[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][2][8] - Giredestrant is positioned as a potential new standard of care in the adjuvant setting, particularly as ER-positive breast cancer accounts for approximately 70% of cases diagnosed [2][3][4] 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 [6][8] - The primary endpoint was invasive disease-free survival (iDFS), with key secondary endpoints including overall survival and safety [7][8] Clinical Implications - Giredestrant was well tolerated, with adverse events aligning with its known safety profile, indicating a favorable treatment option for patients who often face recurrence or treatment interruptions [2][3][4] - The results from lidERA, along with previous studies like evERA, support the efficacy of giredestrant across various treatment settings for ER-positive breast cancer [4][8] Market Context - The need for more effective and better-tolerated treatment options is underscored by the fact that up to a third of patients experience recurrence after adjuvant endocrine therapy [3][12] - Roche's commitment to advancing breast cancer research is evident through its extensive clinical development program for giredestrant, which spans multiple treatment settings [5][10][13]