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NCT02555657 · OUTCOME

Overall Survival in Participants With PD-L1 CPS ≥1

Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119) · Source last updated 2021-12-10

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 36 months (through Final Analysis database cutoff date of 11-April-2019)

What was measured

Overall survival (OS) was defined as the time from randomization to death due to any cause.

Analysis population: All participants with PD-L1 CPS ≥1 who were included in a treatment group at randomization

Groups in this outcome

Pembrolizumab

Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to \~2 years).

Chemotherapy

Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and 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
Pembrolizumab203
Chemotherapy202

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab10.7Not reported9.312.5Not reported
Chemotherapy10.2Not reported7.912.6Not 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
    95
    ci Upper Limit
    1.06
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0728
    param Type
    Hazard Ratio (HR)
    param Value
    0.86
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.06
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0728
    param Type
    Hazard Ratio (HR)
    param Value
    0.86
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.3
        upper Limit
        12.5
        value
        10.7
      2. group Id
        OG001
        lower Limit
        7.9
        upper Limit
        12.6
        value
        10.2
denoms
  1. counts
    1. group Id
      OG000
      value
      203
    2. group Id
      OG001
      value
      202
    units
    Participants
description
Overall survival (OS) was defined as the time from randomization to death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to \~2 years).
    id
    OG000
    title
    Pembrolizumab
  2. description
    Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.
    id
    OG001
    title
    Chemotherapy
param Type
MEDIAN
population Description
All participants with PD-L1 CPS ≥1 who were included in a treatment group at randomization
reporting Status
POSTED
time Frame
Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)
title
Overall Survival in Participants With PD-L1 CPS ≥1
type
PRIMARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice