- In SOLAR-1 final analysis, Piqray (alpelisib) plus fulvestrant demonstrated 8 months clinically relevant improvement in overall survival (OS) in HR+/HER2- advanced breast cancer (aBC) patients with a PIK3CA mutation compared to fulvestrant alone1
- 14+ months OS improvement was achieved in patients with lung or liver metastases, which are observed in 41% of postmenopausal women with HR+ aBC, and considered more aggressive and challenging to treat1-3
- Data add to growing body of evidence for Piqray, the first and only treatment specifically approved for aBC with a PIK3CA mutation
Basel, September 19, 2020 - Novartis today announced results of the final overall survival (OS) analysis from the SOLAR-1 trial, which evaluated Piqray (alpelisib) in combination with fulvestrant, compared to fulvestrant alone, in hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer patients with tumors harboring a PIK3CA mutation. Piqray is the only treatment approved in Europe, the United States and 15 other countries specifically for people with HR+/HER2- advanced breast cancer with a PIK3CA mutation. These data will be presented as a late-breaking oral presentation during the ESMO Virtual Congress 2020.
In the study, there was a clinically relevant improvement in OS of eight months for patients with a PIK3CA mutation taking Piqray plus fulvestrant compared to fulvestrant alone (median OS 39.3 months vs. 31.4 months; one-sided p