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ASH 2025 | HMA maintenance therapy in TP53-mutated AML and MDS improves outcomes of transplantation
David Sallman, MD, Moffitt Cancer Center, Tampa, FL, discusses the controversy surrounding the treatment of TP53-mutated myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), highlighting the need for strategies to improve outcomes of transplantation in patients with high-risk features. Dr Sallman notes that incorporating hypomethylating agent maintenance therapy has led to a doubling of survival in their data, and suggests that this approach warrants further investigation in a pivotal trial. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
Yeah, so P53 mutant MDS and AML is really the molecular subgroup that’s the biggest controversy. Should these patients go to transplant or should they not? If you look at the biggest cohorts across both U.S. and Europe, long-term survival is about 20% and potentially may even be worse in multi-hit or high allele burden patients. Even with some centers, particularly in the U.S., because of insurance rationale not transplanting these patients, granted this is their only curative therapy...
Yeah, so P53 mutant MDS and AML is really the molecular subgroup that’s the biggest controversy. Should these patients go to transplant or should they not? If you look at the biggest cohorts across both U.S. and Europe, long-term survival is about 20% and potentially may even be worse in multi-hit or high allele burden patients. Even with some centers, particularly in the U.S., because of insurance rationale not transplanting these patients, granted this is their only curative therapy. So we really need to have predictors to best optimize, you know, potentially maybe which patients and what can we do to help improve outcomes. So very clearly, you know, there are some rare single-hit patients. They actually do quite well with transplant. I’d say very similar to wild type. But as soon as they’re multi-hit or an allele burden that’s higher, these patients are doing poorly. So what we’ve done now for around the past five years, and we present data with at least two-year survival follow-up, is incorporating relatively universal maintenance early with HMA on both oral or parenteral versions. And in our data, this led to about a doubling of survival and actually one of the largest cohorts presented to date. And this was independent of any of the high-risk features. So we really think the conclusion of our study is that it should strongly support a more pivotal trial looking at HMA maintenance specifically for the P53 mutant subset as far as potentially future incorporation in real-world practice.
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