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NCT03312530 · OUTCOME

Percentage of Participants With Clinical Benefit as Determined by the Investigator Using IMWG Response Criteria

A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma · Source last updated 2023-02-28

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
From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 3 years, 7 months)

What was measured

Clinical benefit rate (CBR) was defined as a minimal response (MR) or better (PR,VGPR, CR, sCR).

Analysis population: The safety evaluable population included all participants who received any amount of study drug.

Groups in this outcome

Safety Run-In: Cobimetinib + Venetoclax

Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.

Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab

Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.

A: Cobimetinib

Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.

B: Cobimetinib + Venetoclax

Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.

C: Cobimetinib + Venetoclax + Atezolizumab

Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, 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
Safety Run-In: Cobimetinib + Venetoclax6
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab6
A: Cobimetinib6
B: Cobimetinib + Venetoclax16
C: Cobimetinib + Venetoclax + Atezolizumab15

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Safety Run-In: Cobimetinib + Venetoclax33.3Not reported0.0079.39Not reported
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab33.3Not reported0.0079.39Not reported
A: Cobimetinib0Not reported0.008.33Not reported
B: Cobimetinib + Venetoclax43.8Not reported16.3271.18Not reported
C: Cobimetinib + Venetoclax + Atezolizumab33.3Not reported6.1460.52Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        79.39
        value
        33.3
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        79.39
        value
        33.3
      3. group Id
        OG002
        lower Limit
        0.00
        upper Limit
        8.33
        value
        0
      4. group Id
        OG003
        lower Limit
        16.32
        upper Limit
        71.18
        value
        43.8
      5. group Id
        OG004
        lower Limit
        6.14
        upper Limit
        60.52
        value
        33.3
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      16
    5. group Id
      OG004
      value
      15
    units
    Participants
description
Clinical benefit rate (CBR) was defined as a minimal response (MR) or better (PR,VGPR, CR, sCR).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
    id
    OG000
    title
    Safety Run-In: Cobimetinib + Venetoclax
  2. description
    Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
    id
    OG001
    title
    Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
  3. description
    Participants received the standard single-agent cobimetinib dose of 60 milligrams (mg) (3 tablets of 20 mg each) orally (PO) daily on Days 1-21 of each 28-day cycle until disease progression. Upon progression, participants were allowed to receive treatment with cobimetinib and atezolizumab at the recommended Phase II dose of cobimetinib 60 mg PO on Days 1-21 plus atezolizumab intravenous (IV) infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
    id
    OG002
    title
    A: Cobimetinib
  4. description
    Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
    id
    OG003
    title
    B: Cobimetinib + Venetoclax
  5. description
    Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
    id
    OG004
    title
    C: Cobimetinib + Venetoclax + Atezolizumab
param Type
NUMBER
population Description
The safety evaluable population included all participants who received any amount of study drug.
reporting Status
POSTED
time Frame
From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 3 years, 7 months)
title
Percentage of Participants With Clinical Benefit as Determined by the Investigator Using IMWG Response Criteria
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice