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NCT02494583 · OUTCOME

Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥1 (All Participants)

Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062) · Source last updated 2023-04-13

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 42 months

What was measured

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.

Analysis population: All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.

Groups in this outcome

Pembrolizumab Monotherapy (Pembro Mono)

Participants received pembrolizumab 200 mg IV Q3W.

Pembrolizumab + SOC Chemotherapy (Pembro Combo)

Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.

Placebo + SOC Chemotherapy (SOC)

Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.

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 Monotherapy (Pembro Mono)256
Pembrolizumab + SOC Chemotherapy (Pembro Combo)0
Placebo + SOC Chemotherapy (SOC)250

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab Monotherapy (Pembro Mono)10.6Not reported7.713.8Not reported
Placebo + SOC Chemotherapy (SOC)11.1Not reported9.212.8Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99.2
    ci Upper Limit
    1.18
    estimate Comment
    Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
    group Description
    OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fourth primary hypothesis (non-inferiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    Pre-specified non-inferiority margin: if the upper bound of the confidence interval (based on the alpha level allocated to the analysis) for the hazard ratio (\[HR\], pembro mono arm vs SOC) is \< 1.2, the pembro mono arm could be considered as non-inferior to the SOC arm in terms of OS.
    non Inferiority Type
    NON_INFERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.91
  2. ci Lower Limit
    0.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.10
    estimate Comment
    Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
    group Description
    OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fifth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.16205
    p Value Comment
    One-sided p-value based on log-rank test with stratification.
    param Type
    Hazard Ratio (HR)
    param Value
    0.91
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99.2
    ci Upper Limit
    1.18
    estimate Comment
    Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
    group Description
    OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fourth primary hypothesis (non-inferiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    Pre-specified non-inferiority margin: if the upper bound of the confidence interval (based on the alpha level allocated to the analysis) for the hazard ratio (\[HR\], pembro mono arm vs SOC) is \< 1.2, the pembro mono arm could be considered as non-inferior to the SOC arm in terms of OS.
    non Inferiority Type
    NON_INFERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.91
  2. ci Lower Limit
    0.74
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.10
    estimate Comment
    Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
    group Description
    OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fifth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.16205
    p Value Comment
    One-sided p-value based on log-rank test with stratification.
    param Type
    Hazard Ratio (HR)
    param Value
    0.91
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.7
        upper Limit
        13.8
        value
        10.6
      2. group Id
        OG002
        lower Limit
        9.2
        upper Limit
        12.8
        value
        11.1
denoms
  1. counts
    1. group Id
      OG000
      value
      256
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      250
    units
    Participants
description
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg IV Q3W.
    id
    OG000
    title
    Pembrolizumab Monotherapy (Pembro Mono)
  2. description
    Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
    id
    OG001
    title
    Pembrolizumab + SOC Chemotherapy (Pembro Combo)
  3. description
    Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
    id
    OG002
    title
    Placebo + SOC Chemotherapy (SOC)
param Type
MEDIAN
population Description
All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
reporting Status
POSTED
time Frame
Up to approximately 42 months
title
Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥1 (All Participants)
type
PRIMARY
unit Of Measure
Months

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