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NCT04971226 · OUTCOME

Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum)

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP · Source last updated 2026-08-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At 48 weeks

What was measured

Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL1/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).

Analysis population: The IMA Full Analysis Set (FASIMA) comprised of all participants from the FAS, whose PRS TKI is imatinib. FAS comprised of all participants to whom study treatment has been assigned by randomization.

Groups in this outcome

Asciminib (Imatinib Stratum)

Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.

Investigator Selected TKI (Imatinib Stratum)

Patients took on ongoing basis the Investigator selected TKI (imatinib)

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

Analysis denominator · Participants

GroupSource count
Asciminib (Imatinib Stratum)101
Investigator Selected TKI (Imatinib Stratum)102

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Asciminib (Imatinib Stratum)70Not reportedNot reportedNot reportedNot reported
Investigator Selected TKI (Imatinib Stratum)41Not 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
    16.91
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    42.18
    estimate Comment
    The Estimate Value is a percentage.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    The Confidence Interval are percentages.
    p Value
    <0.001
    param Type
    Risk Difference (RD)
    param Value
    29.55
    statistical Method
    Mantel Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    16.91
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    42.18
    estimate Comment
    The Estimate Value is a percentage.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    The Confidence Interval are percentages.
    p Value
    <0.001
    param Type
    Risk Difference (RD)
    param Value
    29.55
    statistical Method
    Mantel Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        70
      2. group Id
        OG001
        value
        41
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    2. group Id
      OG001
      value
      102
    units
    Participants
description
Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL1/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
groups
  1. description
    Patients took asciminib 80 mg QD under fasting conditions on ongoing basis.
    id
    OG000
    title
    Asciminib (Imatinib Stratum)
  2. description
    Patients took on ongoing basis the Investigator selected TKI (imatinib)
    id
    OG001
    title
    Investigator Selected TKI (Imatinib Stratum)
param Type
COUNT_OF_PARTICIPANTS
population Description
The IMA Full Analysis Set (FASIMA) comprised of all participants from the FAS, whose PRS TKI is imatinib. FAS comprised of all participants to whom study treatment has been assigned by randomization.
reporting Status
POSTED
time Frame
At 48 weeks
title
Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Asciminib (Imatinib Stratum) vs Investigator Selected TKI (Imatinib Stratum)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice