Safety of Olutasidenib in IDH1-Mutated R/R AML

Jorge E. Cortes, MD, director of the Georgia Cancer Center at Augusta University, discusses the safety profile of olutasidenib (Rezlidhia) for the treatment of patients with relapsed/refractory acute myeloid leukemia (AML) that harbor an IDH1 mutation.

Data come from phase 1/2 Study 2102-HEM-101 (NCT02719574) and showed that in the open-label, multicenter trial, olutasidenib was overall safe with high levels of response. 

Any grade adverse events (AEs) observed with the drug were manageable, and included differentiation syndrome (14%), leukocytosis (13%), alanine aminotransaminase increases (8%), constipation (8%), fatigue (7%), vomiting (7%), anemia (6%).

TRANSCRIPTION:

0:10 | The drug has been very safe, not much in terms of toxicity. Some elements that are important to highlight [included] differentiation syndrome, as we do see that's a mechanism of action related safety profile. But in general, with close monitoring, the great majority of these [adverse events (AEs)], and these were less than 15% of patients who had these, and most of them were managed with treatment interruptions or corticosteroids, or hydroxyurea, and the majority of patients were able to be managed well.

0:46 | We don't see QTc-prolongation to any significant extent with these drugs, so it doesn't have that problem. There is some liver toxicity in 20% of the patients, but the great majority of these can be managed, again, with treatment interruptions or dose adjustments. [Moreover], there were only a handful of patients that had to discontinue because of liver toxicity.

1:11 | Overall, this is a drug with high levels of response, with durable responses, very good overall survival, and with a very good safety profile.

REFERENCE

Cortes J, Fenaux P, Yee, K, et al. Olutasidenib (FT-2102) induces durable complete remissions in patients with relapsed/refractory mIDH1 acute myeloid leukemia. Results from a planned interim analysis of a phase 2 pivotal clinical trial. Blood. 2022;140(suppl 1):6193-6196. doi:10.1182/blood-2022-167330