Novartis has secured approval from the US Food and Drug Administration (FDA) for its breast cancer drug combo Piqray (alpelisib, formerly BYL719) plus fulvestrant.
The FDA has approved Piqray kinase inhibitor in combination with fulvestrant to treat postmenopausal women, and men with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after endocrine-based regimen.
The approval was based on data from the phase III Solar-1 study, which demonstrated Piqray plus fulvestrant nearly doubled median progression-free survival (PFS) compared against fulvestrant alone in HR+/HER2- advanced breast cancer patients with a PIK3CA mutation.
According to the company, Piqray offered consistent PFS results across pre-specified subgroups including among patients previously treated with a CDK4/6 inhibitor and overall response rate (ORR) was more than doubled when Piqray was added to fulvestrant in patients with a PIK3CA mutation.
Solar-1 is a global, phase 111 randomized, double-blind and placebo-controlled study designed to assess 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.
The company has randomized 572 patients in the trial, and patients have been allocated based on central tumor tissue assessment to either a PIK3CA-mutated cohort or a PIK3CA non-mutated cohort.
The trial’s primary endpoint is local investigator evaluated PFS using RECIST 1.1 for patients with a PIK3CA mutation, while major secondary endpoint is overall survival and additional secondary endpoints are overall response rate, clinical benefit rate, health-related quality of life, efficacy in PIK3CA non-mutated cohort, safety and tolerability.
Novartis Oncology CEO Dr Susanne Schaffert said: “The FDA approval of Piqray, which was discovered at the Novartis Institutes for BioMedical Research, marks the first ever treatment specifically for HR+/HER2- advanced breast cancer with a PIK3CA mutation.
“We are grateful to our researchers’ bold and unrelenting pursuit of a first-in-class treatment for this incurable disease, and to the patients, investigators and administrators who participated in the clinical trials leading to this remarkable milestone.”