Piqray + fulvestrant receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation.- Novartis

Novartis has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy. The CHMP opinion is based on results of the Phase III SOLAR-1 trial that showed Piqray plus fulvestrant nearly doubled median progression-free survival (PFS) compared to fulvestrant alone in HR+/HER2- advanced breast cancer patients with tumors harboring a PIK3CA mutation (median PFS 11.0 months vs. 5.7 months; HR=0.65, 95% CI: 0.50-0.85; p<0.001), the studys primary endpoint. pfs subgroup analyses demonstrated consistent efficacy in favor of piqray irrespective of presence or absence of lung liver metastases. in solar-1 most adverse events were mild to moderate in severity and generally manageable through dose modifications and medical management. of these the most common grade 3 4 events greater than 7 were plasma glucose increased 39.1 rash 19.4 gamma-glutamyltransferase increased 12.0 lymphocyte count decreased 9.2 diarrhea 7.0 and lipase increased 7.0. no patients developed diabetes as a result of transient hyperglycemia.. pik3ca is the most commonly mutated gene in hr her2- advanced breast cancer affecting approximately 40 of patients. if approved alpelisib has the potential to transform the way we treat this cancer in europe offering physicians a clear treatment for patients with a pik3ca mutation that nearly doubles the time to disease progression said fabrice andr md phd research director and head of inserm unit u981 professor in the department of medical oncology at institut gustave roussy in villejuif france and global solar-1 principal investigator..>