Overview
- An interim analysis of the Phase 3 lidERA study found giredestrant delivered a clinically meaningful improvement in invasive disease-free survival versus standard endocrine therapy after surgery in ER-positive, HER2-negative early breast cancer.
- Overall survival was not mature but showed a positive trend at the analysis, and the oral SERD was reported to be well tolerated with no unexpected safety findings.
- Roche says giredestrant is the first oral SERD to show benefit in the adjuvant setting, with lidERA enrolling more than 4,100 medium- or high-risk stage I–III patients globally.
- Full results will be presented at an upcoming medical meeting, with data to be shared with health authorities as Roche pursues approval.
- Roche shares rose about 6% to an eight-month high on the news, as analysts flagged a multibillion-dollar opportunity, including estimates near $5 billion annually, while rivals such as AstraZeneca test competing SERDs.