NEW YORK – Kura Oncology on Thursday said the first advanced acute myeloid leukemia patient has received its selective menin inhibitor KO-539 in the Phase Ib portion of the KOMET-001 trial.
The Phase I/II KOMET-001 study is exploring the safety, tolerability, and efficacy of KO-539 in refractory or relapsed AML. Kura is currently enrolling around a dozen AML patients with NPM1 mutations or KMT2A rearrangements into two Phase Ib cohorts to determine the Phase II dose of the drug. In the Phase Ib portion, researchers also have the flexibility to enroll an additional 18 patients into each cohort.
Once the optimal dose is established, Kura will begin the registration-enabling Phase II expansion portion. In a statement, Kura's chief medical officer, Stephen Dale, said the company will explore the activity of KO-539 as a single agent and in front-line combination therapy trials. "These Phase Ib expansion cohorts enable us to gather a more robust dataset in our targeted populations and help refine selection of a recommended dose for Phase II and beyond, while maintaining an aggressive development timeline for the program," Dale said.