Roche announced a positive CHMP opinion for Itovebi (inavolisib) in combination with palbociclib and fulvestrant for PIK3CA-mutated advanced breast cancer. This recommendation is based on Phase III INAVO120 data, showing significant improvement in progression-free survival. The Itovebi-based regimen demonstrated a doubling of progression-free survival compared to the control arm. A statistically significant and clinically meaningful benefit in overall survival was also observed. Final overall survival results will be presented at the 2025 ASCO Annual Meeting. The PIK3CA mutation, found in about 40% of HR-positive breast cancers, often leads to poorer outcomes. Itovebi is currently approved in several countries and is also being investigated in other Phase III studies. Itovebi is an oral, targeted treatment designed to be potent and specific for the PI3K alpha isoform. The INAVO120 study involved patients with PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer.