On September 29, 2025, Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. announced that the first patient has been dosed under the KOMET‑017 clinical trial protocol (NCT07007312). The trial consists of two independent, global, randomized, double‑blind, placebo‑controlled Phase 3 studies evaluating ziftomenib in combination with intensive chemotherapy (7+3) and non‑intensive therapy (venetoclax/azacitidine) in newly diagnosed patients with NPM1‑mutated or KMT2A‑rearranged acute myeloid leukemia.
This milestone marks the transition of ziftomenib from early‑stage studies into the pivotal Phase 3 stage, a prerequisite for regulatory approval. The intensive arm will assess minimal residual disease‑negative complete response and event‑free survival as dual primary endpoints, while the non‑intensive arm will evaluate complete response and overall survival. Successful outcomes could support accelerated and full FDA approval, potentially bringing a new oral menin inhibitor to frontline AML patients.
The announcement underscores the strategic partnership between Kura and Kyowa Kirin, which provides shared development and commercialization resources. By initiating the Phase 3 program, Kura positions ziftomenib to address a substantial unmet need in approximately half of newly diagnosed AML patients, potentially expanding its market reach beyond the relapsed/refractory setting. The first‑patient dose also signals progress toward the company’s broader goal of establishing ziftomenib as a best‑in‑class therapy for genetically defined leukemias.
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