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NCT02908672 · OUTCOME

Progression-Free Survival (PFS), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

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 PD or death due to any cause, whichever occurred first (up to approximately 33 months)

What was measured

PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference smallest sum on study, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 millimeters (mm).

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

GroupSource count
Arm A: Pbo + Cobi + Vem258
Arm B: Atezo + Cobi + Vem256

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Pbo + Cobi + Vem10.6Not reported9.312.7Not reported
Arm B: Atezo + Cobi + Vem15.1Not reported11.418.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.97
    estimate Comment
    Stratified Hazard Ratio
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0224
    param Type
    Hazard Ratio (HR)
    param Value
    0.79
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.97
    estimate Comment
    Stratified Hazard Ratio
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0224
    param Type
    Hazard Ratio (HR)
    param Value
    0.79
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.3
        upper Limit
        12.7
        value
        10.6
      2. group Id
        OG001
        lower Limit
        11.4
        upper Limit
        18.4
        value
        15.1
denoms
  1. counts
    1. group Id
      OG000
      value
      258
    2. group Id
      OG001
      value
      256
    units
    Participants
description
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference smallest sum on study, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 millimeters (mm).
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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 PD or death due to any cause, whichever occurred first (up to approximately 33 months)
title
Progression-Free Survival (PFS), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice