NCT02928224 · OUTCOME

(Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis

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 89.1 weeks for triplet arm and 52.4 weeks for control arm)

What was measured

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

Analysis population: The Full Analysis Set (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: Control Arm

Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.

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
Phase 3: Triplet Arm	224
Phase 3: Control Arm	221

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	9.03	Not reported	8.02	11.43	Not reported
Phase 3: Control Arm	5.42	Not reported	4.76	6.57	Not reported

Source statistical analyses

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

group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
<0.0001
statistical Method
Stratified Log-rank

Complete source fields

analyses

group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
<0.0001
statistical Method
Stratified Log-rank

classes

categories
measurements
group Id
OG000
lower Limit
8.02
upper Limit
11.43
value
9.03
group Id
OG001
lower Limit
4.76
upper Limit
6.57
value
5.42

denoms

counts
group Id
OG000
value
224
group Id
OG001
value
221
units
Participants

description

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

dispersion Type

95% Confidence Interval

groups

description
Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
id
OG000
title
Phase 3: Triplet Arm
description
Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.
id
OG001
title
Phase 3: Control Arm

param Type

MEDIAN

population Description

The Full Analysis Set (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 89.1 weeks for triplet arm and 52.4 weeks for control arm)

title

(Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis

type

PRIMARY

unit Of Measure

Months

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

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