[Ad hoc announcement pursuant to Art. 53 LR] Roche's giredestrant becomes the first oral SERD to show superior invasive disease-free survival in early breast cancer

Core Insights - Roche announced positive phase III results from the lidERA Breast Cancer study, demonstrating that giredestrant significantly improves invasive disease-free survival compared to standard endocrine therapy for early-stage ER-positive, HER2-negative breast cancer [1][5][10] - Giredestrant is positioned as a potential new standard of care for early-stage breast cancer, addressing the need for more effective and better-tolerated treatment options [2][3][6] Study Details - The lidERA study is a phase III, randomized, open-label trial involving over 4,100 patients with medium- or high-risk stage I-III ER-positive, HER2-negative breast cancer [4][10] - The primary endpoint was invasive disease-free survival (iDFS), with key secondary endpoints including overall survival and safety [4] Clinical Significance - Approximately 70% of breast cancer cases are ER-positive, highlighting the importance of giredestrant in improving outcomes for a significant patient population [2][6] - The study's results indicate a clear positive trend in overall survival, although data were immature at the time of interim analysis [1][3] Safety Profile - Giredestrant was well tolerated, with adverse events consistent with its known safety profile and no unexpected safety findings reported [1][5] Broader Context - Roche has a long-standing commitment to breast cancer research, having advanced the field for over 30 years and focusing on innovative treatments for various breast cancer subtypes [7][8] - The company is actively pursuing multiple phase III clinical trials for giredestrant across different treatment settings, reflecting its dedication to improving patient outcomes [6][10]