Kura Oncology Announces Positive Pivotal Trial Results for Ziftomenib in Relapsed/Refractory NPM1-Mutated AML; FDA Priority Review Underway
Reuters
Sep 26
<a href="https://laohu8.com/S/KURA">Kura Oncology</a> Announces Positive Pivotal Trial Results for Ziftomenib in Relapsed/Refractory NPM1-Mutated AML; FDA Priority Review Underway
Kura Oncology Inc. and Kyowa Kirin Co., Ltd. have announced the publication of pivotal clinical trial results for ziftomenib, an investigational oral menin inhibitor, in the Journal of Clinical Oncology. The data are from the KOMET-001 trial, which evaluated ziftomenib as monotherapy in adult patients with relapsed or refractory NPM1-mutated acute myeloid leukemia (AML). The study met its primary endpoint, demonstrating significant clinical benefit and deep responses across various patient subgroups. The safety profile was favorable, with low rates of myelosuppression and no clinically significant QTc prolongation or drug-drug interactions observed. Ziftomenib is currently under FDA Priority Review for the treatment of adults with relapsed or refractory NPM1-mutated AML, with a Prescription Drug User Fee Act (PDUFA) target action date set for November 30, 2025. The results have already been published and are available on the Journal of Clinical Oncology website.
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