On October 1, 2025 Kura Oncology, Inc. and Kyowa Kirin announced the dosing of the first patient in a new cohort of the KOMET‑007 clinical trial (NCT05735184). The cohort evaluates ziftomenib, a once‑daily oral menin inhibitor, combined with the standard 7+3 chemotherapy regimen and the FLT3 inhibitor quizartinib for patients with newly diagnosed acute myeloid leukemia (AML) harboring co‑mutations in NPM1 and FLT3. The announcement was made from San Diego and Tokyo.
This new combination expands ziftomenib’s clinical experience into a frontline AML setting that includes a high‑risk FLT3‑mutated population. By pairing the menin inhibitor with a FLT3 inhibitor, Kura aims to address the high relapse rates seen in FLT3/NPM1 co‑mutated AML and to demonstrate synergistic activity without increasing toxicity.
Kura’s broader strategy is to integrate menin inhibition across AML regimens, building on earlier trials such as KOMET‑001 and the ongoing KOMET‑007 study. The first‑patient dosing milestone supports the company’s plan to pursue accelerated approval pathways and to broaden the patient population eligible for ziftomenib.
For investors, the first‑patient dosing marks a critical development milestone that may accelerate regulatory review and expand market access. It also demonstrates Kura’s ability to execute complex combination trials, reinforcing its competitive position in the precision‑oncology landscape.
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