ASH 2025 | Preliminary results with 7 versus 14-day emavusertib plus aza-ven in AML

So at the last ASH meeting, I presented the preliminary data regarding the phase one trial with emavusertib, which is an oral compound in AML, which is able to inhibit IRAK4 and FLT3. And the clinical trial is designed for patients with AML after at least six courses of azacitidine and venetoclax and still MRD positive. We know very well that MRD is a very important prognostic factor in general in acute leukemias, in ALL, but also in AML. In AML, we don’t have at the moment a drug approved in the setting of MRD in contrast with what we have in ALL. So it’s very, very important to test new approaches in order to try to eradicate minimal residual disease also in these patients. 

In particular, in these patients, the very preliminary data have been presented, ten patients with a newly diagnosed AML treated with azacitidine and venetoclax, with two different schedules, seven or 14 days of emavusertib, in addition to the standard approach with azacitidine and venetoclax, as we usually do in our daily clinical practice. The median age of these patients was 71, and based on the European Leukemia Net risk stratification, two had an adverse AML, five were at intermediate risk, and three had a favorable leukemia. And the preliminary data showed a 50% rate of MRD conversion. So four out of eight patients were able to become MRD negative starting from an MRD positive leukemia. And it was a very, very important result. The safety profile was good. The drug is very well tolerated. Two DLTs were reported. One CPK increase and in the other case neutropenia. The trial is still ongoing – we are waiting for a longer follow-up and for more data regarding more patients in order to draw any conclusion.

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