Jorge E. Cortes, MD, discusses the safety profile of olutasidenib for the treatment of patients with relapsed/refractory acute myeloid leukemia that harbor an IDH1 mutation.
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.
SELECT-AML-1 Trial of Tamibarotene Combo in AML Discontinues Enrollment
August 13th 2024Following a futility analysis, the phase 2 SELECT-AML-1 trial of tamibarotene combined with venetoclax and azacitidine in newly diagnosed RARA-overexpressed acute myeloid leukemia will discontinue enrollment.
Read More
FDA Clears Phase 1 Study of Lomonitinib for R/R AML Treatment in the US
June 10th 2024An investigational new drug application for lomonitinib has been cleared by the FDA for FLT3-mutated relapsed/refractory AML treatment, and a phase 1 trial evaluating the agent will begin in the US.
Read More