Genentech’s Phase III evERA data showed giredestrant improved PFS survival

Genentech, a member of the Roche (RHHBY) Group, announced positive results from the Phase III evERA Breast Cancer study. Data showed giredestrant in combination with everolimus significantly reduced the risk of disease progression or death by 44% and 62% in the intention-to-treat, ITT, and ESR1-mutated populations, respectively, compared with standard-of-care endocrine therapy plus everolimus. The evERA study is evaluating the investigational giredestrant combination in people with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer previously treated with cyclin-dependent kinase, CDK, 4/6 inhibitor and endocrine therapy. The results are being presented in an oral session at the European Society for Medical Oncology Congress 2025. The giredestrant combination demonstrated a statistically significant and clinically meaningful improvement in PFS compared with standard-of-care endocrine therapy plus everolimus. In the ITT population, the median PFS was 8.77 months compared with 5.49 months in the giredestrant and comparator arm, respectively. Giredestrant in combination with everolimus also demonstrated improvements in key secondary endpoints.