Kura to take AML drug ziftomenib to regulators after mid-stage win

6 February 2025

Kura Oncology (Nasdaq: KURA) and Japan’s Kyowa Kirin (TYO: 4151) have announced that their menin inhibitor ziftomenib met the primary endpoint in a Phase II trial for relapsed or refractory acute myeloid leukemia (AML).

The outcome sets the stage for a potential regulatory submission, with plans also for a Phase III program to evaluate the drug in newly diagnosed patients.

The KOMET-001 trial, which tested ziftomenib in patients with NPM1-mutant AML, achieved statistical significance on its primary efficacy endpoint.

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