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NCT01915498 · OUTCOME

Phase 2 Dose Expansion: Kaplan-Meier Estimate of Duration of Response

Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation · Source last updated 2024-10-22

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 first dose of study treatment to the data cut-off date of 01 September 2017; median time on follow-up in Phase 2 was 5.8 months (range 0.4 to 22.5 months).

What was measured

For participants with an objective response based on the 2003 revised IWG criteria for AML assessed by the Investigator, duration of response was calculated from the date of the first occurrence of response to the date of documented disease relapse, progression, or death due to any cause, whichever occurred first. Participants without relapse, progressive disease or death were censored at the last response assessment date. Relapse (for participants who previously attained CR, Cri, CRp or MLFS): BM blasts ≥ 5%, reappearance of blasts in the blood or development of extramedullary disease. Disease progression (for participants who previously attained PR): development of new extramedullary disease, or For participants with 5% to 67% BM blasts at nadir: - a \> 50% increase in BM blasts from nadir and that is ≥ 20%. For participants with ≥ 67% BM blasts at nadir: - a doubling of the nadir absolute peripheral blood (PB) blast count and the final absolute PB blast count \> 10 x 10⁹/L.

Analysis population: Participants in Phase 2 with R/R AML who received at least one dose of study treatment and who had an objective response.

Groups in this outcome

Phase 2: Enasidenib 100 mg QD

Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Phase 2: Enasidenib 100 mg QD39

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Enasidenib 100 mg QD5.6Not reported3.77.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.7
        upper Limit
        7.4
        value
        5.6
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
description
For participants with an objective response based on the 2003 revised IWG criteria for AML assessed by the Investigator, duration of response was calculated from the date of the first occurrence of response to the date of documented disease relapse, progression, or death due to any cause, whichever occurred first. Participants without relapse, progressive disease or death were censored at the last response assessment date. Relapse (for participants who previously attained CR, Cri, CRp or MLFS): BM blasts ≥ 5%, reappearance of blasts in the blood or development of extramedullary disease. Disease progression (for participants who previously attained PR): development of new extramedullary disease, or For participants with 5% to 67% BM blasts at nadir: - a \> 50% increase in BM blasts from nadir and that is ≥ 20%. For participants with ≥ 67% BM blasts at nadir: - a doubling of the nadir absolute peripheral blood (PB) blast count and the final absolute PB blast count \> 10 x 10⁹/L.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG000
    title
    Phase 2: Enasidenib 100 mg QD
param Type
MEDIAN
population Description
Participants in Phase 2 with R/R AML who received at least one dose of study treatment and who had an objective response.
reporting Status
POSTED
time Frame
From first dose of study treatment to the data cut-off date of 01 September 2017; median time on follow-up in Phase 2 was 5.8 months (range 0.4 to 22.5 months).
title
Phase 2 Dose Expansion: Kaplan-Meier Estimate of Duration of Response
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice