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Kura Oncology Announces First Patients Dosed in Phase 2 Registration-Directed Trial of Ziftomenib in NPM1-Mutant Acute Myeloid Leukemia
– Phase 1 trial showed 30% CR rate among 20 NPM1-mutant AML patients treated at recommended Phase 2 dose – – Phase 2 registration-directed trial expected to
About this update from Kura Oncology, Inc.
[{"type":"text","content":"– Phase 1 trial showed 30% CR rate among 20 NPM1-mutant AML patients treated at recommended Phase 2 dose – – Phase 2 registration-directed trial expected to enroll 85 patients in the U.S. and Europe – SAN DIEGO, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that the first patients have been dosed in its KOMET-001 Phase 2 registration-directed trial of ziftomenib, the Company’s novel menin inhibitor, in patients with NPM1-mutant relapsed or refractory acute myeloid leukemia (AML). “Dosing the first patients in our registration-directed trial of ziftomenib marks a significant milestone for our menin inhibitor program,” said Troy Wilson, Ph.D., J.D., President & Chief Executive Officer of Kura Oncology. “Building on the strength of our Phase 1 data, we remain committed to our mission to realize the full potential of ziftomenib as an important treatment option to patients with acute leukemia. The speed with which we have begun enrolling in this registration-enabling Phase 2 study speaks to the significant interest in ziftomenib among investigators.” In the Phase 1 clinical trial, ziftomenib showed as of the data cutoff on October 24, 2022, a 30% complete response (CR) rate among 20 NPM1-mutant AML patients treated at 600 mg. In addition, the favorable safety profile and encouraging tolerability at the 600 mg daily dose resulted in its designation as the recommended Phase 2 dose following a positive Type C meeting with the U.S. Food and Drug Administration (FDA). The primary endpoint in the Phase 2 registration-directed trial in patients with NPM1-mutant relapsed or refractory AML, is CR or complete response with hematologic recovery (CRh), and key secondary endpoints include clinical benefit as well as safety and tolerability. In addition to continued evaluation of ziftomenib as a monotherapy in NPM1-mutant AML, Kura plans to initiate the KOMET-007 and KOMET-008 trials later this year to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML. For more information regarding the KOMET-001 trial, please visit www.clinicaltrials.gov (identifier:...