Roche Reports Positive Survival Data for Itovebi in Breast Cancer

Roche has shared promising topline results from the Phase III INAVO120 study evaluating Itovebi™ (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant for patients with PIK3CA-mutated, HR-positive, HER2-negative, endocrine-resistant advanced breast cancer. The study met its key secondary endpoint, demonstrating a statistically significant and clinically meaningful overall survival (OS) benefit compared to the current standard of palbociclib and fulvestrant alone.

Dr. Levi Garraway, Roche’s Chief Medical Officer, highlighted the potential of the Itovebi-based regimen to set a new standard of care, as it not only delayed disease progression but also extended patient survival. This builds on earlier results showing a 57% risk reduction in disease progression or death (15.0 months vs. 7.3 months). With Itovebi already FDA-approved for this indication and under review by global health authorities, Roche continues to explore its potential in breast cancer and other PIK3CA-mutated tumor types. Full OS analysis results will be shared at an upcoming medical meeting.