Novartis’ BYL719 Improved Patient Survival in Phase 3 Trial of Advanced Breast Cancer

Novartis’ BYL719 Improved Patient Survival in Phase 3 Trial of Advanced Breast Cancer
Treatment with Novartis’s BYL719 (alpelisib) was seen to improve progression-free survival (PFS) in the Phase 3 SOLAR-1 clinical trial in patients with HR-positive, HER2-negative advanced breast cancer who received prior treatment with an aromatase inhibitor. BYL719 is an investigational PI3K inhibitor in development for the treatment of patients with PIK3CA gene mutations. Approximately 40% of hormone-receptor positive advanced breast cancer patients have mutations in the PIK3CA gene, which provides instructions to make a protein that is involved in the PI3K cell signaling pathway. Several studies have indicated that PI3K signaling plays a role in several processes that are critical for cancer progression. In fact, activation of the PI3K pathway in breast cancer is associated with a worse prognosis. Preclinical studies have shown that the use of BYL719 blocks the PI3K pathway. SOLAR-1 (NCT02437318) is a global, randomized, double-blind, placebo-controlled trial that was designed to evaluate the use of BYL719 in combination with fulvestrant (brand name Faslodex), compared to fulvestrant alone, in patients with HR-positive/HER2-negative PIK3CA-mutated advanced or metastatic breast cancer, who have progressed on or after treatment with an aromatase inhibitor (a class of drugs commonly used in the treatment of breast cancer). Patients enrolled in the study were randomized in a 1:1 ratio to receive either 300 mg of BYL719 or a placebo, once daily, in combination with 500 mg of fulvestrant intramuscul
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