NCT01905657 · OUTCOME

Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010) · Source last updated 2021-10-06

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: Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)

What was measured

PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \>5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.

Analysis population: Per protocol, PFS for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive PFS data available and usable. Participants were included in the treatment group to which they were randomized.

Groups in this outcome

Pembrolizumab 2 mg/kg

Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.

Pembrolizumab 10 mg/kg

Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.

Docetaxel 75 mg/m^2

Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.

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 2 mg/kg	344
Pembrolizumab 10 mg/kg	346
Docetaxel 75 mg/m^2	343

Reported measurements

Strongly PD-L1 Positive

Analysis denominator · Participants

Group	Source count
Pembrolizumab 2 mg/kg	139
Pembrolizumab 10 mg/kg	151
Docetaxel 75 mg/m^2	152

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Pembrolizumab 2 mg/kg	5.2	Not reported	4.0	6.5	Not reported
Pembrolizumab 10 mg/kg	5.2	Not reported	4.1	8.1	Not reported
Docetaxel 75 mg/m^2	4.1	Not reported	3.6	4.3	Not reported

All PD-L1 Positive

Analysis denominator · Participants

Group	Source count
Pembrolizumab 2 mg/kg	344
Pembrolizumab 10 mg/kg	346
Docetaxel 75 mg/m^2	343

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Pembrolizumab 2 mg/kg	3.9	Not reported	3.1	4.1	Not reported
Pembrolizumab 10 mg/kg	4.0	Not reported	2.6	4.3	Not reported
Docetaxel 75 mg/m^2	4.0	Not reported	3.1	4.2	Not reported

Source statistical analyses

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

ci Lower Limit
0.43
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.77
estimate Comment
Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2
group Description
In participants with strongly PD-L1 positive tumors
group Ids
OG000
OG002
non Inferiority Comment
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00009
param Type
Hazard Ratio (HR)
param Value
0.58
statistical Method
Log Rank
ci Lower Limit
0.45
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.78
estimate Comment
Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2
group Description
In participants with strongly PD-L1 positive tumors
group Ids
OG001
OG002
non Inferiority Comment
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00007
param Type
Hazard Ratio (HR)
param Value
0.59
statistical Method
Log Rank
ci Lower Limit
0.73
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.04
estimate Comment
Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2
group Description
In participants with PD-L1 positive tumors
group Ids
OG000
OG002
non Inferiority Comment
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.06758
param Type
Hazard Ratio (HR)
param Value
0.88
statistical Method
Log Rank
ci Lower Limit
0.66
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.94
estimate Comment
Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2
group Description
In participants with PD-L1 positive tumors
group Ids
OG001
OG002
non Inferiority Comment
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00462
param Type
Hazard Ratio (HR)
param Value
0.79
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.43
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.77
estimate Comment
Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2
group Description
In participants with strongly PD-L1 positive tumors
group Ids
OG000
OG002
non Inferiority Comment
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00009
param Type
Hazard Ratio (HR)
param Value
0.58
statistical Method
Log Rank
ci Lower Limit
0.45
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.78
estimate Comment
Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2
group Description
In participants with strongly PD-L1 positive tumors
group Ids
OG001
OG002
non Inferiority Comment
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00007
param Type
Hazard Ratio (HR)
param Value
0.59
statistical Method
Log Rank
ci Lower Limit
0.73
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.04
estimate Comment
Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2
group Description
In participants with PD-L1 positive tumors
group Ids
OG000
OG002
non Inferiority Comment
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.06758
param Type
Hazard Ratio (HR)
param Value
0.88
statistical Method
Log Rank
ci Lower Limit
0.66
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.94
estimate Comment
Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2
group Description
In participants with PD-L1 positive tumors
group Ids
OG001
OG002
non Inferiority Comment
Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00462
param Type
Hazard Ratio (HR)
param Value
0.79
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
4.0
upper Limit
6.5
value
5.2
group Id
OG001
lower Limit
4.1
upper Limit
8.1
value
5.2
group Id
OG002
lower Limit
3.6
upper Limit
4.3
value
4.1
denoms
counts
group Id
OG000
value
139
group Id
OG001
value
151
group Id
OG002
value
152
units
Participants
title
Strongly PD-L1 Positive
categories
measurements
group Id
OG000
lower Limit
3.1
upper Limit
4.1
value
3.9
group Id
OG001
lower Limit
2.6
upper Limit
4.3
value
4.0
group Id
OG002
lower Limit
3.1
upper Limit
4.2
value
4.0
denoms
counts
group Id
OG000
value
344
group Id
OG001
value
346
group Id
OG002
value
343
units
Participants
title
All PD-L1 Positive

denoms

counts
group Id
OG000
value
344
group Id
OG001
value
346
group Id
OG002
value
343
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
id
OG000
title
Pembrolizumab 2 mg/kg
description
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
id
OG001
title
Pembrolizumab 10 mg/kg
description
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
id
OG002
title
Docetaxel 75 mg/m^2

param Type

MEDIAN

population Description

Per protocol, PFS for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive PFS data available and usable. Participants were included in the treatment group to which they were randomized.

reporting Status

POSTED

time Frame

Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)

title

Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

type

PRIMARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice