Roche(US:RHHBY) Globenewswireยท2025-09-22 05:00Core 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 [1][4] - The study met both co-primary endpoints, showing significant improvement in progression-free survival (PFS) compared to standard endocrine therapy plus everolimus [1][4] - Overall survival (OS) data are still immature, but a positive trend was noted, with follow-up continuing for further analysis [1][4] Company Overview - Roche has over 30 years of experience in advancing breast cancer research and continues to focus on developing innovative treatments for various breast cancer subtypes [7][8] - The company is committed to delivering tailored treatment approaches and improving patient outcomes through its dual expertise in pharmaceuticals and diagnostics [8][9] Study Details - The evERA study is a phase III, randomized, open-label trial assessing the efficacy and safety of giredestrant plus everolimus versus standard-of-care endocrine therapy plus everolimus in patients with advanced ER-positive breast cancer [3][4] - The trial specifically enriched for ESR1-mutated patients to evaluate efficacy in this population, as up to 40% of patients in the post-CDK inhibitor setting may have these mutations [3][5] Treatment Context - ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and despite treatment advances, it remains challenging due to biological complexity and resistance to therapies [6][4] - Combination therapies like giredestrant plus everolimus target different signaling pathways, potentially improving patient outcomes and minimizing treatment impact on daily life [1][6] Future Plans - Roche plans to submit data from the evERA study to health authorities to expedite the availability of this treatment option for patients [2][4]