Kura Oncology reports preliminary ziftomenib combination data

Kura Oncology reported preliminary clinical data from the first 20 patients in KOMET-007, a Phase 1 dose-escalation trial of the Company’s potent and selective menin inhibitor, ziftomenib, in combination with standards of care, including cytarabine/daunorubicin and venetoclax/azacitidina, in patients with NPM1-mutant and KMT2A-rearranged acute myeloid leukemia, AML. Continuous daily dosing of ziftomenib at 200 mg QD has been well tolerated and the safety profile consistent with features of underlying disease and backbone therapies. No differentiation syndrome events of any grade were reported, and no dose-limiting toxicities, evidence of QTc prolongation, drug-drug interactions or additive myelosuppression were observed. As of the data cutoff on January 11, 2024, all newly diagnosed patients treated with ziftomenib and 7+3 achieved a complete remission with full count recovery, for a CR rate of 100%, including four patients with NPM1-m AML and one patient with KMT2A-r AML. The overall response rate among R/R patients treated with ziftomenib and ven/aza was 53%. Among all patients treated with ziftomenib and ven/aza, 40% received prior treatment with a menin inhibitor. The CR/CRh2 rate in patients who were menin inhibitor naive was 56% including 60% in patients with NPM1-m AML and 50% in patients with KMT2A-r AML. The ORR in patients who received prior venetoclax was 40%, including 60% in patients with NPM1-m AML. As of the data cutoff, 80% of patients remain on trial, including 100% of all NPM1-m patients