Kura Oncology and Kyowa Kirin Announce Publication of Pivotal Ziftomenib Data in Relapsed/Refractory NPM1-Mutated AML in the Journal of Clinical Oncology

– KOMET-001 in R/R NPM1-m AML met its primary endpoint with ziftomenib monotherapy demonstrating significant clinical benefit and deep responses – – Consistent activity across pre-specified subgroups, regardless of prior HSCT, prior venetoclax, lines of therapy, or FLT3/IDH co-mutations – – Favorable safety and tolerability profile, including a lack of clinically significant QTc prolongation or myelosuppression – – Prescription Drug User Fee Act (PDUFA) target action date for FDA Priority Review of ziftomen ...