Roche bets on adjuvant promise after giredestrant’s first-line miss
TL;DR
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.
- ASCO: Roche, head held high, details oral SERD's first-line flop in breast cancer Fierce Biotech
- Roche’s giredestrant secures FDA priority review for breast cancer Yahoo
- ASCO26: 'Blunting' effect of CDK4/6 inhibitor may have downed Roche's persevERA study of oral SERD FirstWord Pharma
- #ASCO26: Roche details narrow failure of breast cancer pill trial Endpoints News
- Giredestrant Plus Palbociclib Yields Numerical PFS Benefit in ER+, HER2– Advanced Breast Cancer OncLive
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