[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on phase III persevERA study in ER-positive advanced breast cancer

Core Insights - Roche announced results from the phase III persevERA Breast Cancer study, which evaluated giredestrant in combination with palbociclib for ER-positive, HER2-negative breast cancer. The study did not achieve its primary objective of statistically significant improvement in progression-free survival compared to letrozole plus palbociclib, although a numerical improvement was noted [1][4][6]. Group 1: Study Results - The persevERA study enrolled 992 patients globally and focused on the efficacy and safety of giredestrant plus palbociclib versus letrozole plus palbociclib as first-line treatment [6]. - Adverse events associated with the giredestrant combination were manageable and consistent with known safety profiles of the individual treatments [1][4]. - The FDA has accepted the New Drug Application based on data from the evERA study, and Roche plans to submit lidERA data in the coming weeks [5][4]. Group 2: Future Development - Roche's Chief Medical Officer expressed confidence in giredestrant's potential as a new standard-of-care endocrine therapy for ER-positive breast cancer, indicating ongoing studies to explore its combination with CDK4/6 inhibitors [2][4]. - The giredestrant clinical development program includes multiple distinct studies targeting various stages of breast cancer, with the pionERA study expected to read out in 2027 [3][4]. Group 3: Market Context - Breast cancer remains a significant global health issue, with 2.3 million women diagnosed and 670,000 deaths annually. ER-positive breast cancer accounts for approximately 70% of cases [8]. - Despite advancements in treatment, ER-positive breast cancer presents challenges due to biological complexity and the risk of disease recurrence [8][10].