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Kura Oncology and Kyowa Kirin Announce First Patient Dosed in Pivotal Phase 3 KOMET-017 Trial of Ziftomenib for Frontline Acute Myeloid Leukemia (AML)
– KOMET-017-IC trial of intensive chemotherapy combination will assess MRD negative CR and EFS as dual-primary endpoints to support potential U.S. accelerated and full approval – – KOMET-017-NIC trial of venetoclax / azacitidine combination will assess CR and OS as dual-primary endpoints to support potential U.S. accelerated and full approval – SAN DIEGO and TOKYO, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today ann
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-017-IC trial of intensive chemotherapy combination will assess MRD negative CR and EFS as dual-primary endpoints to support potential U.S. accelerated and full approval –","length":178,"tagName":"p"},{"type":"text","content":"– KOMET-017-NIC trial of venetoclax / azacitidine combination will assess CR and OS as dual-primary endpoints to support potential U.S. accelerated and full approval –","length":167,"tagName":"p"},{"type":"text","content":"SAN DIEGO and TOKYO, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced that the first patient has been dosed under the KOMET-017 clinical trial protocol (NCT07007312), comprising two independent, global, randomized double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib, Kura Oncology’s investigational menin inhibitor, in combination with both intensive and non-intensive combination regimens in patients with newly diagnosed NPM1-mutated (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML).","length":618,"tagName":"p"},{"type":"text","content":"“The dosing of the first patient under the KOMET-017 protocol is a major milestone in the pursuit of improved treatments for patients with newly diagnosed AML,” said Amer Zeidan, M.B.B.S., M.H.S., Chief of the Division of Hematologic Malignancies, Director of Hematology Early Therapeutics Research at Yale Cancer Center and lead investigator of KOMET-017. “AML remains one of the most aggressive and difficult-to-treat blood cancers, with many patients relapsing despite currently available therapies. Ziftomenib, which in my opinion has the potential to be the best-in-class menin inhibitor, has demonstrated promising safety and activity in early phase clinical trials of NPM1-m and KMT2A-r AML both as monot...