Roche's phase III evERA data showed giredestrant significantly improved progression-free survival in people with ER-positive advanced breast cancer

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]