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SOHO 2025 | Efficacy and safety of olutasidenib monotherapy in relapsed/refractory AML

Jorge Cortes, MD, Georgia Cancer Center, Augusta University, Augusta, GA, discusses the efficacy and safety of olutasidenib monotherapy in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML), highlighting results from a Phase II study (NCT02719574). Dr Cortes notes that the efficacy and safety of this agent were encouraging, making olutasidenib a valuable addition to the treatment armamentarium for patients with IDH1-mutated AML. This interview took place at the 13th Annual Meeting of the Society of Hematologic Oncology (SOHO 2025) in Houston, TX.

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Transcript

Olutasidenib is an IDH1 inhibitor and it’s very potent and it’s like ivosidenib, which is also an IDH1 inhibitor, but it has different biochemical and in vitro properties, like it binds to two sites instead of one. It is much more specific against the IDH-mutated protein rather than the native IDH one. So that makes it attractive. 

And the study where it showed as a single agent in refractory relapsed AML is a very good response rate that is close to 40%...

Olutasidenib is an IDH1 inhibitor and it’s very potent and it’s like ivosidenib, which is also an IDH1 inhibitor, but it has different biochemical and in vitro properties, like it binds to two sites instead of one. It is much more specific against the IDH-mutated protein rather than the native IDH one. So that makes it attractive. 

And the study where it showed as a single agent in refractory relapsed AML is a very good response rate that is close to 40%. But the most attractive thing is, number one, that most of these responses are CRs, only a handful of CRhs, so really we get more of the true CR responses. The second thing is that the response duration and with that the overall survival is very long. It’s almost two years of duration of the remissions, which is very very good in this in this context. 

The drug is fairly safe it has a little bit more of the liver toxicity that we don’t see as much with ivosidenib. Differentiation syndrome is common with these drugs, but it’s generally a very well tolerated drug. So, a very valuable addition to the armamentarium and it’s become very welcome for the management of these patients with IDH1-mutated disease refractory relapsed AML.

 

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