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NCT04266301 · OUTCOME

Key Secondary Endpoint 3: Percentage of Participants With at Least 3 Point Confirmed Improvement From Baseline in FACIT-fatigue Scores

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) · Source last updated 2026-01-13

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

Measure
NUMBER
Unit
Percentage of participants with response
Interval / dispersion
95% Confidence Interval
Time frame
up to approx. 52 months

What was measured

FACIT-Fatigue score is a 13-item questionnaire designed to assess fatigue in cancer participants. All items use a 5-point scale ranging from 0 to 4 (0=Not at All to 4=Very Much). The total score ranges from 0 to 52 with higher values representing better quality of life. The responder is defined as having 3 points improvement from baseline confirmed by a second improvement of 3 points at any time, regardless of preceding worsening. A participant who could not improve was considered as a non-responder.

Analysis population: FAS comprised of all participants to whom study treatment had been assigned by randomization.

Groups in this outcome

Sabatolimab (MBG453) + Azacitidine

Participants were randomized to sabatolimab plus Azacitidine

Placebo + Azacitidine

Participants were randomized to placebo plus Azacitidine

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

Analysis denominator · Participants

GroupSource count
Sabatolimab (MBG453) + Azacitidine265
Placebo + Azacitidine265

Reported measurements

Source class 1
Values in Percentage of participants with response · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453) + Azacitidine39.6Not reported33.745.8Not reported
Placebo + Azacitidine40.8Not reported34.846.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4865
    p Value Comment
    P Value is 1-sided
    param Type
    Odds Ratio (OR)
    param Value
    0.95
    statistical Comment
    exact CMH Chi-square statistic, adjusting for randomization stratification factor as per IRT.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4865
    p Value Comment
    P Value is 1-sided
    param Type
    Odds Ratio (OR)
    param Value
    0.95
    statistical Comment
    exact CMH Chi-square statistic, adjusting for randomization stratification factor as per IRT.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.7
        upper Limit
        45.8
        value
        39.6
      2. group Id
        OG001
        lower Limit
        34.8
        upper Limit
        46.9
        value
        40.8
denoms
  1. counts
    1. group Id
      OG000
      value
      265
    2. group Id
      OG001
      value
      265
    units
    Participants
description
FACIT-Fatigue score is a 13-item questionnaire designed to assess fatigue in cancer participants. All items use a 5-point scale ranging from 0 to 4 (0=Not at All to 4=Very Much). The total score ranges from 0 to 52 with higher values representing better quality of life. The responder is defined as having 3 points improvement from baseline confirmed by a second improvement of 3 points at any time, regardless of preceding worsening. A participant who could not improve was considered as a non-responder.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were randomized to sabatolimab plus Azacitidine
    id
    OG000
    title
    Sabatolimab (MBG453) + Azacitidine
  2. description
    Participants were randomized to placebo plus Azacitidine
    id
    OG001
    title
    Placebo + Azacitidine
param Type
NUMBER
population Description
FAS comprised of all participants to whom study treatment had been assigned by randomization.
reporting Status
POSTED
time Frame
up to approx. 52 months
title
Key Secondary Endpoint 3: Percentage of Participants With at Least 3 Point Confirmed Improvement From Baseline in FACIT-fatigue Scores
type
SECONDARY
unit Of Measure
Percentage of participants with response

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Preserved source evidence · Not medical advice