Roche reported detailed phase 3 data showing its oral selective estrogen receptor degrader (SERD) giredestrant improved progression-free survival versus standard-of-care endocrine therapy in metastatic ER-positive, HER2-negative breast cancer. The evERA trial met co-primary endpoints in both the intention-to-treat and ESR1-mutant populations, with larger benefit in the ESR1-mutated cohort. Roche presented the data at ESMO and signaled plans to position giredestrant broadly across patient subgroups and lines of therapy. The results help distinguish Roche’s oral SERD from injectable degraders and may affect competitive dynamics with established endocrine agents and other oral SERDs in development. Regulators will now weigh the totality of efficacy and safety data to determine labeling and patient selection.