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ASH 2025 | Ven+FluBu2 with PTCy/Tac/MMF RIC transplant followed by Ven/Aza maintenance for high-risk MDS/AML
H. Moses Murdock, MD, Dana Farber Cancer Institute, Boston, MA, discusses the findings from a Phase I trial (NCT03613532) investigating the use of venetoclax plus fludarabine/busulfan (Ven+FluBu2) reduced-intensity conditioning (RIC) with post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF), followed by venetoclax and azacitidine (Ven/Aza) maintenance in patients with high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So we know that allogeneic transplantation is the only curative treatment option for older patients with high-risk MDS and AML, but unfortunately relapse is the main cause of transplant failure and death for these patients. So with my mentor Dr. Garcia at Dana-Farber, we aimed to augment or improve conditioning chemotherapy by adding venetoclax to that pre-donor stem cell infusion chemotherapy...
So we know that allogeneic transplantation is the only curative treatment option for older patients with high-risk MDS and AML, but unfortunately relapse is the main cause of transplant failure and death for these patients. So with my mentor Dr. Garcia at Dana-Farber, we aimed to augment or improve conditioning chemotherapy by adding venetoclax to that pre-donor stem cell infusion chemotherapy. And then, assuming patients did well after the transplant, to give them further relapse-mitigating treatment in the form of azacitidine and venetoclax as maintenance for approximately one year after transplantation.
So in this very high-risk cohort, 50% of whom had biallelic TP53 mutations, which we know confer an exceedingly high risk of relapse, the one-year survival was approximately 60%. Relapse remained the biggest factor that led to death, unfortunately still, in about 50% of patients. But overall, we found that it was feasible and safe to give this augmented RIC conditioning and post-transplant maintenance. We did note infections which have been noted with post-transplant cyclophosphamide-based GVHD prophylaxis. And we also found that compared to our tacrolimus methotrexate cohort, there was a trend to taking a little bit longer to get to maintenance and that a slightly fewer percentage of patients were able to get to maintenance. Clearly, these results need to be validated in randomized trials to see if this is something that is feasible, safe, and effective in the real world. There are ongoing efforts through cooperative groups, MyelomaMatch, to test these hypotheses and hopefully bring this forward into standard of care if it proves to be efficacious.
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