NCT02409342 · OUTCOME

Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations

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: NUMBER
Unit: Percentage of participants
Interval / dispersion: Not reported
Time frame: Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 4 Feb 2020 (up to approximately 54.5 months)

What was measured

Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.

Analysis population: Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).

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)	277
Atezolizumab	277

Reported measurements

TC2/3 or IC2/3-WT Population

Analysis denominator · Participants

Group	Source count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	162
Atezolizumab	166

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	32.1	Not reported	Not reported	Not reported	Not reported
Atezolizumab	33.7	Not reported	Not reported	Not reported	Not reported

TC1/2/3 or IC1/2/3-WT Population

Analysis denominator · Participants

Group	Source count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	277
Atezolizumab	277

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)	32.1	Not reported	Not reported	Not reported	Not reported
Atezolizumab	31.4	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
-9.14
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
12.42
group Description
TC2/3 or IC2/3-WT Population
group Ids
OG000
OG001
non Inferiority Comment
Stratified analysis
non Inferiority Type
SUPERIORITY
param Type
Difference in ORR
param Value
1.64
ci Lower Limit
-8.84
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
7.39
group Description
TC1/2/3 or IC1/2/3-WT Population
group Ids
OG000
OG001
non Inferiority Comment
Stratified analysis
non Inferiority Type
SUPERIORITY
param Type
Difference in ORR
param Value
-0.72

Complete source fields

analyses

ci Lower Limit
-9.14
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
12.42
group Description
TC2/3 or IC2/3-WT Population
group Ids
OG000
OG001
non Inferiority Comment
Stratified analysis
non Inferiority Type
SUPERIORITY
param Type
Difference in ORR
param Value
1.64
ci Lower Limit
-8.84
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
7.39
group Description
TC1/2/3 or IC1/2/3-WT Population
group Ids
OG000
OG001
non Inferiority Comment
Stratified analysis
non Inferiority Type
SUPERIORITY
param Type
Difference in ORR
param Value
-0.72

classes

categories
measurements
group Id
OG000
value
32.1
group Id
OG001
value
33.7
denoms
counts
group Id
OG000
value
162
group Id
OG001
value
166
units
Participants
title
TC2/3 or IC2/3-WT Population
categories
measurements
group Id
OG000
value
32.1
group Id
OG001
value
31.4
denoms
counts
group Id
OG000
value
277
group Id
OG001
value
277
units
Participants
title
TC1/2/3 or IC1/2/3-WT Population

denoms

counts
group Id
OG000
value
277
group Id
OG001
value
277
units
Participants

description

Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.

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

NUMBER

population Description

Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type \[WT\]).

reporting Status

POSTED

time Frame

Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 4 Feb 2020 (up to approximately 54.5 months)

title

Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations

type

SECONDARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice