NCT02409342 · OUTCOME

OS in Participants With Blood Tumor Mutational Burden (bTMB)

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110] · Source last updated 2023-03-15

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: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)

What was measured

OS is defined as the time from randomization to death from any cause.

Analysis population: Analysis was performed for the bTMB subpopulations in the Intent-to-Treat Wild Type population.

Groups in this outcome

Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).

Atezolizumab

Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).

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
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	83
Atezolizumab	92

Reported measurements

bTMB >=10-WT Population

Analysis denominator · Participants

Group	Source count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	83
Atezolizumab	92

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	10.3	Not reported	7.1	16.9	Not reported
Atezolizumab	11.2	Not reported	7.9	NA	Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.

bTMB >=16-WT Population

Analysis denominator · Participants

Group	Source count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	45
Atezolizumab	42

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	8.5	Not reported	5.8	NA	Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
Atezolizumab	13.9	Not reported	10.8	NA	Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.

bTMB >=20-WT Population

Analysis denominator · Participants

Group	Source count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	29
Atezolizumab	27

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	10.5	Not reported	5.8	NA	Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
Atezolizumab	17.2	Not reported	10.8	NA	Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.

Source statistical analyses

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

ci Lower Limit
0.578
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.301
group Description
bTMB \>=10-WT Population
group Ids
OG000
OG001
non Inferiority Comment
Unstratified analysis
non Inferiority Type
SUPERIORITY
param Type
Hazard Ratio (HR)
param Value
0.867
ci Lower Limit
0.414
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.351
group Description
bTMB \>=16-WT Population
group Ids
OG000
OG001
non Inferiority Comment
Unstratified analysis
non Inferiority Type
SUPERIORITY
param Type
Hazard Ratio (HR)
param Value
0.748
ci Lower Limit
0.362
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.638
group Description
bTMB \>=20-WT Population
group Ids
OG000
OG001
non Inferiority Comment
Unstratified analysis
non Inferiority Type
SUPERIORITY
param Type
Hazard Ratio (HR)
param Value
0.770

Complete source fields

analyses

ci Lower Limit
0.578
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.301
group Description
bTMB \>=10-WT Population
group Ids
OG000
OG001
non Inferiority Comment
Unstratified analysis
non Inferiority Type
SUPERIORITY
param Type
Hazard Ratio (HR)
param Value
0.867
ci Lower Limit
0.414
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.351
group Description
bTMB \>=16-WT Population
group Ids
OG000
OG001
non Inferiority Comment
Unstratified analysis
non Inferiority Type
SUPERIORITY
param Type
Hazard Ratio (HR)
param Value
0.748
ci Lower Limit
0.362
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.638
group Description
bTMB \>=20-WT Population
group Ids
OG000
OG001
non Inferiority Comment
Unstratified analysis
non Inferiority Type
SUPERIORITY
param Type
Hazard Ratio (HR)
param Value
0.770

classes

categories
measurements
group Id
OG000
lower Limit
7.1
upper Limit
16.9
value
10.3
comment
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
group Id
OG001
lower Limit
7.9
upper Limit
NA
value
11.2
denoms
counts
group Id
OG000
value
83
group Id
OG001
value
92
units
Participants
title
bTMB >=10-WT Population
categories
measurements
comment
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
group Id
OG000
lower Limit
5.8
upper Limit
NA
value
8.5
comment
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
group Id
OG001
lower Limit
10.8
upper Limit
NA
value
13.9
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
42
units
Participants
title
bTMB >=16-WT Population
categories
measurements
comment
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
group Id
OG000
lower Limit
5.8
upper Limit
NA
value
10.5
comment
Upper limit of 95% confidence interval is not estimable by Brookmeyer and Crowley method due to insufficient number of observed events.
group Id
OG001
lower Limit
10.8
upper Limit
NA
value
17.2
denoms
counts
group Id
OG000
value
29
group Id
OG001
value
27
units
Participants
title
bTMB >=20-WT Population

denoms

counts
group Id
OG000
value
83
group Id
OG001
value
92
units
Participants

description

OS is defined as the time from randomization to death from any cause.

dispersion Type

95% Confidence Interval

groups

description
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
id
OG000
title
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
description
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
id
OG001
title
Atezolizumab

param Type

MEDIAN

population Description

Analysis was performed for the bTMB subpopulations in the Intent-to-Treat Wild Type population.

reporting Status

POSTED

time Frame

From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)

title

OS in Participants With Blood Tumor Mutational Burden (bTMB)

type

SECONDARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice