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NCT04266301 · OUTCOME

Progression Free Survival (PFS)

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. 52 months

What was measured

PFS is defined as the time from randomization to disease progression (including transformation to acute leukemia per WHO 2016), relapse from CR (IWG-MDS), or death. Disease progression: bone marrow blasts increase ≥ 50% over baseline, to \> 5% if initially \< 5%, \> 10% if 5%-\<10%, or \> 20% if 10%-\<20%. Includes a peripheral blood count decrease ≥ 50% from maximum remission/response levels: neutrophils \< 1.0x109/L, platelets \< 100x109/L, or hemoglobin drop ≥ 2 g/dL to \< 10 g/dL, becoming transfusion-dependent. Relapse from CR: baseline bone marrow blast % return, neutrophils decrease ≥ 50% to \< 1.0x109/L, platelets decrease ≥ 50% to \< 100x109/L, or hemoglobin drop ≥ 1.5 g/dL to \< 10 g/dL, becoming transfusion-dependent. Leukemia transformation: \> 20% blasts per WHO 2016 (Arber et al 2016).

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) + Azacitidine14.26Not reported12.2217.74Not reported
Placebo + Azacitidine10.12Not reported8.6411.14Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.576
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.875
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.710
Complete source fields
analyses
  1. ci Lower Limit
    0.576
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.875
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.710
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.22
        upper Limit
        17.74
        value
        14.26
      2. group Id
        OG001
        lower Limit
        8.64
        upper Limit
        11.14
        value
        10.12
denoms
  1. counts
    1. group Id
      OG000
      value
      265
    2. group Id
      OG001
      value
      265
    units
    Participants
description
PFS is defined as the time from randomization to disease progression (including transformation to acute leukemia per WHO 2016), relapse from CR (IWG-MDS), or death. Disease progression: bone marrow blasts increase ≥ 50% over baseline, to \> 5% if initially \< 5%, \> 10% if 5%-\<10%, or \> 20% if 10%-\<20%. Includes a peripheral blood count decrease ≥ 50% from maximum remission/response levels: neutrophils \< 1.0x109/L, platelets \< 100x109/L, or hemoglobin drop ≥ 2 g/dL to \< 10 g/dL, becoming transfusion-dependent. Relapse from CR: baseline bone marrow blast % return, neutrophils decrease ≥ 50% to \< 1.0x109/L, platelets decrease ≥ 50% to \< 100x109/L, or hemoglobin drop ≥ 1.5 g/dL to \< 10 g/dL, becoming transfusion-dependent. Leukemia transformation: \> 20% blasts per WHO 2016 (Arber et al 2016).
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. 52 months
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice