North America
Kura Oncology and Kyowa Kirin Report Positive Pivotal Ziftomenib Monotherapy Data at 2025 ASCO Annual Meeting
— CR/CRh rate of 23% in pivotal Ph 2 cohort of R/R NPM1-m AML patients —
— Consistent efficacy with comparable CR/CRh rates and clinically meaningful MRD-negative responses across pre-specified subgroups, regardless of prior HSCT, prior venetoclax, or FLT3/IDH co-mutations —
— Favorable safety and tolerability profile in heavily pre-treated patients: limited myelosuppression; no clinically meaningful QTc prolongation; 3% of patients discontinued due to treatment-related adverse events —
— Potential first approval of a once-daily, oral menin inhibitor for treatment of adult patients with relapsed or refractory NPM1-mutated AML with Priority Review and a PDUFA target action date of November 30, 2025 —
— Kura Oncology to host virtual investor event today at 7:30pm ET / 4:30pm PT —
SAN DI
02 June 2025
