NCT02908672 · OUTCOME

Overall Survival (OS)

A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma · Source last updated 2025-07-20

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: Baseline up to death due to any cause (up to approximately 85 months)

What was measured

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

Analysis population: ITT population included all randomized participants, whether or not study treatment was received.

Groups in this outcome

Arm A: Pbo + Cobi + Vem

Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.

Arm B: Atezo + Cobi + Vem

Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.

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
Arm A: Pbo + Cobi + Vem	258
Arm B: Atezo + Cobi + Vem	256

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Pbo + Cobi + Vem	25.8	Not reported	22.0	34.6	Not reported
Arm B: Atezo + Cobi + Vem	39.0	Not reported	29.9	55.3	Not reported

Source statistical analyses

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

ci Lower Limit
0.67
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.05
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.1191
param Type
Hazard Ratio (HR)
param Value
0.84
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.67
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.05
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.1191
param Type
Hazard Ratio (HR)
param Value
0.84
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
22.0
upper Limit
34.6
value
25.8
group Id
OG001
lower Limit
29.9
upper Limit
55.3
value
39.0

denoms

counts
group Id
OG000
value
258
group Id
OG001
value
256
units
Participants

description

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

dispersion Type

95% Confidence Interval

groups

description
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
id
OG000
title
Arm A: Pbo + Cobi + Vem
description
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
id
OG001
title
Arm B: Atezo + Cobi + Vem

param Type

MEDIAN

population Description

ITT population included all randomized participants, whether or not study treatment was received.

reporting Status

POSTED

time Frame

Baseline up to death due to any cause (up to approximately 85 months)

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice