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ASH 2021 | Phase II trial of eprenetapopt plus azacitidine: long-term follow up

Thomas Cluzeau, MD, PhD, Central University Hospital of Nice, Nice, France, outlines the combined Phase II findings from two parallel trials (NCT03072043/NCT03588078) of eprenetapopt (APR-246) in combination with azacitidine in patients with hypomethylating agent (HMA)-naïve TP53-mutant higher risk myelodysplastic syndrome (MDS) or oligoblastic acute myeloid leukemia (AML). An overall response rate of 69% was achieved across the 100 participants, including 43 with a complete response (CR). Isolated TP53 mutations were predictive for a higher CR rate. After a median follow up of 27.8 months, the median overall survival was 11.8 months. Depth of response and measurable residual disease (MRD) status were strongly predictive of overall survival. The combination was well tolerated, with only one treatment discontinuation due to a treatment-related adverse event. This interview took place at during 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.

Transcript (edited for clarity)

So during this ASH Meeting, David Sallman presented the results of the combined Phase II, the US and the French Phase II. We combined the two studies evaluating azacitidine plus eprenetapopt in TP53 MDS and AML patients. Now we have a long follow up combining these two studies, a follow up of more than two years. And we identify that some patients in CR and patients with negative MRD, if these patients were allo-transplanted, they would have a really long survival, because today the median overall survival for these patients was not reached...

So during this ASH Meeting, David Sallman presented the results of the combined Phase II, the US and the French Phase II. We combined the two studies evaluating azacitidine plus eprenetapopt in TP53 MDS and AML patients. Now we have a long follow up combining these two studies, a follow up of more than two years. And we identify that some patients in CR and patients with negative MRD, if these patients were allo-transplanted, they would have a really long survival, because today the median overall survival for these patients was not reached. So as you know the Phase III was not positive, but we think there is a specific subset of patients that could have a good answer after azacitidine plus eprenetapopt. And if the patients could be transplanted maybe we could cure these patients.

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