Kura Oncology, Kyowa Kirin report data on KOMET-007 at ASH meeting

Kura Oncology (KURA) and Kyowa Kirin provided encouraging clinical data from KOMET-007, a Phase 1 dose-escalation trial of ziftomenib, a highly selective oral investigational menin inhibitor, in combination with standards of care, including cytarabine/daunorubicin and venetoclax/azacitidine, in patients with NPM1-mutant and KMT2A-rearranged acute myeloid leukemia.Ziftomenib was generally well tolerated in combination at all dose levels evaluated across all cohorts in the Phase 1a dose-escalation portion of the study. No dose-limiting toxicities, evidence of ziftomenib-associated QTc prolongation, drug-drug interactions or additive myelosuppression were observed. In the 7+3 combination cohorts, on-target differentiation syndrome occurred in 2% of patients. Grade greater than or equal to3 treatment emergent adverse events occurring in greater than or equal to20% were febrile neutropenia platelet count decreased, anemia and neutropenia count decrease and white blood cell count decreased. In the ven/aza combination cohorts, on-target DS occurred in 8% of patients. Grade greater than or equal to3 treatment emergent adverse events occurring in greater than or equal to20% were platelet count decreased, anemia and febrile neutropenia. All instances of DS were manageable, and no patients discontinued participation due to DS. The Phase 1b expansion portion of KOMET-007 is now enrolling at 600 mg in all cohorts, including patients with 1L NPM1-m or KMT2A-r AML in combination with ven/aza.