Kura Oncology and Kyowa Kirin Announce First Patient Dosed in Pivotal Phase 3 KOMET-017 Trial of Ziftomenib for Frontline Acute Myeloid Leukemia (AML)

Core Insights - The first patient has been dosed in the KOMET-017 clinical trial, which evaluates ziftomenib, a menin inhibitor, for treating newly diagnosed acute myeloid leukemia (AML) patients with specific genetic mutations [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline targeting hematologic malignancies and solid tumors [3] - Kyowa Kirin is a Japan-based global specialty pharmaceutical company dedicated to drug discovery and biotechnology innovation, particularly in hematological diseases and rare diseases [5] Clinical Trial Details - The KOMET-017 trial consists of two Phase 3 studies: one assessing ziftomenib with intensive chemotherapy (cytarabine/daunorubicin) and the other with non-intensive chemotherapy (venetoclax/azacitidine) [2][3] - The intensive trial will evaluate minimal residual disease (MRD) negative complete response (CR) and event-free survival (EFS) as dual-primary endpoints, while the non-intensive trial will assess CR and overall survival (OS) [2][3] Market Potential - The trials aim to confirm the efficacy of ziftomenib in nearly half of newly diagnosed AML patients, addressing a significant unmet medical need for safe and effective treatment options [2][3] - The FDA's acceptance of MRD negative CR and CR as primary endpoints for accelerated approval is seen as a groundbreaking opportunity to expedite ziftomenib's availability to patients [2]