Roche bets on adjuvant promise after giredestrant’s first-line miss

Roche’s oral SERD giredestrant failed to achieve statistical significance in the persevERA first-line trial for HR+/HER2- metastatic breast cancer when combined with palbociclib, but the company remains optimistic about its adjuvant potential and is designing a new CDK4/6–giredestrant study for early-stage disease. Earlier lidERA showed an adjuvant iDFS benefit; OS data are immature. Roche is pursuing ESR1-mutant labeling in second-line work and exploring additional adjuvant combos, with an FDA decision target around late 2026.