On September 29, 2025 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported 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) (Press release, Kura Oncology, SEP 29, 2025, View Source [SID1234656319]).

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"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 monotherapy and in combination with multiple standards of care. These two randomized Phase 3 trials offer the potential to confirm benefit across frontline populations that account for nearly half of newly diagnosed AML patients and where safe, tolerable and effective options are urgently needed."

"This is a pivotal moment for Kura, Kyowa Kirin, and patients with AML," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "To our knowledge, KOMET-017 is the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings, underscoring the potential to address a broad spectrum of patients with AML. The opportunity to advance to the frontline AML setting offers the potential to reach patients earlier in their disease course, when the possibility to meaningfully change the trajectory of the disease is greatest. The willingness of the FDA to allow the trials to use MRD negative CR and CR as primary endpoints for accelerated approval is groundbreaking and could potentially enable us to deliver ziftomenib more quickly to patients in need. We are committed to driving the KOMET-017 program forward with the goal of transforming care for patients who continue to face a devastating prognosis."

"The initiation of the KOMET-017 trial represents a significant step forward in expanding treatment options for newly diagnosed AML patients with NPM1-m and KMT2A-r," said Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin. "AML remains a disease with poor prognosis, and developing safe and effective therapies is an urgent need. Ziftomenib’s innovative mechanism of action, combined with its potential efficacy alongside both intensive and non-intensive therapies, holds promise to improve patients’ quality of life and extend survival. Kyowa Kirin is committed to collaborating closely with Kura Oncology to bring life-changing value to patients living with AML."

Each frontline trial design includes dual-primary endpoints to support potential U.S. accelerated approval and full approval. The intensive chemotherapy Phase 3 trial of ziftomenib in combination with standard induction cytarabine / daunorubicin (7+3) will assess minimal residual disease (MRD) negative complete response (CR) and event-free survival (EFS) as dual-primary endpoints. The non-intensive chemotherapy Phase 3 trial of ziftomenib in combination with venetoclax / azacitidine will assess CR and overall survival (OS) as dual-primary endpoints. The trial is intended to serve as a registrational study and builds on encouraging clinical data previously reported with ziftomenib in genetically defined subsets of AML. The trial is expected to enroll patients at up to 200 sites worldwide, reflecting strong global interest in advancing ziftomenib for patients in need. More information regarding the KOMET-017 trial is available at www.clinicaltrials.gov (identifier: NCT07007312).