alpelisib + pembrolizumab

A combination therapy consisting of alpelisib, a phosphatidylinositol 3-kinase (PI3K) inhibitor that specifically targets the alpha isoform of PI3K, and pembrolizumab, an established immune checkpoint inhibitor that targets PD-1, enhancing the body's immune response against cancer cells. This investigational regimen targets both the PI3K pathway (commonly altered in various cancers, particularly those with PIK3CA mutations) and enhances T-cell mediated immune response against cancer cells. Alpelisib is already FDA-approved in combination with fulvestrant for treating hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer. Pembrolizumab is an established immune checkpoint inhibitor.