Genentech announces evERA study meets both co-primary endpoints

Genentech, a member of Roche (RHHBY), announced results from the Phase III evERA study evaluating investigational giredestrant in combination with everolimus in people with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer previously treated with a cyclin-dependent kinase 4/6 inhibitor and endocrine therapy. The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival in both the intention-to-treat and ESR1-mutated populations, compared with standard-of-care endocrine therapy plus everolimus. Overall survival data were immature, but a clear trend was observed. Follow-up continues to the next OS analysis. The giredestrant combination was well tolerated. Adverse events were consistent with the known safety profiles of the individual study treatments, and no new safety signals were observed. Data from the evERA study will be submitted to health authorities with the view of bringing this potential treatment option to patients as soon as possible.