The recently concluded Phase III SOLAR-1 trial for BYL719, also called alpelisib, has drawn a lot of attention in the medical world as it could represent the beginning of a new treatment option for some types of advanced breast cancer.
The investigational drug is designed to target and inhibit PIK3CA mutations and is meant to be combined with Fulvestrant (Faslodex), a drug already used for more than 15 years in treating HR+/HER2 advanced or metastatic breast cancers.
By disrupting the signaling pathway PI3K, known to be the most frequently altered gene associated with promoting tumor growth, disease progression and treatment resistance in HR+, scientists are hoping to provide an aromatase inhibitor treatment that would help cases that currently have no other option left.
“BYL719 is the only alpha-specific PI3K inhibitor and the first one to show potential increased benefit and acceptable tolerability for patients,” said in a press release Samit Hirawat, MD, Head of Novartis Oncology Global Drug Development.
The SOLAR-1 trial involved 572 patients and consisted of daily doses of 300mg of alpelisib along with intramuscular injections of 500mg fulvestrant on days 1 and 15 of the first cycle and on day 1 of the next 28-day cycle plan. While the full results have not been made public yet (but will be in an upcoming medical congress), data so far seems to point towards an important success.
The news comes only months after Swiss pharmaceutical giants, Roche, abandoned trials for a similar drug, Taselisib, following modest progression-free of survival rates and significant adverse effects for patients.