- Giredestrant met its primary endpoint in the lidERA phase III trial.
- The study focused on ER-positive, HER2-negative early-stage breast cancer.
- Data will be presented at an upcoming medical meeting.
- ER-positive breast cancer accounts for about 70% of cases.
Study Overview
Roche announced positive phase III results from the lidERA Breast Cancer study, evaluating giredestrant as an adjuvant endocrine treatment for ER-positive, HER2-negative, early-stage breast cancer. The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in invasive disease-free survival compared to standard-of-care endocrine therapy.
Significance
Giredestrant is the first selective oestrogen receptor degrader (SERD) to demonstrate a significant benefit in the adjuvant setting. The majority of breast cancer cases are diagnosed at an early stage, with ER-positive breast cancer accounting for approximately 70% of cases.
Safety and Tolerability
Overall survival data were immature at the time of interim analysis, but a positive trend was observed. Giredestrant was well tolerated, with adverse events consistent with its known safety profile and no unexpected safety findings.
Next Steps
Data from the lidERA study will be presented at an upcoming medical meeting and shared with health authorities globally. The aim is to bring this potential treatment option to patients worldwide, addressing the need for more effective and better-tolerated options to enhance adherence and prevent or delay disease recurrence.
