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EHA 2026 | Real-world data support olutasidenib after venetoclax in IDH1-mutated AML
Pinkal Desai, MD, MPH, Weill Cornell Medicine, New York, NY, reviews real-world outcomes with olutasidenib in patients with relapsed/refractory (R/R) IDH1-mutated acute myeloid leukemia (AML) previously treated with venetoclax, highlighting encouraging response rates, durable remissions, and the potential role of this targeted therapy in current treatment sequencing. This interview took place at the 31st Congress of the European Hematology Association (EHA) in Stockholm, Sweden.
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Transcript
So at ASH we presented our abstract on the real-world use of olutasinib post-venetoclax. And as we know, olutasinib is approved in the relapsed refractory setting. And the trial, the phase two trial that led to its approval was interesting because the duration of response was actually really long, 24 months. And one of the challenges that we were, you know, sort of trying to look for is that does this actually maintain itself in the real-world setting, so that was the intent of the abstract and we took it as a chart review of nine academic and nine community hospitals, so it was a mixed bag...
So at ASH we presented our abstract on the real-world use of olutasinib post-venetoclax. And as we know, olutasinib is approved in the relapsed refractory setting. And the trial, the phase two trial that led to its approval was interesting because the duration of response was actually really long, 24 months. And one of the challenges that we were, you know, sort of trying to look for is that does this actually maintain itself in the real-world setting, so that was the intent of the abstract and we took it as a chart review of nine academic and nine community hospitals, so it was a mixed bag. And they all had to have failed venetoclax. So it was a relapse after venetoclax use. Obviously, any other IDH inhibitors was not allowed in terms of the exposure. And what was interesting, two things, is the CRcRH rate, which is an important indicator of clinical benefit, was actually 60%, which is much higher than what was even observed in the clinical trials. And if you count the morphologic leukemia-free state, which we sometimes debate whether that’s a response or not, then it was almost 90%. But it was just purely thinking CR, CRh, it was 60%. And the duration of response was actually 34 months, so it was sustained. So this is very much validating what the phase two studies were showing that there is a sustained response. This is important because in the time when these IDH inhibitors were approved, nobody was at that time being treated with venetoclax as a frontline management. So the population we’re seeing now are the people who have already seen venetoclax. So having data on can you use olutasinib in this setting with a CRcRH of 60% and a duration of 34 months, this is looking very good. So I think the intent of the study was in the real world setting. Also, these responses are being observed and they’re in fact better than what the phase two trial that led to its approval.
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