NCT02302807 · OUTCOME

Percentage of Participants With Unconfirmed Objective Response Rate (ORR) as Determined by the Investigator With Use of Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] · Source last updated 2019-08-01

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: Up to approximately 25 months after first participant enrolled

What was measured

ORR was defined as the percentage of participants, who had an objective response. Objective response was defined as either a complete response (CR) or partial response (PR) as determined by the investigator with use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). Objective response in this study did not need to be a confirmed response. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. ORR=CR+PR

Analysis population: ORR analyses was performed on all randomized patients who had measureable disease at baseline

Groups in this outcome

Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)

Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.

Atezolizumab

Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

IC2/3 Chemotherapy

PD-L1 immunohistochemistry (IHC) score of IC2/3

IC2/3 Atezolizumab

PD-L1 immunohistochemistry (IHC) score of IC2/3

IC1/2/3 Chemotherapy

PD-L1 immunohistochemistry (IHC) score of IC1/2/3

IC1/2/3 Atezolizumab

PD-L1 immunohistochemistry (IHC) score of IC1/2/3

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 (Vinflunine, Paclitaxel, or Docetaxel)	461
Atezolizumab	462
IC2/3 Chemotherapy	116
IC2/3 Atezolizumab	113
IC1/2/3 Chemotherapy	306
IC1/2/3 Atezolizumab	312

Reported measurements

Source class 1

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)	20.8	Not reported	17.21	24.82	Not reported
Atezolizumab	15.4	Not reported	12.20	18.99	Not reported
IC2/3 Chemotherapy	29.3	Not reported	21.23	38.48	Not reported
IC2/3 Atezolizumab	26.5	Not reported	18.68	35.68	Not reported
IC1/2/3 Chemotherapy	22.2	Not reported	17.69	27.30	Not reported
IC1/2/3 Atezolizumab	16.3	Not reported	12.42	20.93	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
17.21
upper Limit
24.82
value
20.8
group Id
OG001
lower Limit
12.20
upper Limit
18.99
value
15.4
group Id
OG002
lower Limit
21.23
upper Limit
38.48
value
29.3
group Id
OG003
lower Limit
18.68
upper Limit
35.68
value
26.5
group Id
OG004
lower Limit
17.69
upper Limit
27.30
value
22.2
group Id
OG005
lower Limit
12.42
upper Limit
20.93
value
16.3

denoms

counts
group Id
OG000
value
461
group Id
OG001
value
462
group Id
OG002
value
116
group Id
OG003
value
113
group Id
OG004
value
306
group Id
OG005
value
312
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
id
OG000
title
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
description
Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
id
OG001
title
Atezolizumab
description
PD-L1 immunohistochemistry (IHC) score of IC2/3
id
OG002
title
IC2/3 Chemotherapy
description
PD-L1 immunohistochemistry (IHC) score of IC2/3
id
OG003
title
IC2/3 Atezolizumab
description
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
id
OG004
title
IC1/2/3 Chemotherapy
description
PD-L1 immunohistochemistry (IHC) score of IC1/2/3
id
OG005
title
IC1/2/3 Atezolizumab

param Type

NUMBER

population Description

ORR analyses was performed on all randomized patients who had measureable disease at baseline

reporting Status

POSTED

time Frame

Up to approximately 25 months after first participant enrolled

title

Percentage of Participants With Unconfirmed Objective Response Rate (ORR) as Determined by the Investigator With Use of Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)

type

SECONDARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice