NCT02555657 · OUTCOME

Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10

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 ≥10 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

Group	Source count
Pembrolizumab	96
Chemotherapy	98

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Pembrolizumab	12.7	Not reported	9.9	16.3	Not reported
Chemotherapy	11.6	Not reported	8.3	13.7	Not reported

Source statistical analyses

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

ci Lower Limit
0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.06
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0574
param Type
Hazard Ratio (HR)
param Value
0.78
statistical Method
Regression, Cox

Complete source fields

analyses

ci Lower Limit
0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.06
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0574
param Type
Hazard Ratio (HR)
param Value
0.78
statistical Method
Regression, Cox

classes

categories
measurements
group Id
OG000
lower Limit
9.9
upper Limit
16.3
value
12.7
group Id
OG001
lower Limit
8.3
upper Limit
13.7
value
11.6

denoms

counts
group Id
OG000
value
96
group Id
OG001
value
98
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

description
Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to \~2 years).
id
OG000
title
Pembrolizumab
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 ≥10 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 Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10

type

PRIMARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice