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SOHO 2025 | TP53-mutated MDS & AML: a key unmet need & the value of enrolling patients in clinical trials
David Sallman, MD, Moffitt Cancer Center, Tampa, FL, comments on the challenges associated with TP53-mutated myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Dr Sallman highlights the need for novel treatment approaches and the importance of accurately identifying patients and enrolling them in clinical trials. This interview took place at the 13th Annual Meeting of the Society of Hematologic Oncology (SOHO 2025) in Houston, TX.
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Transcript
So I think unfortunately p53 mutant patients don’t respond well to any therapy and i think a lot of us would argue that unfortunately as of right now we don’t really have a standard of care therapy and even the FDA has been on board with that so for example the ENHANCE-2 trial which was the p53 AML trial of aza-magro versus aza-ven or induction chemo was independent of fitness or age and it was investigator discretion as far as what control arm that you chose...
So I think unfortunately p53 mutant patients don’t respond well to any therapy and i think a lot of us would argue that unfortunately as of right now we don’t really have a standard of care therapy and even the FDA has been on board with that so for example the ENHANCE-2 trial which was the p53 AML trial of aza-magro versus aza-ven or induction chemo was independent of fitness or age and it was investigator discretion as far as what control arm that you chose. I think where we’ve come is we know how to recognize this group of patients. We should really make a singular disease entity across MDS and AML for p53 with multi-hit. This is probably around 90% of patients, at least at academic cohorts, maybe a little bit less in community cohorts. So we can recognize them. We know we can rapidly enroll these patients on trial. And I think really the most important message that all of these patients need to go on trial because the standard of care is clearly not adequate.
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Disclosures
Consultancy: AbbVie, Agios, Debiopharm, Janssen, Johnson & Johnson, Molecular Partners, Novartis
Advisory Board: AbbVie, Agios, Astellas, AvenCell, Bristol-Myers Squibb, BlueBird Bio, Dark Blue Therapeutics, Geron, Novartis, Shattuck Labs, Servier, Syndax, Syros, Taiho Oncology
Research Funding: Aprea, Jazz
