Kura Oncology, Inc. announced that the first patient has been dosed in KOMET-008, the Company?s Phase 1 trial of its menin inhibitor ziftomenib, in combination with gilteritinib, FLAG-IDA or LDAC for the treatment of NPM1-mutant or KMT2A-rearranged acute myeloid leukemia (AML). KOMET-008 is a Phase 1 study designed to assess safety and tolerability, pharmacokinetics and evidence of clinical activity of ziftomenib in combination with gilteritinib, FLAG-IDA or LDAC for two genetically defined cohorts, NPM1-mutant AML and KMT2A-rearranged AML, in the relapsed/refractory setting. Trial participants will be enrolled in one of five dose escalation cohorts, including a cohort of NPM1-mutant AML patients with a documented FLT3 co-mutation, who will be treated in combination with the FLT3 inhibitor gilteritinib.

Kura is conducting a series of studies to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations. In July, the Company began dosing patients in the first of these studies, KOMET-007, in combination with venetoclax and azacitidine in patients with relapsed/refractory NPM1-mutant and KMT2A-rearranged AML or in combination with standard induction cytarabine/daunorubicin chemotherapy (7+3) in patients with previously untreated NPM1-mutant and KMT2A-rearranged AML. Kura reported positive preliminary data from 20 patients in KOMET-007 on January 30, 2024.

Preclinical data for menin inhibitors in combination with multiple FLT3 inhibitors demonstrate strong synergistic effects compared to either single agent alone. Currently there are no other actively recruiting clinical trials evaluating the combination of a menin inhibitor with a FLT3 inhibitor for the treatment of AML.