Novartis has announced today that its investigational BYL719 (alpelisib) therapy has reached its primary endpoints in the Phase III Solar-1 clinical trial. BYL719 is an alpha-specific PI3K inhibitor developed for the treatment of PIK3CA-mutant breast cancer, tested as intravenous infusion in combination with AstraZeneca’s Faslodex in 572 postmenopausal women (vs Faslodex alone or vs placebo). The announced results clearly show that the combo therapy significantly improves the patients’ PFS, helping reduce cancer progression. The trial will now continue to assess data for secondary endpoints. Novartis already has Kisqali in its portfolio, already approved in the US for metastatic breast cancer.