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Kura Oncology and Kyowa Kirin Launch Clinical Trial Evaluating Dual Inhibition of NPM1 and FLT3 Mutations in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)
– Expanding clinical experience and safety profile of ziftomenib support its evaluation in combination with approved FLT3 inhibitors in frontline AML – – FLT3 mutations occur in approximately 30% of newly diagnosed adult patients with AML and up to 50% of adult patients with NPM1-m AML, making FLT3 one of the most common genetic alterations in AML – – Ziftomenib clinical trials are now active in multiple frontline settings that include up to 50% of incident patients with AML in the U.S. – SAN DI
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":"– Expanding clinical experience and safety profile of ziftomenib support its evaluation in combination with approved FLT3 inhibitors in frontline AML –","length":156,"tagName":"p"},{"type":"text","content":"– FLT3 mutations occur in approximately 30% of newly diagnosed adult patients with AML and up to 50% of adult patients with NPM1-m AML, making FLT3 one of the most common genetic alterations in AML – ","length":199,"tagName":"p"},{"type":"text","content":"– Ziftomenib clinical trials are now active in multiple frontline settings that include up to 50% of incident patients with AML in the U.S. –","length":141,"tagName":"p"},{"type":"text","content":"SAN DIEGO and TOKYO, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced dosing of the first patient in a cohort of the KOMET-007 clinical trial (NCT05735184). This cohort evaluates ziftomenib, a once-daily, investigational oral menin inhibitor, combined with cytarabine and daunorubicin (7+3) as well as quizartinib, for patients with newly diagnosed acute myeloid leukemia (AML). Despite recent advances, including regulatory approvals of FLT3 inhibitors such as quizartinib, patients with FLT3/NPM1 co-mutations face a high risk of relapse and limited durable treatment options. Ziftomenib is the only menin inhibitor to have received Breakthrough Therapy Designation by the Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory NPM1-mutated AML.","length":880,"tagName":"p"},{"type":"text","content":"“Patients with FLT3/NPM1 co-mutated AML, a significant subset of newly diagnosed cases, face high relapse rates and limited durable treatment options,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “Preclinical data demons...