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NCT03268954 · OUTCOME

Time to Progressive Disease (PD), Relapse After CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death

Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) · Source last updated 2025-10-29

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
From randomization until PD, relapse after CR, or relapse after CR or PR, or death due to any cause, whichever occurs first (up to approximately 42 months)

What was measured

Time to PD, relapse after CR(low-blast AML), relapse after CR or PR(HR MDS/CMML), or death,defined as time from date of randomization until date of first documentation of PD,relapse after CR(low-blast AML),relapse after CR or PR(HR MDS/CMML),or death due to any cause, whichever occurs first. In HR MDS/CMML,PD: Participants with\<5% blasts:\>=50% inc \>5% blasts, with 5%-9% blasts:\>=50% inc\>10% blasts, with 10%-19% blasts:\>=50% inc \>20% blasts,with 20%-30% blasts, at least 50% decrement from maximum remission/response in granulocytes or pl or reduction in Hgb by\>=2 g/dL/new transfusion dependence.Relapse after CR or PR: return to pretreatment bone marrow blast %/Decrement of \>=50% from maximum remission/response levels in granulocytes/pl/reduction in Hgb conc.\>=1.5 g/dL/transfusion dependence. In AML,PD:\>50% inc in bone marrow blasts to \>30% blasts,\>50% inc in circulating blasts to\>30% blasts in peripheral blood, Development of extramedullary disease/new sites of extramedullary leukemia.

Analysis population: ITT Population included all participants who were randomized.

Groups in this outcome

Azacitidine 75 mg/m^2

Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.

Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2

Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.

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

Analysis denominator · Participants

GroupSource count
Azacitidine 75 mg/m^2227
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2227

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^211.8Not reported10.2513.31Not reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^213.1Not reported11.0115.84Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.689
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.067
    estimate Comment
    Hazard ratio was based on a stratified Cox proportional hazard regression model stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML, with treatment as a factor in the model.
    group Description
    Time to Progressive Disease (PD), Relapse after CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.084
    p Value Comment
    P-value was obtained from a stratified 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.
    param Type
    Hazard Ratio (HR)
    param Value
    0.858
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.689
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.067
    estimate Comment
    Hazard ratio was based on a stratified Cox proportional hazard regression model stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML, with treatment as a factor in the model.
    group Description
    Time to Progressive Disease (PD), Relapse after CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.084
    p Value Comment
    P-value was obtained from a stratified 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.
    param Type
    Hazard Ratio (HR)
    param Value
    0.858
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.25
        upper Limit
        13.31
        value
        11.8
      2. group Id
        OG001
        lower Limit
        11.01
        upper Limit
        15.84
        value
        13.1
denoms
  1. counts
    1. group Id
      OG000
      value
      227
    2. group Id
      OG001
      value
      227
    units
    Participants
description
Time to PD, relapse after CR(low-blast AML), relapse after CR or PR(HR MDS/CMML), or death,defined as time from date of randomization until date of first documentation of PD,relapse after CR(low-blast AML),relapse after CR or PR(HR MDS/CMML),or death due to any cause, whichever occurs first. In HR MDS/CMML,PD: Participants with\<5% blasts:\>=50% inc \>5% blasts, with 5%-9% blasts:\>=50% inc\>10% blasts, with 10%-19% blasts:\>=50% inc \>20% blasts,with 20%-30% blasts, at least 50% decrement from maximum remission/response in granulocytes or pl or reduction in Hgb by\>=2 g/dL/new transfusion dependence.Relapse after CR or PR: return to pretreatment bone marrow blast %/Decrement of \>=50% from maximum remission/response levels in granulocytes/pl/reduction in Hgb conc.\>=1.5 g/dL/transfusion dependence. In AML,PD:\>50% inc in bone marrow blasts to \>30% blasts,\>50% inc in circulating blasts to\>30% blasts in peripheral blood, Development of extramedullary disease/new sites of extramedullary leukemia.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
    id
    OG000
    title
    Azacitidine 75 mg/m^2
  2. description
    Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
    id
    OG001
    title
    Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2
param Type
MEDIAN
population Description
ITT Population included all participants who were randomized.
reporting Status
POSTED
time Frame
From randomization until PD, relapse after CR, or relapse after CR or PR, or death due to any cause, whichever occurs first (up to approximately 42 months)
title
Time to Progressive Disease (PD), Relapse After CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice