North America
Kura Oncology and Kyowa Kirin Announce Positive Ziftomenib Monotherapy Registrational Trial and Positive FDA Feedback for Upcoming Frontline Combination Trial Designs
– KOMET-001 registrational trial in R/R NPM1-m AML achieved primary CR/CRh endpoint; topline data submitted for presentation at an upcoming medical meeting –
– NDA submission for ziftomenib on track for 2Q 2025 –
– Registrational KOMET-017-IC trial of intensive chemotherapy combination will assess MRD negative CR and EFS as dual-primary endpoints to support potential U.S. accelerated approval and full approval –
– Registrational KOMET-017-NIC trial of venetoclax / azacitidine combination will assess CR and OS as dual-primary endpoints to support potential U.S. accelerated approval and full approval –
– KOMET-017-IC and NIC Phase 3 trials expected to initiate in 2H 2025 –
– Multiple clinical data presentations for ziftomenib and pipe
05 February 2025
