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ASCO 2025 | Update on the KOMET-001 trial: ziftomenib in NPM1-mutant AML
Eunice Wang, MD, Roswell Park Comprehensive Cancer Center, Buffalo, NY, presents the updated results of the pivotal Phase II KOMET-001 study (NCT04067336), which examined the efficacy of the menin inhibitor ziftomenib in patients with NPM1-mutant acute myeloid leukemia (AML). Dr Wang highlights that the trial reached its primary endpoint, and expresses hope that this agent will be considered for approval in this patient population shortly. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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Transcript
So, also at ASCO 2025, I’ll be presenting the pivotal results of the Phase II KOMET-001 study that examined the efficacy of the new menin inhibitor, ziftomenib, for patients with NPM1 mutant AML. Prior studies have demonstrated that the recommended Phase II dose for ziftomenib is 600 milligrams a day. And at this ASCO meeting, I’m presenting data demonstrating that, in this pivotal secondary study enrolling 90 patients in the Phase II and 20 patients in the Phase Ib, the overall response rate to ziftomenib monotherapy was 35%, the CR/CRh rate was 25%, and 65 percent of patients had MRD-negative disease...
So, also at ASCO 2025, I’ll be presenting the pivotal results of the Phase II KOMET-001 study that examined the efficacy of the new menin inhibitor, ziftomenib, for patients with NPM1 mutant AML. Prior studies have demonstrated that the recommended Phase II dose for ziftomenib is 600 milligrams a day. And at this ASCO meeting, I’m presenting data demonstrating that, in this pivotal secondary study enrolling 90 patients in the Phase II and 20 patients in the Phase Ib, the overall response rate to ziftomenib monotherapy was 35%, the CR/CRh rate was 25%, and 65 percent of patients had MRD-negative disease. Moreover patients who achieved responses had clinical benefit, with 20% of them achieving transfusion independence when they were transfusion-dependent at baseline.
In conclusion, we think that these Phase II results demonstrating that ziftomenib resulted in a significant enhancement in CR/CRh as opposed to a historical control met its primary endpoint for demonstrating its efficacy in this patient population, and we hope to see this drug moving towards potential approval for treatment of these patients in the near future.
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