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)

On October 1, 2025 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported dosing of the first patient in a cohort of the KOMET-007 clinical trial (NCT05735184) (Press release, Kura Oncology, OCT 1, 2025, View Source [SID1234656381]). 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.

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"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 demonstrate that ziftomenib synergizes with FLT3 inhibitors such as quizartinib, potentially enhancing activity without increasing toxicity. The KOMET-007 trial, alongside our recently launched KOMET-017 registrational trial combining ziftomenib with intensive and non-intensive chemotherapy, reflects our commitment to integrating menin inhibition across AML treatment regimens to improve patient outcomes."

"Initiation of the FLT3 inhibitor cohort in the KOMET-007 trial marks a pivotal advancement in addressing the urgent needs of patients with FLT3/NPM1 co-mutated AML," said Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin. "FLT3 mutations play a critical role in AML, driving aggressive leukemia cell proliferation, leading to poor prognosis, higher relapse rates, and shorter overall survival. Kyowa Kirin is proud to collaborate with Kura Oncology to advance this innovative menin inhibitor combination, aiming to improve outcomes for AML patients throughout the continuum of care."

The trial arm will evaluate safety, tolerability and activity of intensive chemotherapy and quizartinib in combination with ziftomenib in adult patients with newly diagnosed FLT3-ITD / NPM1 co-mutated AML. Primary and secondary endpoints include complete remission (CR) and composite complete remission (CRc). More information regarding this trial arm and the KOMET-007 trial is available at www.clinicaltrials.gov (identifier: NCT05735184).

Ziftomenib is currently under clinical development, and its safety and efficacy have not been established by any regulatory authority.