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NCT02928224 · OUTCOME

(Phase 3) Overall Survival (OS) in Triplet Arm vs. Doublet Arm

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer · Source last updated 2023-12-21

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
From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.7 weeks for doublet arm and 89.1 weeks for triplet arm)

What was measured

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

Analysis population: The FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants.

Groups in this outcome

Phase 3: Triplet Arm

Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.

Phase 3: Doublet Arm

Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 3: Triplet Arm224
Phase 3: Doublet Arm220

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 3: Triplet Arm9.82Not reported8.3411.73Not reported
Phase 3: Doublet Arm9.40Not reported8.1111.24Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.5958
    statistical Method
    Stratified Log-rank
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.5958
    statistical Method
    Stratified Log-rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.34
        upper Limit
        11.73
        value
        9.82
      2. group Id
        OG001
        lower Limit
        8.11
        upper Limit
        11.24
        value
        9.40
denoms
  1. counts
    1. group Id
      OG000
      value
      224
    2. group Id
      OG001
      value
      220
    units
    Participants
description
OS was defined as the time from randomization to death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
    id
    OG000
    title
    Phase 3: Triplet Arm
  2. description
    Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.
    id
    OG001
    title
    Phase 3: Doublet Arm
param Type
MEDIAN
population Description
The FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants.
reporting Status
POSTED
time Frame
From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.7 weeks for doublet arm and 89.1 weeks for triplet arm)
title
(Phase 3) Overall Survival (OS) in Triplet Arm vs. Doublet Arm
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice