- Additional data from a Phase 3 clinical trial, SOLAR-1, evaluating Novartis' (NYSE:NVS -3%) PI3K inhibitor BYL719 (alpelisib), combined with AstraZeneca's (AZN -3.2%) FASLODEX (fulvestrant), in men and postmenopausal women with PIK3CA mutation-positive HR+/HER2- advanced/metastatic breast cancer showed a positive effect on progression-free survival (PFS). The results were presented at the San Antonio Breast Cancer Symposium.
- Patients who progressed within 12 months after receiving an aromatase inhibitor (e.g., Ani Pharma's Arimidex) who received the combination experienced median PFS of 11.0 months compared to 6.8 months for fulvestrant alone. Median PFS as also superior for the combo in patients who received an additional line of therapy, 10.9 months versus 3.7 months, respectively.
- The company has started discussing the data with health authorities.
- Previously: Novartis' BYL719 shows positive effect in late-stage study (Oct. 22)