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ASH 2025 | Which strategies hold promise for treating TP53-mutated MDS?
In this video, David Sallman, MD, Moffitt Cancer Center, Tampa, FL, discusses the path forward for treating TP53-mutated patients with myelodysplastic syndromes (MDS), emphasizing the unmet need for TP53-specific strategies. Dr Sallman mentions the potential of several agents, including small-molecule reactivators like rezatapopt and novel immune therapies such as bexmarilimab. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
I think what’s nice is we fully established we have to have p53 specific strategies. We talked a little bit about pivekimab. There’s also tagraxofusp, which has a little bit of an ongoing expansion of p53, so look forward to that data. I do think we need to look at both durability and survival, more so than just response rates as far as predicting ultimate outcomes but can we have p53 specific therapies? So rezatapopt which again a big pitch this trial is open at MD Anderson, is opening imminently at our center in Sloan Kettering is for Y220C, so only for that variant, which is probably half a percent to one percent of the patient population...
I think what’s nice is we fully established we have to have p53 specific strategies. We talked a little bit about pivekimab. There’s also tagraxofusp, which has a little bit of an ongoing expansion of p53, so look forward to that data. I do think we need to look at both durability and survival, more so than just response rates as far as predicting ultimate outcomes but can we have p53 specific therapies? So rezatapopt which again a big pitch this trial is open at MD Anderson, is opening imminently at our center in Sloan Kettering is for Y220C, so only for that variant, which is probably half a percent to one percent of the patient population. But basically as sort of a monotherapy lead-in in the combination, currently as relapsed, although strongly thinking about it as upfront. Really has had nice activity in solid tumors. This is the first trial in the world that’s ongoing. I would speak to eprenetapopt, you know, I wouldn’t completely lose hope. I think we still need to see the phase three trial and other subgroups of patients, particularly the multi-hit high allele burden patients, which I think we were still learning in that era. So I still would love to sort of resurrect an eprenetapopt concept for, again, this is nice because it’s really for all p53 mutant patients. Again, do we need to focus on a subset? I think hopefully we’ll have some more data on that in 2026. And again, for future novel assets with immune therapies in particular, I think p53 is a key group. I would point the direction to Bexmarilimab, which has an oral presentation by Dr. Zeidan. Again, hard to say relapse data, they are going to move it into frontline, but I’d really be looking at the durability. Could that be the next therapy to also be considered? But I think the key is p53 specific approaches. I think p53 reactivators hopefully will become hot again and maybe novel I-O approaches as well.
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