The phase III evERA study met its co-primary endpoints, showing giredestrant plus everolimus provided significant benefit in advanced ER-positive breast cancer patients previously treated with a CDK inhibitor. This all-oral combination demonstrated a statistically significant improvement in progression-free survival in both the intention-to-treat and ESR1-mutated populations compared to standard of care plus everolimus. While overall survival data is still immature, a positive trend was observed, and follow-up continues. The giredestrant combination was found to be well tolerated, with adverse events consistent with known safety profiles of the individual drugs; no new safety signals were identified. This marks the first positive head-to-head Phase III trial evaluating an all-oral selective estrogen receptor degrader (SERD) regimen against a standard of care combination. Roche plans to present these data at an upcoming medical meeting and share them with health authorities. These results are important for ER-positive breast cancer, which constitutes about 70% of cases and is challenging to treat due to biological complexity and resistance to endocrine therapies. The availability of this oral combination could minimize treatment impact on patients' lives. Roche's extensive giredestrant development program aims to deliver innovative medicines to more patients with ER-positive breast cancer.