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EHA 2025 | BEAT AML trial update: revumenib + aza-ven in older adults with NPM1-mutated or KMT2A-rearranged AML
Joshua Zeidner, MD, UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC, presents the updated results from the Beat AML Master trial (NCT03013998), a study investigating the safety and efficacy of azacitidine (aza), venetoclax (ven), and revumenib in newly diagnosed older adults with NPM1-mutated or KMT2A-rearranged acute myeloid leukemia (AML). The encouraging safety and clinical activity of this regimen led to the design of the ongoing EVOLVE-2 pivotal frontline trial (NCT06652438), which could deliver potentially practice-changing results. This interview took place at the 30th Congress of the European Hematology Association (EHA) in Milan, Italy.
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Transcript
So we designed the Phase Ib study of azacitidine, venetoclax, and the addition of an investigational menin inhibitor, revumenib, to the backbone of standard frontline AZA-VEN for newly diagnosed older unfit patients with an NPM1 mutation or KMT2A rearrangement. I think there’s several findings from our study that we presented on Thursday at the European Hematology Association Congress, and this is now subsequently published in the Journal of Clinical Oncology...
So we designed the Phase Ib study of azacitidine, venetoclax, and the addition of an investigational menin inhibitor, revumenib, to the backbone of standard frontline AZA-VEN for newly diagnosed older unfit patients with an NPM1 mutation or KMT2A rearrangement. I think there’s several findings from our study that we presented on Thursday at the European Hematology Association Congress, and this is now subsequently published in the Journal of Clinical Oncology.
The first notable finding is that it was safe to escalate Revumenib at both dose levels. We started at dose level one, escalated to dose level two, did not see any dose-limiting toxicities. The regimen was overall safe and feasible to administer in this population.
The second important finding, of course, is that this was a highly active regimen. We saw complete remission rates of 67%, overall response rates in the 88 to 90 percent range and this was in both NPM1 mutated patients as well as KMT2A rearrangements. Our overall survival analysis is a bit short with follow-up and we’re still analyzing our data of the 43 patient cohort that we’ve enrolled so far but the results are incredibly exciting to us and has led to the design and development of a randomized Phase III study known as Evolve 2, and this is going to be comparing azacitidine, venetoclax, and Revumenib versus azacitidine, venetoclax, and placebo in this newly diagnosed older unfit population with an NPM1 mutation or a KMT2A rearrangement. We hope that these results will you know be practice changing and can change the standard of care for this population. We’re interested in obviously having further follow-up of patients on this study and we’re enrolling more patients to really fully determine, you know, which patient subsets, you know, might really benefit from this regimen. And what are the mechanisms of resistance and relapse that can happen after patients achieve a response on this regimen?
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