Genentech announces INAVO120 study met key secondary endpoint

Genentech, a member of Roche (RHHBY), announced topline results from the overall survival analysis of the Phase III INAVO120 study investigating Itovebi in combination with palbociclib and fulvestrant for people with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The study met its key secondary endpoint, showing a statistically significant and clinically meaningful OS benefit with the Itovebi-based regimen compared with palbociclib and fulvestrant alone. These OS results build upon the previously reported primary analysis, which showed that the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the first-line setting. OS data were immature at the time of primary analysis, but a clear positive trend was observed at that time. No new safety signals were observed since the previous analysis. The full results from the OS analysis will be presented at an upcoming medical meeting.