NCT03268954 · OUTCOME

Overall Survival (OS)

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: Up to approximately 6.9 years

What was measured

Overall survival was defined as the time from randomization to death from any cause.

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

Group	Source count
Azacitidine 75 mg/m^2	227
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2	227

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Azacitidine 75 mg/m^2	16.8	Not reported	14.92	20.11	Not reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2	20.3	Not reported	17.97	22.60	Not reported

Source statistical analyses

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

ci Lower Limit
0.709
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.113
estimate Comment
HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1: longer survival time in combination arm than azacitidine arm.
group Description
Overall Survival (OS)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.152
p Value Comment
P-value comparing OS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.
param Type
Hazard Ratio (HR)
param Value
0.888
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.709
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.113
estimate Comment
HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1: longer survival time in combination arm than azacitidine arm.
group Description
Overall Survival (OS)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.152
p Value Comment
P-value comparing OS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.
param Type
Hazard Ratio (HR)
param Value
0.888
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
14.92
upper Limit
20.11
value
16.8
group Id
OG001
lower Limit
17.97
upper Limit
22.60
value
20.3

denoms

counts
group Id
OG000
value
227
group Id
OG001
value
227
units
Participants

description

Overall survival was defined as the time from randomization to death from any cause.

dispersion Type

95% Confidence Interval

groups

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
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

Up to approximately 6.9 years

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice