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NCT04607421 · OUTCOME

Phase 3: DOR by Derived Investigator Assessment for Arm B Versus Arm C - FAS ORR Subset

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer · Source last updated 2026-06-11

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 date of first radiographic evidence of response (CR or PR) to earliest documented PD or death due to any cause, whichever occurred first (maximum up to 24.71 months)

What was measured

DOR was defined as the time from the date of first radiographic evidence of response (CR or PR) to the earliest documented PD per RECIST v1.1 by derived investigator assessment, or death due to any cause. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion. Analysis was performed using Kaplan Meier method.

Analysis population: The FAS for Phase 3, ORR subset included the first 110 participants randomized in each Arm B and Arm C. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with a confirmed objective response by derived investigator assessment. As pre-specified in protocol of the study, this outcome measure was planned to compare DOR by derived investigator assessment between Arm B and Arm C of Phase 3. Hence, Arm A is not reported in this outcome measure.

Groups in this outcome

Phase 3: Arm B [EC + mFOLFOX6]

Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.

Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]

Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.

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: Arm B [EC + mFOLFOX6]71
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]44

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 3: Arm B [EC + mFOLFOX6]12.5Not reported9.4NAThe upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]8.3Not reported5.511.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        9.4
        upper Limit
        NA
        value
        12.5
      2. group Id
        OG001
        lower Limit
        5.5
        upper Limit
        11.3
        value
        8.3
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    2. group Id
      OG001
      value
      44
    units
    Participants
description
DOR was defined as the time from the date of first radiographic evidence of response (CR or PR) to the earliest documented PD per RECIST v1.1 by derived investigator assessment, or death due to any cause. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion. Analysis was performed using Kaplan Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
    id
    OG000
    title
    Phase 3: Arm B [EC + mFOLFOX6]
  2. description
    Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.
    id
    OG001
    title
    Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]
param Type
MEDIAN
population Description
The FAS for Phase 3, ORR subset included the first 110 participants randomized in each Arm B and Arm C. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with a confirmed objective response by derived investigator assessment. As pre-specified in protocol of the study, this outcome measure was planned to compare DOR by derived investigator assessment between Arm B and Arm C of Phase 3. Hence, Arm A is not reported in this outcome measure.
reporting Status
POSTED
time Frame
From date of first radiographic evidence of response (CR or PR) to earliest documented PD or death due to any cause, whichever occurred first (maximum up to 24.71 months)
title
Phase 3: DOR by Derived Investigator Assessment for Arm B Versus Arm C - FAS ORR Subset
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice