ASH 2024 | Olutasidenib alone or in combination with azacitidine in patients with IDH1-mutated MDS

Olutasidenib is a new IDH inhibitor, IDH1 inhibitor, and this is a drug that was developed with a very comprehensive study that included many cohorts both as a single agent and in combination with azacitidine that included patients that had refractory relapse disease, which was the pivotal cohort but some that had prior exposure to IDH inhibitors and some previously untreated and then in the combination also a variety of cohorts. So it is the drug had been already has been approved based on the readout of the pivotal cohort showing that the response rate is high and it is about 35% and mostly these 35% CR/CRh but mostly these are CRs which is very valuable but the probably the most interesting data for these is the durability of the responses and in these analysis what we are showing is how these responses continue being very durable. There’s very few patients that since we first reported these have lost the responses late. So it really confirms the value of this drug. There are some data from preclinical work or non-clinical work that suggests some potential differentiators compared to ivosidenib. it is more specific against IDH1 mutated versus IDH1 native. It binds in two sites instead of one, it overcomes some of the mutations, so there may be some differentiators which is good, you know it’s obviously good to have more than one drug for this indication. The safety profile remains very good, the one thing that we had seen early on was some liver toxicity, there have not been too much more of that with a longer duration of follow-up. And so overall, it shows the continued value of olutasidenib as an alternative for these patients that have refractory relapse disease with an IDH1 mutation.

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