European Commission approves Roche’s Itovebi for people with ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation

Roche has announced that the European Commission has approved Itovebi (inavolisib) in combination with palbociclib and fulvestrant for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. This approval addresses an urgent unmet need, as up to 40% of ER-positive breast cancers have a PIK3CA mutation and are associated with poor prognosis. The approval is based on results from the phase III INAVO120 trial, which showed a 57% reduction in the risk of disease worsening or death with the Itovebi-based regimen compared with palbociclib and fulvestrant alone. The Itovebi-based regimen was well tolerated, with no new safety signals observed. The final overall survival analysis showed a 33% reduction in the risk of death with the Itovebi-based regimen. Itovebi is the first PI3K-targeted therapy to significantly extend survival, highlighting the need for biomarker testing at diagnosis. Itovebi is currently being investigated in three company-sponsored phase III studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations. The Itovebi-based regimen is also approved in several countries, including the United States, Switzerland, Canada, Australia, United Arab Emirates, China, and Taiwan. Roche is committed to advancing breast cancer research and has been working to identify new biomarkers and approaches to treatment for other subtypes of the disease. The company is dedicated to sustainability and has set a goal to achieve net zero by 2045.