July 31 Clinical Quick Takes: Novartis' Kisqali shows OS benefit; plus Atlantic and Translate Bio
Kisqali improves survival for postmenopausal breast cancer
Novartis AG (NYSE:NVS; SIX:NOVN) reported interim data showing CDK4/CDK6 inhibitor Kisqali ribociclib plus fulvestrant met the secondary endpoint of significantly improved overall survival in the Phase III MONALEESA-3 study for HR+/HER2- advanced postmenopausal breast cancer (see "FDA Real-time Pilot Speeds Kisqali Label Expansion").
Atlantic therapy misses Phase III pouchitis endpoints
Atlantic Healthcare plc (Saffron Walden, U.K.) announced Phase III results showing alicaforsen enema missed the co-primary endpoints of endoscopic remission and bowel frequency for pouchitis. The company said the therapy led to a statistically significant endoscopic response in several patient subgroups. Atlantic is planning to meet with FDA to discuss next steps...