Business
Kura Oncology and Kyowa Kirin Report Positive Pivotal Ziftomenib Monotherapy Data at 2025 ASCO Annual Meeting
– CR/CRh rate of 23% in pivotal Ph 2 cohort of R/R NPM1-m AML patients – – Consistent efficacy with comparable CR/CRh rates and clinically meaningful
About this update from Kura Oncology, Inc.
[{"type":"text","content":"– CR/CRh rate of 23% in pivotal Ph 2 cohort of R/R NPM1-m AML patients – – Consistent efficacy with comparable CR/CRh rates and clinically meaningful MRD-negative responses across pre-specified subgroups, regardless of prior HSCT, prior venetoclax, or FLT3/IDH co-mutations – – Favorable safety and tolerability profile in heavily pre-treated patients: limited myelosuppression; no clinically meaningful QTc prolongation; 3% of patients discontinued due to treatment-related adverse events – – Potential first approval of a once-daily, oral menin inhibitor for treatment of adult patients with relapsed or refractory NPM1-mutated AML with Priority Review and a PDUFA target action date of November 30, 2025 – – Kura Oncology to host virtual investor event today at 7:30pm ET / 4:30pm PT – SAN DIEGO and TOKYO, June 02, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) announced the presentation of positive pivotal results from the KOMET-001 Phase 2 registration-directed trial of ziftomenib, a once-daily, oral investigational menin inhibitor, in patients with relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML) in an oral session today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, IL from May 30 - June 3, 2025. \"We are delighted to announce positive pivotal data from the KOMET-001 trial in R/R NPM1-mutated AML patients treated with ziftomenib,\" said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. \"NPM1 mutations are among the most common in AML, representing approximately 30% of cases, and there are no FDA-approved therapies specifically for this patient population. With these encouraging results and a PDUFA target action date of November 30, 2025, we and our partners at Kyowa Kirin look forward to supporting FDA with its review of the ziftomenib New Drug Application (NDA) and are well-positioned to meaningfully impact relapsed or refractory patients with NPM1 mutations.” \"Relapsed or refractory NPM1-mutated AML is a highly challenging disease with a poor prognosis and an urgent need for new treatments,\" said Eunice Wang, M.D., Chief of Leukemia Service, Professor of Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, NY. \"The promising results for zift...