Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2–negative advanced breast cancer: final overall survival results from SOLAR-1

•In SOLAR-1, the key secondary endpoint of OS was evaluated in patients with HR+, HER2−, PIK3CA-mutated ABC.•Adding alpelisib to fulvestrant numerically improved mOS by 7.9 months, though the result was not statistically significant.•OS was numerically improved in hard-to-treat disease, including a 14-month median improvement in those with lung/liver metastases.•Median time to first chemotherapy was delayed by 8.5 months with the addition of alpelisib to fulvestrant.•With longer follow-up the alpelisib plus fulvestrant safety profile was similar to prior reports with no new safety signals. BackgroundActivation of the phosphatidylinositol-3-kinase (PI3K) pathway via PIK3CA mutations occurs in 28%-46% of hormone…

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  Novartis Pharmaceuticals Corporation