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Kura Oncology Begins Testing Menin Inhibitor With Standard Therapies in Phase I AML Trial

NEW YORK – Kura Oncology said Monday that it has treated the first acute myeloid leukemia patient with the investigational menin inhibitor ziftomenib plus standard-of-care treatments in the Phase I KOMET-008 trial.

In the trial, San Diego-based Kura is evaluating the safety and preliminary efficacy of ziftomenib with either Astellas Oncology's FLT3 inhibitor Xospata (gilteritinib) or a standard chemotherapy regimen in relapsed or refractory AML patients harboring either NPM1 mutations or KMT2A rearrangements.

The company hopes to enroll 171 patients in the trial and assign them to one of five cohorts based on their biomarker status. In each cohort, patients will receive ziftomenib, but the accompanying standard-of-care regimen will differ. Only patients who have FLT3 mutations will receive the combination of ziftomenib plus Xospata.

According to Kura, preclinical data suggests menin inhibitors plus FLT3 inhibitors may have synergistic effects, and roughly half of relapsed or refractory NPM1-mutant AML patients also have FLT3 mutations. The KOMET-008 trial is the first to combine the two types of drugs for treating AML, according to the company.

The start of KOMET-008 comes a month after Kura shared encouraging preliminary data from the Phase I KOMET-007 trial. In that study, Kura is studying ziftomenib plus a regimen containing AbbVie's BCL-2 inhibitor Venclexta (venetoclax) and chemotherapy in patients with NPM1-mutated or KMT2A-rearranged AML. In that study, as of Jan. 11, five newly diagnosed AML patients who received ziftomenib and chemo had achieved a complete remission. 

The news also comes a month after Kura announced a $150 million private placement, which it said it would put toward advancing ziftomenib trials.