporting Status
POSTED
time Frame
Up to approximately 39 months
title
Progression-Free Survival (PFS) as Assessed by Investigator Immune-related RECIST (irRECIST) Response Criteria
type
OTHER_PRE_SPECIFIED
unit Of Measure
Months

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Preserved source evidence · Not medical advice