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NCT02494583 · OUTCOME

Pembro Combo vs SOC: Objective Response Rate (ORR) Per RECIST 1.1 by BICR 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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 42 months

What was measured

ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro combo arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record.

Analysis population: All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono 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)0
Pembrolizumab + SOC Chemotherapy (Pembro Combo)257
Placebo + SOC Chemotherapy (SOC)250

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab + SOC Chemotherapy (Pembro Combo)48.6Not reported42.454.9Not reported
Placebo + SOC Chemotherapy (SOC)37.2Not reported31.243.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    2.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    20.0
    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
    ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen \& Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    OTHER
    p Value
    0.00447
    p Value Comment
    No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
    param Type
    Difference in ORR Percentage
    param Value
    11.5
    statistical Method
    Miettinen & Nurminen method
Complete source fields
analyses
  1. ci Lower Limit
    2.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    20.0
    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
    ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen \& Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    OTHER
    p Value
    0.00447
    p Value Comment
    No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
    param Type
    Difference in ORR Percentage
    param Value
    11.5
    statistical Method
    Miettinen & Nurminen method
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        42.4
        upper Limit
        54.9
        value
        48.6
      2. group Id
        OG002
        lower Limit
        31.2
        upper Limit
        43.5
        value
        37.2
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      257
    3. group Id
      OG002
      value
      250
    units
    Participants
description
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro combo arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later 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
NUMBER
population Description
All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono 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 Combo vs SOC: Objective Response Rate (ORR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice