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ASH 2025 | Ziftomenib with azacitidine and venetoclax in NPM1-mutated AML: the KOMET-007 trial
Amer Zeidan, MBBS, MHS, Yale University and Yale Cancer Center, New Haven, CT, discusses the promising results from the ongoing KOMET-007 trial (NCT05735184) evaluating ziftomenib in combination with azacitidine and venetoclax (aza-ven) in newly diagnosed and relapsed/refractory (R/R) NPM1-mutated acute myeloid leukemia (AML). Dr Zeidan notes that the combination is well-tolerated and has led to the initiation of a randomized Phase III trial, KOMET-017 (NCT07007312), which will investigate the efficacy of ziftomenib with 7+3 or aza-ven in previously untreated NPM1-mutated or KMT2A-rearranged AML. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
Ziftomenib is an oral menin inhibitor that actually just got approved in the U.S. a month ago in the relapsed/refractory setting for patients with NPM1-mutated refractory/relapsed acute myeloid leukemia. And the drug is now being tested in the frontline setting in different combinations. So we are presenting from the KOMET-007 study which is looking at adding ziftomenib to aza-ven in the frontline setting as well as adding ziftomenib to 7+3...
Ziftomenib is an oral menin inhibitor that actually just got approved in the U.S. a month ago in the relapsed/refractory setting for patients with NPM1-mutated refractory/relapsed acute myeloid leukemia. And the drug is now being tested in the frontline setting in different combinations. So we are presenting from the KOMET-007 study which is looking at adding ziftomenib to aza-ven in the frontline setting as well as adding ziftomenib to 7+3. What we presented in EHA this year actually was the cohort with 7+3, where we showed that the addition was safe and resulted in a significantly high complete response rate with a high rate of MRD negativity without worsening the cytopenias. And what is being presented in ASH 2025 is the aza-ven frontline cohort as well as the aza-ven relapsed/refractory cohort. So the data is looking quite good.
We are presenting data on 40 patients where we are showing that the CR rate is actually quite high. It’s around 70%. The CRh rate is around 80%. Safety-wise, again, the combination is well-tolerated. And we are very excited about this data. So now the combination is actually going to a randomized phase 3 trial called the KOMET-017, which is two trials in one. One is 7+3 with ziftomenib versus 7 plus 3, and one is aza-ven-ziftomenib versus aza-ven. So these are essentially two big randomized phase three trials that are running in the same protocol. And we actually just enrolled the first patients on this trial in the U.S. at my center at Yale. So we are very excited about the potential to change the frontline treatment of patients with acute myeloid leukemia with NPM1 and KMT2A-mutated disease.
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