Basel, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the Phase III lidERA Breast Cancer study, evaluating investigational giredestrant as an adjuvant endocrine therapy for patients with estrogen receptor (ER)-positive, HER2-negative early-stage breast cancer.
At the pre-specified interim analysis, giredestrant significantly reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy (hazard ratio 0.70, 95% CI 0.57-0.87, p=0.0014). These data were presented at the 2025 San Antonio Breast Cancer Symposium and included in the official press program.
Key Highlights:
- At three years, 92.4% of patients receiving giredestrant were alive and free of invasive disease versus 89.6% in the standard-of-care arm.
- Giredestrant also demonstrated a 31% reduction in distant recurrence-free interval (HR=0.69, 95% CI 0.54-0.89).
- Benefits were consistent across all clinically relevant subgroups.
- The treatment was well tolerated, with manageable adverse events consistent with the known safety profile.
Expert Comments:
“After almost 25 years, giredestrant has demonstrated superiority over existing endocrine therapies in the curative setting, highlighting its potential as a new standard-of-care for patients with ER-positive early-stage breast cancer,” said Dr. Aditya Bardia, lidERA principal investigator and Director of Breast Oncology Program at UCLA.
“The efficacy observed in lidERA underscores giredestrant’s potential to become a new standard-of-care endocrine therapy, where the chance for cure is highest,” said Dr. Levi Garraway, Roche Chief Medical Officer and Head of Global Product Development.
About the lidERA Study:
- Phase III, multicenter, randomized, open-label trial evaluating adjuvant giredestrant versus standard-of-care endocrine therapy in patients with medium- to high-risk ER-positive, HER2-negative stage I-III breast cancer.
- Over 4,100 patients enrolled.
- Primary endpoint: invasive disease-free survival (iDFS).
- Key secondary endpoints: overall survival, disease-free survival, and safety.
About Giredestrant:
Giredestrant is an investigational oral selective estrogen receptor degrader (SERD) designed to block estrogen from binding to its receptor, promoting receptor degradation and inhibiting cancer cell growth. The compound is being investigated across multiple treatment settings in ER-positive breast cancer, including early-stage, locally advanced, and metastatic disease.
About ER-Positive Breast Cancer:
- Accounts for approximately 70% of all breast cancer cases.
- Up to one-third of patients experience recurrence after adjuvant endocrine therapy.
- Effective, well-tolerated therapies are urgently needed to improve adherence and reduce disease recurrence.
About Roche:
Founded in 1896 in Basel, Switzerland, Roche is a global leader in biotechnology and in-vitro diagnostics, pioneering personalized healthcare and innovative therapies to improve patient outcomes worldwide.
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