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Olutasidenib (FT-2102) in relapsed or refractory IDH1-mutated AML (pivotal cohort of a phase 1/2 study)

Phase 1/2N = 153NCT02719574

Population
IDH1 inhibitor-naive relapsed or refractory AML with an IDH1 R132 mutation (median age 71 years, range 32 to 87)
Design
Pivotal cohort of a multicenter, open-label phase 1/2 study; olutasidenib 150 mg twice daily in IDH1 inhibitor-naive patients with mIDH1 R132 relapsed or refractory AML. Single-arm; no randomized comparator. ClinicalTrials.gov lists 336 participants for the whole study.
Arms
  • Olutasidenib (experimental, n = 153): Olutasidenib 150 mg orally twice daily
People
de Botton S
Show the numbers
Results reported for Olutasidenib (FT-2102) in relapsed or refractory IDH1-mutated AML (pivotal cohort of a phase 1/2 study)
EndpointAnalysisOlutasidenibControlEffect
CR+CRhEfficacy-evaluable population (n = 147 of the 153 treated; first dose at least 6 months before data cut-off)Complete remission or complete remission with partial hematologic recoveryprimaryde 202335% (27–43%)—Median duration of CR/CRh 25.9 months with 55% of patients censored at data cut-off, as stated in the abstract.
ORREfficacy-evaluable population (n = 147 of the 153 treated; first dose at least 6 months before data cut-off)Overall response rate in relapsed or refractory AML; response criteria are not given in the abstractprimaryde 202348% (40.0–56.7%)—Median duration of overall response 11.7 months, as stated in the abstract.
OSFull analysis population (all 153 treated patients)primaryde 2023median 11.6 months (8.9–15.5)——
Results reported for Olutasidenib (FT-2102) in relapsed or refractory IDH1-mutated AML (pivotal cohort of a phase 1/2 study)
EndpointAnalysisOlutasidenibControlEffect
CR+CRhEfficacy-evaluable population (n = 147 of the 153 treated; first dose at least 6 months before data cut-off)Complete remission or complete remission with partial hematologic recoveryprimaryde 202335% (27–43%)—Median duration of CR/CRh 25.9 months with 55% of patients censored at data cut-off, as stated in the abstract.
ORREfficacy-evaluable population (n = 147 of the 153 treated; first dose at least 6 months before data cut-off)Overall response rate in relapsed or refractory AML; response criteria are not given in the abstractprimaryde 202348% (40.0–56.7%)—Median duration of overall response 11.7 months, as stated in the abstract.
OSFull analysis population (all 153 treated patients)primaryde 2023median 11.6 months (8.9–15.5)——
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Olutasidenib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsOlutasidenib
0100.0%
765.8%
1540.8%
2226.9%
2917.7%
Primary publication: de Botton S, Fenaux P, Yee K, Récher C, Wei AH, Montesinos P, et al. Olutasidenib (FT-2102) induces durable complete remissions in patients with relapsed or refractory IDH1-mutated AML. Blood Adv. 2023;7(13):3117-3127. PubMedDOI

Appears in

Sources

  1. de Botton S, Fenaux P, Yee K, Récher C, Wei AH, Montesinos P, et al. Olutasidenib (FT-2102) induces durable complete remissions in patients with relapsed or refractory IDH1-mutated AML. Blood Adv. 2023;7(13):3117-3127.

    PubMedDOI