Kura Oncology and Kyowa Kirin Announce Publication in Blood of Ziftomenib plus Venetoclax / Azacitidine Combination in Patients with R/R NPM1-m AML

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– 87% ORR and 70% CRc in venetoclax-naïve and 48% ORR and 24% CRc in venetoclax-experienced patients at the recommended 600 mg once-daily dose – – Central MRD negativity in 75% of CRc responders with no prior venetoclax exposure; median CRc duration was 9.2 months – – Median OS not reached after median follow up of 10.7 months in patients with no prior venetoclax exposure – – Combination was well tolerated, with low rates of differentiation syndrome and QTc prolongation observed – SAN DIEGO and TOKYO, June 02, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced the publication in Blood of updated results from the relapsed/refractory (R/R) NPM1-mutated acute myeloid leukemia (NPM1-m AML) cohort of KOMET-007, a Phase 1a/b trial evaluating ziftomenib in combination with venetoclax and azacitidine (ven/aza). The publication reports nearly two-thirds of patients experienced clinically meaningful, deep and durable responses with a well-tolerated safety profile in adults with R/R NPM1-m AML. KOMZIFTI™ (ziftomenib) is approved by the U.S. Food and Drug Administration as monotherapy for adult patients with relapsed or refractory AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Ziftomenib in combination with ven/aza is investigational and has not been approved by the FDA. “This analysis provides a more mature evaluation of ziftomenib in combination with venetoclax and azacitidine in patients with NPM1-mutated AML,” said Eunice S. Wang, M.D., Chief of Leukemia, Roswell Park Comprehensive Cancer Center, and co-first senior author of the publication. “In the relapsed/refractory setting, outcomes with venetoclax-based regimens in patients with NPM1-mutant AML remain suboptimal, highlighting the substantial need for more effective therapies. These KOMET-007 results are notable for the depth and durability of response observed with the investigational three-drug combination. The favorable safety profile also supports the continued evaluation of this combination in a setting where better treatment options are urgently needed.” “As combination approaches become increasingly important in this setting, the data highlighted in this publication strengthen the case for ziftomenib as a backbone in NPM1-mutant AML,” said Mollie Leoni, M.D., Chief Medica...

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