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Kura Oncology and Kyowa Kirin Announce Publication of Pivotal Ziftomenib Data in Relapsed/Refractory NPM1-Mutated AML in the Journal of Clinical Oncology
– KOMET-001 in R/R NPM1-m AML met its primary endpoint with ziftomenib monotherapy demonstrating significant clinical benefit and deep responses – – Consistent activity across pre-specified subgroups, regardless of prior HSCT, prior venetoclax, lines of therapy, or FLT3/IDH co-mutations – – Favorable safety and tolerability profile, including a lack of clinically significant QTc prolongation or myelosuppression – – Prescription Drug User Fee Act (PDUFA) target action date for FDA Priority Review
About this update from Kyowa Kirin Co., Ltd.
[{"type":"image","alt":"Kura Oncology, Inc.","displaySize":"","headline":null,"caption":"Kura Oncology, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":72,"url":"https://media.zenfs.com/en/globenewswire.com/d6453a374a5f05394e6f1d6f812c8372"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/wG0uDTBPyRmW8vIONtudPw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEwMTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/d6453a374a5f05394e6f1d6f812c8372","width":300,"height":72}},"lazy":false},{"type":"text","content":"– KOMET-001 in R/R NPM1-m AML met its primary endpoint with ziftomenib monotherapy demonstrating significant clinical benefit and deep responses –","length":146,"tagName":"p"},{"type":"text","content":"– Consistent activity across pre-specified subgroups, regardless of prior HSCT, prior venetoclax, lines of therapy, or FLT3/IDH co-mutations –","length":142,"tagName":"p"},{"type":"text","content":"– Favorable safety and tolerability profile, including a lack of clinically significant QTc prolongation or myelosuppression –","length":131,"tagName":"p"},{"type":"text","content":"– Prescription Drug User Fee Act (PDUFA) target action date for FDA Priority Review of ziftomenib in adults with R/R NPM1-m AML set for November 30, 2025 –","length":160,"tagName":"p"},{"type":"text","content":"SAN DIEGO and TOKYO, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced the Journal of Clinical Oncology published the full results from the pivotal KOMET-001 clinical trial (NCT04067336) evaluating ziftomenib, an investigational, once-daily, oral menin inhibitor, in adult patients with relapsed/refractory (R/R) NPM1-mutated (NPM1-m) acute myeloid leukemia (AML). Although newly diagnosed patients with NPM1-m AML have high response rates to approved standard of care, relapses are common and survival outcomes are poor. There is currently no approved therapy to specifically target NPM1-m AML. Ziftomenib is currently under priority review by the Food and Drug Administration (FDA) for treatment of R/R NPM1-m AML.","length":810,"tagName":"p"},{"type":"text","content":"“Relapsed or refractory NPM1-mutated AML remains very challenging to treat, particularly after venetoclax-based therapy or transplant,” said Eunice Wang, M.D., Chief of...