Phase III SOLAR-1 trial of Piqray shows efficacy in advanced PIK3CA breast cancer.- Novartis

Novartis announced results of the final overall survival (OS) analysis from the phase III 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. 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?0.0161 ; HR=0.86; 95% CI: 0.64-1.15; p=0.15). This difference did not reach the prespecified threshold of statistical significance set for the secondary objective of OS in patients with PIK3CA-mutated breast cancer. A more than 14 month OS improvement was observed in patients with lung or liver metastases, which signify more aggressive disease (median OS 37.2 months vs. 22.8 months; HR=0.68; 95% CI: 0.46-1.00). Patients whose tumors have a PIK3CA mutation, particularly those with lung or liver metastases, have a more aggressive, harder to treat cancer, so these results showing alpelisib offers longer life, are promising.In addition, data showed the need for chemotherapy was delayed in patients taking Piqray plus fulvestrant by nine months compared to those taking fulvestrant alone (23.3 months vs. 14.8 months; HR=0.72; 95% CI: 0.54-0.95). Quality of life (QOL) was maintained for people taking Piqray plus fulvestrant. No new safety signals were observed; adverse events were consistent with previously reported SOLAR-1 results. These data will be presented as a late-breaking oral presentation during the ESMO Virtual Congress 2020. 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. SOLAR-1 is a global, Phase III, randomized, double-blind, placebo-controlled trial studying Piqray in combination with fulvestrant for postmenopausal women, and men, with PIK3CA-mutated HR+/HER2- advanced or metastatic breast cancer that progressed on or following aromatase inhibitor treatment with or without a CDK4/6 inhibitor.