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Olutasidenib Demonstrates Efficacy for Patients With R/R IDH1-Mutated AML Previously Treated With Venetoclax
Oral olutasidenib, a potent, selective, mutant isocitrate dehydrogenase 1 (mIDH1) inhibitor, demonstrated efficacy and maintained a consistent safety profile as therapy for patients with relapsed/refractory (R/R) mIDH1- acute myeloid leukemia (AML), according to a subgroup analysis from a phase 2, open-label, open-label, non-randomized, non-blinded, multi-cohort, multicenter study.
Investigators explored the efficacy and safety of FDA-approved olutasidenib through an analysis of a subset of adults from 4 cohorts, which included 18 patients with mIDH1 AML. In this group, 10 patients were relapsed, 6 were refractory, and 2 had complete remission with incomplete hematologic recovery (CRi) to a venetoclax combination.
Of the 16 patients who were R/R, 4 (25%) achieved complete remission (CR), 1 (6.3%) achieved CR with partial hematologic recovery, and 7 (43.8%) achieved a composite complete remission. The median time to composite CR was found to be 1.9 months, with a range of 1 to 2.8. As of the data cutoff of 18 June 2021, the median duration of composite CR was not reached, and the range was 1.2 to not reached, with it ongoing at over 30.4 months. Both patients with CRi at study entry achieved a CR. Safety was found to be consistent with the overall profile of olutasidenib
“In light of the limited options and very poor prognosis of patients with AML following failure of venetoclax regimens, olutasidenib represents a valuable therapeutic option for the treatment of this molecularly defined, poor-prognosis patient population,” Jorge Cortes, MD, Georgia Cancer Center, Augusta University, Augusta, Georgia, and coauthors concluded.
Source:
Cortes J, Jonas B, Schiller G, et al. Olutasidenib in post-venetoclax patients with mutant isocitrate dehydrogenase 1 (mIDH1) acute myeloid leukemia (AML). Leuk & Lymph. Published online March 2024. doi: 10.1080/10428194.2024.2333451
