Overview
- The evERA trial met co-primary endpoints, reducing the risk of progression or death by 62% in ESR1‑mutated disease and 44% in the overall population.
- Median progression-free survival reached 9.99 months versus 5.45 months in ESR1‑mutant tumors and 8.77 months versus 5.49 months in the intent‑to‑treat group.
- The global study enrolled 373 patients post‑CDK4/6 inhibitor therapy and compared an all‑oral giredestrant plus everolimus regimen against standard endocrine therapy plus everolimus in a head‑to‑head design.
- An exploratory analysis in ESR1‑negative tumors showed no significant PFS advantage, though response rates and duration of response favored the giredestrant combination.
- Safety was described as manageable, with higher discontinuations on the investigational arm (17% vs 11.8%) and expected adverse events such as stomatitis, diarrhea, and anemia; overall survival remains immature but trends favorable, and Roche will share data with health authorities.