NCT01905657 · OUTCOME

Overall Response Rate (ORR) by 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: NUMBER
Unit: Percentage of Participants
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

ORR was defined as the percentage of participants in the analysis population 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, taking as reference the baseline sum of diameters) based on blinded independent central radiologists' review using RECIST 1.1. Per protocol, final analysis for this secondary 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, ORR 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 ORR 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 Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Pembrolizumab 2 mg/kg	30.2	Not reported	22.7	38.6	Not reported
Pembrolizumab 10 mg/kg	29.1	Not reported	22.0	37.1	Not reported
Docetaxel 75 mg/m^2	7.9	Not reported	4.1	13.4	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 Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Pembrolizumab 2 mg/kg	18.0	Not reported	14.1	22.5	Not reported
Pembrolizumab 10 mg/kg	18.5	Not reported	14.5	23.0	Not reported
Docetaxel 75 mg/m^2	9.3	Not reported	6.5	12.9	Not reported

Source statistical analyses

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

ci Lower Limit
-12.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
8.2
estimate Comment
This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.
group Description
In participants with strongly PD-L1 positive tumors
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.66608
p Value Comment
P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage not equal to 0, in accordance with the statistical analysis plan.
param Type
Difference in Percentages
param Value
-2.3
statistical Method
Miettinen & Nurminen method
ci Lower Limit
14.0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
30.7
estimate Comment
This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.
group Description
In participants with strongly PD-L1 positive tumors
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
<0.00001
p Value Comment
P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.
param Type
Difference in Percentages
param Value
22.2
statistical Method
Miettinen & Nurminen method
ci Lower Limit
3.6
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
13.9
estimate Comment
This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.
group Description
In participants with PD-L1 positive tumors
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00045
p Value Comment
P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.
param Type
Difference in Percentages
param Value
8.7
statistical Method
Miettinen & Nurminen method
ci Lower Limit
4.1
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
14.3
estimate Comment
This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.
group Description
In participants with PD-L1 positive tumors
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00024
p Value Comment
P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.
param Type
Difference in Percentages
param Value
9.1
statistical Method
Miettinen & Nurminen method

Complete source fields

analyses

ci Lower Limit
-12.7
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
8.2
estimate Comment
This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.
group Description
In participants with strongly PD-L1 positive tumors
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.66608
p Value Comment
P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage not equal to 0, in accordance with the statistical analysis plan.
param Type
Difference in Percentages
param Value
-2.3
statistical Method
Miettinen & Nurminen method
ci Lower Limit
14.0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
30.7
estimate Comment
This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.
group Description
In participants with strongly PD-L1 positive tumors
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
<0.00001
p Value Comment
P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.
param Type
Difference in Percentages
param Value
22.2
statistical Method
Miettinen & Nurminen method
ci Lower Limit
3.6
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
13.9
estimate Comment
This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.
group Description
In participants with PD-L1 positive tumors
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00045
p Value Comment
P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.
param Type
Difference in Percentages
param Value
8.7
statistical Method
Miettinen & Nurminen method
ci Lower Limit
4.1
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
14.3
estimate Comment
This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.
group Description
In participants with PD-L1 positive tumors
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER_LEGACY
p Value
0.00024
p Value Comment
P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.
param Type
Difference in Percentages
param Value
9.1
statistical Method
Miettinen & Nurminen method

classes

categories
measurements
group Id
OG000
lower Limit
22.7
upper Limit
38.6
value
30.2
group Id
OG001
lower Limit
22.0
upper Limit
37.1
value
29.1
group Id
OG002
lower Limit
4.1
upper Limit
13.4
value
7.9
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
14.1
upper Limit
22.5
value
18.0
group Id
OG001
lower Limit
14.5
upper Limit
23.0
value
18.5
group Id
OG002
lower Limit
6.5
upper Limit
12.9
value
9.3
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

NUMBER

population Description

Per protocol, ORR 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 ORR 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

Overall Response Rate (ORR) by RECIST 1.1

type

SECONDARY

unit Of Measure

Percentage of Participants

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