Positive phase III results show Roche’s giredestrant significantly improved progression-free survival in ER-positive advanced breast cancer

Core Insights - Roche announced positive results from the phase III evERA study, which evaluated giredestrant in combination with everolimus for ER-positive, HER2-negative breast cancer patients previously treated with CDK 4/6 inhibitors and endocrine therapy [1][2][4] - The study met both co-primary endpoints, showing significant improvement in progression-free survival (PFS) for both intention-to-treat and ESR1-mutated populations compared to standard-of-care therapy [1][5] - Overall survival (OS) data are still immature, but a positive trend was noted, with follow-up continuing for further analysis [1][5] Company Overview - Roche has been a leader in breast cancer research for over 30 years, focusing on developing targeted therapies and innovative treatment options for various breast cancer subtypes [9][10] - The company is committed to delivering effective treatments for ER-positive breast cancer, which accounts for approximately 70% of breast cancer cases globally [2][9] - Giredestrant is an investigational oral selective estrogen receptor degrader (SERD) designed to block estrogen from binding to its receptor, thereby inhibiting cancer cell growth [7][8] Clinical Development - The evERA study is a phase III, randomized, open-label trial assessing the efficacy and safety of giredestrant plus everolimus versus standard endocrine therapy plus everolimus in advanced breast cancer patients [4][5] - The trial specifically enriched for ESR1-mutated patients to evaluate efficacy in this subgroup, where up to 40% of ER-positive patients may have such mutations [5][6] - Giredestrant's clinical development program includes multiple phase III trials across various treatment settings to maximize patient access to innovative therapies [3][8]