Genentech announces final results from OS analysis of Phase III INAVO120 study

Genentech, a member of the Roche (RHHBY) Group, announced positive final results from the overall survival, OS, analysis of the Phase III INAVO120 study. These data showed Itovebi, in combination with palbociclib and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement in overall survival for people with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The results are being presented in an oral session at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting and simultaneously published in the New England Journal of Medicine, NEJM. The Itovebi-based regimen demonstrated a meaningful OS benefit compared with palbociclib and fulvestrant alone. The median OS was 34.0 months for people in the Itovebi arm, compared with 27.0 months in the palbociclib and fulvestrant arm. The benefit seen in delaying cancer progression was maintained in the updated analysis, with the Itovebi-based regimen showing a consistent improvement in median progression free survival of 17.2 months versus 7.3 months in the comparator arm.