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NCT02610777 · OUTCOME

Duration of Overall Response

An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML) · Source last updated 2022-09-19

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
From date of randomization until CR, PR or HI (up to approximately 5 years)

What was measured

Duration of OR: response to first documentation of PD or relapse from CR for low-blast AML or relapse after CR or PR for HR MDS/CMML. Disease responses(HR MDS/CMML): modified IWG criteria for MDS;low-blast AML: revised IWG criteria for AML.Overall response(HR MDS/CMML)=CR,PR/HI,LB AML=CR+ Cri+PR.HR MDS/CMML-CR:≤5%myeloblasts with normal maturation of BM cell lines,≥11g/dL Hb,≥100\*10\^9/L plt,≥1.0\*10\^9/L ANC,0%blasts in peripheral blood; PR:CR criteria met except BM blasts≥50%less over pretreatment but still\>5%; HI:hb increase(inc)≥1.5g/dL if baseline\<11g/dL; plt inc≥30\*10\^9/L if baseline \>20\*10\^9/L inc from\<20\*10\^9/L-\>20\*10\^9/L,ANC inc by100%; absolute inc of \>0.5\*10\^9/L if baseline \<100\*10\^9/L.LB AML-CR: morphologic leukemia-freestate \>1.0\*10\^9 ANC,≥100\*1 \^9/Lplt, transfusion independence, no residual evidence of extramedullary leukemia; CRi:fulfill CR criteria except residual neutropenia\<1.0\*10\^9/L/TTP\<100\*10\^9/L; PR:all CR hematological values but\>=50%less in BM aspirate.

Analysis population: REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. Data is reported for overall responders.

Groups in this outcome

Azacitidine 75 mg/m^2

Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).

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

Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).

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^233
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^239

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^214.0Not reported12.62NAThe upper limit of full range was not estimable due to lower number of participants with the event.
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^220.6Not reported10.71NAThe upper limit of full range was not estimable due to lower number of participants with the event.

Source statistical analyses

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

  1. ci Lower Limit
    0.395
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.662
    estimate Comment
    Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.565
    p Value Comment
    P-value is from an unstratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.810
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.395
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.662
    estimate Comment
    Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.565
    p Value Comment
    P-value is from an unstratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.810
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of full range was not estimable due to lower number of participants with the event.
        group Id
        OG000
        lower Limit
        12.62
        upper Limit
        NA
        value
        14.0
      2. comment
        The upper limit of full range was not estimable due to lower number of participants with the event.
        group Id
        OG001
        lower Limit
        10.71
        upper Limit
        NA
        value
        20.6
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    2. group Id
      OG001
      value
      39
    units
    Participants
description
Duration of OR: response to first documentation of PD or relapse from CR for low-blast AML or relapse after CR or PR for HR MDS/CMML. Disease responses(HR MDS/CMML): modified IWG criteria for MDS;low-blast AML: revised IWG criteria for AML.Overall response(HR MDS/CMML)=CR,PR/HI,LB AML=CR+ Cri+PR.HR MDS/CMML-CR:≤5%myeloblasts with normal maturation of BM cell lines,≥11g/dL Hb,≥100\*10\^9/L plt,≥1.0\*10\^9/L ANC,0%blasts in peripheral blood; PR:CR criteria met except BM blasts≥50%less over pretreatment but still\>5%; HI:hb increase(inc)≥1.5g/dL if baseline\<11g/dL; plt inc≥30\*10\^9/L if baseline \>20\*10\^9/L inc from\<20\*10\^9/L-\>20\*10\^9/L,ANC inc by100%; absolute inc of \>0.5\*10\^9/L if baseline \<100\*10\^9/L.LB AML-CR: morphologic leukemia-freestate \>1.0\*10\^9 ANC,≥100\*1 \^9/Lplt, transfusion independence, no residual evidence of extramedullary leukemia; CRi:fulfill CR criteria except residual neutropenia\<1.0\*10\^9/L/TTP\<100\*10\^9/L; PR:all CR hematological values but\>=50%less in BM aspirate.
dispersion Type
Full Range
groups
  1. description
    Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
    id
    OG000
    title
    Azacitidine 75 mg/m^2
  2. description
    Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
    id
    OG001
    title
    Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
param Type
MEDIAN
population Description
REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. Data is reported for overall responders.
reporting Status
POSTED
time Frame
From date of randomization until CR, PR or HI (up to approximately 5 years)
title
Duration of Overall Response
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice