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NCT01915498 · OUTCOME

Phase 1 Dose Expansion: Kaplan-Meier Estimate of Duration of Complete Response (DOCR)

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; overall median time on follow-up in Phase 1 Dose Expansion was 8.3 months (range 0.5 to 32.8 months).

What was measured

Among participants who had a response of CR based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS assessed by the Investigator, duration of complete response was calculated from the date of the first occurrence of complete response to the date of documented disease relapse, progression or death, whichever occurred earlier. DOCR was estimated using the Kaplan-Meier method. Participants without relapse, progressive disease, or death due to any cause were censored at the date of the last adequate response assessment.

Analysis population: Participants who received at least one dose of study treatment in Phase 1 Dose Expansion with a complete response.

Groups in this outcome

Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD

Participants ≥ 60 years old with relapsed, refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD

Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD

Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD

Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib 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 1 Dose Expansion Arm 1: Enasidenib 100 mg QD11
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD0
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD5
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD6

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD11.6Not reported1.9NANot estimable due to low number of events
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QDNANot reported3.7NANot estimable due to low number of events
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD16.8Not reported2.6NANot estimable due to low number of events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to low number of events
        group Id
        OG000
        lower Limit
        1.9
        upper Limit
        NA
        value
        11.6
      2. comment
        Not estimable due to low number of events
        group Id
        OG002
        lower Limit
        3.7
        upper Limit
        NA
        value
        NA
      3. comment
        Not estimable due to low number of events
        group Id
        OG003
        lower Limit
        2.6
        upper Limit
        NA
        value
        16.8
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      6
    units
    Participants
description
Among participants who had a response of CR based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS assessed by the Investigator, duration of complete response was calculated from the date of the first occurrence of complete response to the date of documented disease relapse, progression or death, whichever occurred earlier. DOCR was estimated using the Kaplan-Meier method. Participants without relapse, progressive disease, or death due to any cause were censored at the date of the last adequate response assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants ≥ 60 years old with relapsed, refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib 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 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
  2. description
    Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG001
    title
    Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
  3. description
    Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG002
    title
    Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
  4. description
    Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    OG003
    title
    Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
param Type
MEDIAN
population Description
Participants who received at least one dose of study treatment in Phase 1 Dose Expansion with a complete response.
reporting Status
POSTED
time Frame
From first dose of study treatment to the data cut-off date of 01 September 2017; overall median time on follow-up in Phase 1 Dose Expansion was 8.3 months (range 0.5 to 32.8 months).
title
Phase 1 Dose Expansion: Kaplan-Meier Estimate of Duration of Complete Response (DOCR)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice