Kura Oncology (KURA) and Kyowa Kirin said Thursday the investigational menin inhibitor ziftomenib met its primary endpoint in the phase 2 Komet-001 trial in adults with relapsed or refractory NPM1-mutated acute myeloid leukemia.

Ziftomenib monotherapy produced a 22% complete remission with full or partial hematologic recovery rate compared with the 12% historical standard, with an overall response rate of 33% and median overall survival of 6.6 months.

The treatment was generally well tolerated, with febrile neutropenia, anemia, and thrombocytopenia among the most common grade 3 or higher adverse events.

The results were published in the Journal of Clinical Oncology. The FDA is reviewing ziftomenib for this indication under priority review, with a target action date of Nov. 30.