Core Insights - Ziftomenib monotherapy demonstrated significant clinical benefit in treating relapsed/refractory NPM1-mutated acute myeloid leukemia (AML) with a complete remission rate of 22% [4][5] - The drug showed consistent activity across various patient subgroups, regardless of previous treatments or genetic mutations [4][5] - Ziftomenib has a favorable safety profile, with manageable adverse events and no significant drug-drug interactions [6][8] Company Overview - Kura Oncology is focused on developing precision medicines for cancer treatment, with ziftomenib being a key investigational drug targeting menin inhibition [10] - Kyowa Kirin is a global specialty pharmaceutical company committed to drug discovery and biotechnology innovation, collaborating with Kura Oncology on ziftomenib [11] Clinical Trial Results - The KOMET-001 trial included 92 adult patients, achieving an overall response rate of 33% and a median duration of response of 4.6 months [3][4] - Median overall survival for all patients was reported at 6.6 months, with responders showing a median survival of 18.4 months [5] - The trial's findings support the New Drug Application for ziftomenib, with a target FDA action date set for November 30, 2025 [7]
Kura Oncology and Kyowa Kirin Announce Publication of Pivotal Ziftomenib Data in Relapsed/Refractory NPM1-Mutated AML in the Journal of Clinical Oncology