Olutasidenib in combination with azacitidine induces durable complete remissions in patients with relapsed or refractory mIDH1 acute myeloid leukemia: a multicohort open-label phase 1/2 trial.

ABSTRACT:

Background

Olutasidenib is a potent, selective, oral, small molecule inhibitor of mutant IDH1 (mIDH1) which induced durable remissions in high-risk, relapsed/refractory (R/R) mIDH1 AML patients in a phase 1/2 trial. We present a pooled analysis from multiple cohorts of the phase 1/2 trial of patients with R/R AML who received combination olutasidenib and azacitidine therapy.

Methods

Adult patients with mIDH1^R132 AML received 150 mg olutasidenib twice daily plus standard-of-care azacitidine (OLU + AZA) and were evaluated for response and safety.

Results

Sixty-seven patients with R/R mIDH1^R132 AML received combination OLU + AZA. Median age was 66 years (range 28-82) and 54% were male. Most patients (83%) had 2 + prior regimens, including a hypometh

SUBMITTER: Cortes JE 

PROVIDER: S-EPMC11736922 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature