|The following article features coverage from the European Hematology Association (EHA) 2021 Virtual Congress. Click here to read more of Hematology Advisor‘s conference coverage.|
Among patients with relapsed/refractory, IDH1-mutated acute myeloid leukemia (AML), olutasidenib may induce durable complete responses (CRs), according to research presented at the European Hematology Association (EHA) 2021 Virtual Congress.
A previous phase 1 study suggested that olutasidenib — a selective, orally administered inhibitor of mutated IDH1 — may improve outcomes among high-risk patients with AML. In this presentation, researchers reported an interim analysis of a phase 2 trial (ClinicalTrials.gov Identifier: NCT02719574) that evaluated the safety and efficacy of olutasidenib among patients with relapsed/refractory, IDH2-mutated disease.
All enrolled and treated patients received olutasidenib 150 mg twice daily. The primary analysis endpoint was CR and CR with partial hematological recovery (CRh), defined as bone marrow blasts less than 5%, a neutrophil count greater than 0.5×109/L, and a platelet count greater than 50×109/L.
Overall, 153 patients were enrolled and received olutasidenib, with a median duration of therapy of 5.5 months. At data cutoff, 110 (72%) patients had discontinued therapy, primarily because of disease progression (31%), adverse events (AEs; 14%), transplant (8%), and death (10%).
The authors stated that the study met its predefined efficacy target in the evaluable population, which consisted of 123 patients. In this group, the median age was 71 years (range, 32-87) and the median number of prior therapy lines was 2 (range, 1-7).
The overall response rate (defined as a partial response or better) was 46%, with a median response duration of 11.7 months. The rate of both CRs and CRhs was 33%, and 30% of patients had a CR. A sensitivity analysis suggested that the duration of CR/CRh was 13.8 months.
Transfusion-dependent patients at baseline who had a CR or CRh to therapy had a platelet transfusion-independent improvement of 100% vs 56% among those without a CR or CRh.
The median overall survival was 10.5 months in the overall cohort and not reached among patients with a CR or CRh.
Grade 3/4 AEs observed in more than 10% of patients included febrile neutropenia (20%), anemia (19%), thrombocytopenia (16%), and neutropenia (13%). The most common treatment-related AEs overall were febrile neutropenia (20%), anemia (19%), thrombocytopenia (16%), and neutropenia (13%).
IDH1 differentiation syndrome of any grade was noted in 14% of patients, with 1 fatal case.
Disclosure: The presenter declared affiliations with Astellas Pharma, Aiichi Sankyo, Seagen, AbbVie, Bayer, Syros Pharmaceuticals, Forma Therapeutics, Inc., Janssen-Cilag, Pfizer, Agios, Celgene, Jazz Pharmaceuticals, and Novartis.
Read more of Cancer Therapy Advisor’s coverage of the EHA 2021 Virtual Congress by visiting the conference page.
de Botton S, Yee K, Christian R, et al. Effect of olutasidenib (FT-2102) on complete remissions in patients with relapsed/refractory mutant IDH1 acute myeloid leukemia. results from a planned interim analysis of a phase 2 clinical trial. Paper presented at: European Hematology Association 2021 Virtual Congress; June 2021; Abstract S138.
This article originally appeared on Cancer Therapy Advisor