Skip to content
Bending the Curve Trial by Trial
?

Durable remissions with ivosidenib in IDH1-mutated relapsed or refractory AML (phase 1 dose-escalation and expansion)

Phase 1N = 258NCT02074839

Population
IDH1-mutated relapsed or refractory AML, 500 mg daily, primary efficacy population (125 patients)
Design
Phase 1 dose-escalation and dose-expansion study of ivosidenib monotherapy in IDH1-mutated AML; 258 patients treated, 179 with relapsed or refractory AML. The primary efficacy population was 125 patients with relapsed or refractory AML receiving 500 mg daily with at least 6 months of follow-up. Single-arm; no randomized comparator.
Arms
  • Ivosidenib (experimental, n = 125): Ivosidenib 500 mg orally once daily
People
DiNardo CD
Show the numbers
Results reported for Durable remissions with ivosidenib in IDH1-mutated relapsed or refractory AML (phase 1 dose-escalation and expansion)
EndpointAnalysisIvosidenibControlEffect
CR+CRhPrimary efficacy population (125 patients)Complete remission or complete remission with partial hematologic recoveryprimaryDiNardo 201830.4% (22.5–39.3%)—Median duration of response 8.2 months (95% CI 5.5 to 12.0), as stated in the abstract.
CRPrimary efficacy population (125 patients)primaryDiNardo 201821.6% (14.7–29.8%)—Median duration of response 9.3 months (95% CI 5.6 to 18.3), as stated in the abstract.
ORRPrimary efficacy population (125 patients)Overall response rate in relapsed or refractory AML; response criteria are not given in the abstractprimaryDiNardo 201841.6% (32.9–50.8%)—Median duration of response 6.5 months (95% CI 4.6 to 9.3), as stated in the abstract.
Results reported for Durable remissions with ivosidenib in IDH1-mutated relapsed or refractory AML (phase 1 dose-escalation and expansion)
EndpointAnalysisIvosidenibControlEffect
CR+CRhPrimary efficacy population (125 patients)Complete remission or complete remission with partial hematologic recoveryprimaryDiNardo 201830.4% (22.5–39.3%)—Median duration of response 8.2 months (95% CI 5.5 to 12.0), as stated in the abstract.
CRPrimary efficacy population (125 patients)primaryDiNardo 201821.6% (14.7–29.8%)—Median duration of response 9.3 months (95% CI 5.6 to 18.3), as stated in the abstract.
ORRPrimary efficacy population (125 patients)Overall response rate in relapsed or refractory AML; response criteria are not given in the abstractprimaryDiNardo 201841.6% (32.9–50.8%)—Median duration of response 6.5 months (95% CI 4.6 to 9.3), as stated in the abstract.
Primary publication: DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, et al. Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML. N Engl J Med. 2018;378(25):2386-2398. PubMedDOI

Appears in

Sources

  1. DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, et al. Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML. N Engl J Med. 2018;378(25):2386-2398.

    PubMedDOI