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NCT02555657 · OUTCOME

Disease Control Rate Per RECIST 1.1 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
NUMBER
Unit
Percentage of participants
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

Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.\])

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 Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab14.3Not reported9.819.9Not reported
Chemotherapy15.8Not reported11.121.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -8.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.5
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6701
    param Type
    Difference in percentages
    param Value
    -1.6
    statistical Method
    Miettinen & Nurminen method
Complete source fields
analyses
  1. ci Lower Limit
    -8.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.5
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6701
    param Type
    Difference in percentages
    param Value
    -1.6
    statistical Method
    Miettinen & Nurminen method
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.8
        upper Limit
        19.9
        value
        14.3
      2. group Id
        OG001
        lower Limit
        11.1
        upper Limit
        21.6
        value
        15.8
denoms
  1. counts
    1. group Id
      OG000
      value
      203
    2. group Id
      OG001
      value
      202
    units
    Participants
description
Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.\])
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
NUMBER
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
Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice