Core Insights - Roche announced positive results from the phase III evERA Breast Cancer study, showing that giredestrant combined with everolimus significantly reduced the risk of disease progression or death by 44% in the intention-to-treat (ITT) population and 62% in the ESR1-mutated population compared to standard-of-care endocrine therapy plus everolimus [1][4] Study Results - The evERA study evaluated giredestrant in patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer previously treated with CDK 4/6 inhibitors and endocrine therapy [1][5] - The median progression-free survival (PFS) was 8.77 months for the giredestrant group versus 5.49 months for the comparator in the ITT population, and 9.99 months versus 5.45 months in the ESR1-mutated population [3][4] - Overall survival (OS) data were immature, but a positive trend was observed in both populations [3][4] Safety and Tolerability - The giredestrant combination was well tolerated, with no new safety signals reported, including no instances of photopsia [4][3] - Adverse events were manageable and consistent with the known safety profiles of the individual medicines [3][4] Clinical Need and Implications - There is a high unmet need for effective treatments for patients who become resistant to endocrine therapies and CDK inhibitors [2][3] - Giredestrant plus everolimus could potentially become a new standard-of-care treatment in the post-CDK inhibitor setting [2][4] Company Commitment - Roche has a comprehensive clinical development program for giredestrant, reflecting its commitment to delivering innovative treatments for ER-positive breast cancer [6][8] - The company has been advancing breast cancer research for over 30 years, focusing on addressing the complexities of all breast cancer subtypes [8][10]

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]

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 [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]