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ASH 2025 | Datasets at ASH 2025 that will refine the management of FLT3-mutated AML

Mark Levis, MD, PhD, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, shares insights into datasets that will refine the management of FLT3-mutated acute myeloid leukemia (AML) in both the frontline and relapsed/refractory settings. He highlights the VICEROY trial (NCT05520567), as well as a trial of azacitidine plus venetoclax versus 7 plus 3. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.

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Transcript

Both settings, I would say, the data from the VICEROY trial, which is being presented orally at this meeting, will offer insight. I’m not sure how much they’re going to refine it. That trial is AZA plus VEN plus gilteritinib, the so-called triple. And the data suggest that it is an effective approach, certainly in the relapsed/refractory setting, but this is for upfront and that’s a more debatable matter...

Both settings, I would say, the data from the VICEROY trial, which is being presented orally at this meeting, will offer insight. I’m not sure how much they’re going to refine it. That trial is AZA plus VEN plus gilteritinib, the so-called triple. And the data suggest that it is an effective approach, certainly in the relapsed/refractory setting, but this is for upfront and that’s a more debatable matter. But putting the data out there, everybody is very interested in this particular combination, how to use it, how to use it safely and effectively. And so I think that’s going to be one of the bigger impacts. But the other honest data set that’s going to turn the field upside down is at the plenary session, where Amir Fathi is going to present the results of the randomized trial between AZA-VEN and 7 plus 3. And although FLT3 mutant patients were excluded, simply substituting intensive therapy for AZA-VEN is going to turn the whole field upside down, potentially for FLT3 as well. Because we have the VICEROY that says, oh, add gilteritinib to AZA-VEN. AZA-VEN is just as good as intensive therapy. The whole field has been a bit scrambled. So I think it’ll be interesting to see how we are going forward.

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