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ASH 2025 | HMAs and venetoclax in MDS following VERONA: lessons from a negative Phase III trial
In this video, David Sallman, MD, Moffitt Cancer Center, Tampa, FL, discusses the role of hypomethylating agents (HMAs) and venetoclax combinations in higher-risk myelodysplastic syndromes (HR-MDS). He notes that despite negative results from the Phase III VERONA trial (NCT04401748), real-world data suggest that this combination may benefit certain patient subsets. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
Yeah, so I think unfortunately, you know, we cry again with another negative phase three trial. The Verona trial, of course, originally read out at ASH in September, but we do have another oral presentation followed by Dr Garcia-Manero. I’m looking forward to actually looking at a lot of the subset data. I’m hoping we’ll see more data on mutant versus wild-type, increased blasts versus as well as potentially outcomes to transplant...
Yeah, so I think unfortunately, you know, we cry again with another negative phase three trial. The Verona trial, of course, originally read out at ASH in September, but we do have another oral presentation followed by Dr Garcia-Manero. I’m looking forward to actually looking at a lot of the subset data. I’m hoping we’ll see more data on mutant versus wild-type, increased blasts versus as well as potentially outcomes to transplant. I think that being said we’ve now all extensively used HMA venetoclax in real-world data. I think there’s at least four large cohorts being presented at this meeting, including an oral presentation that we’re a major contributor for. I think in p53 wild-type HMA venetoclax, particularly for excess blasts and certain molecular subsets like ASXL1, is still a game changer and is truly majorly increasing responses. I think you have to optimize venetoclax. I think you need to think carefully about patients that may go to transplant versus not. And so I still think there’s a major role for venetoclax. Maybe there’s a number of new BCL2 inhibitors that may have differences, half-life, et cetera. And so I think for the way forward, we need to do smarter trials, maybe, again, mutant versus wild-type, and again, optimizing really the patient demographics that may be best suited for the response. It clearly has a role, and I think these data are pushing maybe how we should think about it, particularly for groups like ASXL1.
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