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SOHO 2025 | Updated results from the AUGMENT-101 study: revumenib in R/R KMT2A-rearranged or NPM1-mutated AML
Eytan Stein, MD, Memorial Sloan Kettering Cancer Center, New York, NY, presents the updated results from the AUGMENT-101 trial, a study investigating revumenib in relapsed/refractory (R/R) KMT2A-rearranged or NPM1-mutated acute myeloid leukemia (AML). Dr Stein highlights that longer-term results with this agent are encouraging, with no new safety signals and high response and remission rates. However, the durability of response remains low, meaning patients should receive a transplant as soon as possible if they are transplant-eligible. 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
Yeah, so I’m really excited about the AUGMENT-101 study. Just to remind people, AUGMENT-101 is the Phase 1-2 clinical trial of using the menin inhibitor revumenib in patients with relapsed and refractory KMT2A and NPM1 mutant acute leukemia. Revumenib was actually approved for KMT2A-rearranged acute leukemia, this relapsed or refractory, based on AUGMENT-101 and is currently under review by the FDA for approval for NPM1-mutant relapsed and refractory acute myeloid leukemia...
Yeah, so I’m really excited about the AUGMENT-101 study. Just to remind people, AUGMENT-101 is the Phase 1-2 clinical trial of using the menin inhibitor revumenib in patients with relapsed and refractory KMT2A and NPM1 mutant acute leukemia. Revumenib was actually approved for KMT2A-rearranged acute leukemia, this relapsed or refractory, based on AUGMENT-101 and is currently under review by the FDA for approval for NPM1-mutant relapsed and refractory acute myeloid leukemia.
I think the updated results are quite reassuring. I mean, what we look for when we look for longer follow-up is to make sure that no new safety signals have emerged or that the survival has suddenly dropped off dramatically. We don’t see any new safety signals. The drug has the known issue of prolonging the QT interval for which doctors are recommended to carefully assess the electrolytes, the potassium and the magnesium in patients and keep those repleted to a potassium greater than four and a magnesium greater than two. And the other thing that we had seen before was differentiation syndrome; we don’t see an increased risk of differentiation syndrome with longer follow-ups. So that’s reassurance.
Similarly, we’re excited by the results where the remission rates remain quite high in the range of 60% as an overall response rate and a rate of complete remission and complete remission with partial hematologic recovery in the range of 25%. So that’s also exciting. I think the one thing that remains a little bit of a concern with revumenib and with all menin inhibitors is that of the patients who respond, the duration of response is not as long as we want it to be. It is in the range of six months. So if you have a patient on revumenib and they get into remission and they’re a candidate for a stem cell transplant, you really want to try to get them to that stem cell transplant as soon as possible.
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Disclosures
Consulting services: Syndax, Kura, Jansen, Servier.
