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NCT04266301 · OUTCOME

Overall Survival (OS) (Primary Efficacy Results)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
up to approx. 39 months

What was measured

OS is the time from randomization until death due to any cause.

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sabatolimab (MBG453) + Azacitidine22.31Not reported19.5524.74Not reported
Placebo + Azacitidine18.83Not reported15.3823.72Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.671
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.070
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0825
    p Value Comment
    P Value is 1-sided
    param Type
    Hazard Ratio (HR)
    param Value
    0.847
    statistical Comment
    Log-rank test stratified by randomization stratification factor (Intermediate risk MDS, High risk MDS, Very high risk MDS, CMML-2) as per IRT
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.671
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.070
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0825
    p Value Comment
    P Value is 1-sided
    param Type
    Hazard Ratio (HR)
    param Value
    0.847
    statistical Comment
    Log-rank test stratified by randomization stratification factor (Intermediate risk MDS, High risk MDS, Very high risk MDS, CMML-2) as per IRT
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.55
        upper Limit
        24.74
        value
        22.31
      2. group Id
        OG001
        lower Limit
        15.38
        upper Limit
        23.72
        value
        18.83
denoms
  1. counts
    1. group Id
      OG000
      value
      265
    2. group Id
      OG001
      value
      265
    units
    Participants
description
OS is the time from randomization until death due to any cause.
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
MEDIAN
population Description
FAS comprised of all participants to whom study treatment had been assigned by randomization.
reporting Status
POSTED
time Frame
up to approx. 39 months
title
Overall Survival (OS) (Primary Efficacy Results)
type
PRIMARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice