VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor–Positive/HER2−/PIK3CA Wild-Type Advanced Breast Cancer

The Journal of Clinical Oncology has published full results from the phase 3 VIKTORIA-1 trial evaluating gedatolisib, a pan-class I PI3K/mTOR dual inhibitor, combined with fulvestrant with or without palbociclib in patients with hormone receptor-positive, HER2-negative advanced breast cancer harboring wild-type PIK3CA. This trial addresses a critical unmet need, as current PI3K-targeted agents such as alpelisib are approved only for PIK3CA-mutant disease, leaving approximately 60 percent of HR-positive advanced breast cancer patients without PI3K pathway-directed treatment options. The publication in a top-tier oncology journal signals clinically meaningful efficacy data that could reshape the treatment landscape for this large and underserved patient population. If confirmed in regulatory review, gedatolisib could become the first PI3K pathway inhibitor available regardless of PIK3CA mutation status in advanced HR-positive breast cancer.