Novartis (NVS) announced additional analysis from the global Phase III SOLAR-1 trial investigating the alpha-specific PI3K inhibitor BYL719 in combination with fulvestrant in men and postmenopausal women with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer. In SOLAR-1, the addition of BYL719 to fulvestrant nearly doubled median progression-free survival in patients with PIK3CA mutated HR+/HER2- advanced breast cancer who progressed on or after an aromatase inhibitor compared to fulvestrant alone. In this analysis, BYL719 plus fulvestrant also showed consistent clinically meaningful treatment benefit after progression on an AI or after receiving up to one additional line of therapy for advanced breast cancer. These data will be presented today during an oral presentation at the 2018 San Antonio Breast Cancer Symposium. BYL719 in combination with fulvestrant consistently improved median PFS in patients with PIK3CA mutated HR+/HER2- advanced breast cancer who progressed within 12 months of AI treatment or received up to one additional line of therapy for advanced breast cancer. Mutation status of participants in SOLAR-1 was identified by a clinical trial assay developed by Qiagen (QGEN). A significant PFS benefit was observed for BYL719 plus fulvestrant in patients with a PIK3CA mutation regardless of whether the mutation was identified by a tumor tissue test or ctDNA test, suggesting the potential viability of using liquid biopsies to identify PIK3CA mutation status. Novartis has entered into agreements with both Qiagen and Foundation Medicine to develop flexible companion diagnostic solutions for BYL719 that utilize both tumor tissue and plasma sample types.
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