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NCT03106779 · OUTCOME

Major Molecular Response (MMR) Rate at 24 Weeks

Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs · Source last updated 2026-08-18

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
Not reported
Time frame
24 weeks

What was measured

MMR was defined as a ≥ 3.0 log reduction in BCR-ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1% BCR-ABL1/ABL% by international scale (IS) as measured by RQ-PCR.

Analysis population: Full Analysis Set (FAS): The FAS comprised of all randomized participants.

Groups in this outcome

Asciminib

Participants randomized to asciminib 40mg BID

Bosutinib

Participants randomized to bosutinib 500mg QD

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

Analysis denominator · Participants

GroupSource count
Asciminib157
Bosutinib76

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib25.48Not reportedNot reportedNot reportedNot reported
Bosutinib13.16Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    2.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    22.30
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.029
    param Type
    treatment difference in the MMR rate
    param Value
    12.2
    statistical Comment
    Stratified by the randomization stratification factor, i.e. cytogenetic response status (MCyR vs no MCyR) at screening
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    2.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    22.30
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.029
    param Type
    treatment difference in the MMR rate
    param Value
    12.2
    statistical Comment
    Stratified by the randomization stratification factor, i.e. cytogenetic response status (MCyR vs no MCyR) at screening
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25.48
      2. group Id
        OG001
        value
        13.16
denoms
  1. counts
    1. group Id
      OG000
      value
      157
    2. group Id
      OG001
      value
      76
    units
    Participants
description
MMR was defined as a ≥ 3.0 log reduction in BCR-ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1% BCR-ABL1/ABL% by international scale (IS) as measured by RQ-PCR.
groups
  1. description
    Participants randomized to asciminib 40mg BID
    id
    OG000
    title
    Asciminib
  2. description
    Participants randomized to bosutinib 500mg QD
    id
    OG001
    title
    Bosutinib
param Type
NUMBER
population Description
Full Analysis Set (FAS): The FAS comprised of all randomized participants.
reporting Status
POSTED
time Frame
24 weeks
title
Major Molecular Response (MMR) Rate at 24 Weeks
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice