Genentech Provides Update on Phase III persevERA Study in ER-positive Advanced Breast Cancer

Core Viewpoint - Genentech's Phase III persevERA study for giredestrant in ER-positive advanced breast cancer did not achieve its primary endpoint of statistically significant improvement in progression-free survival, although a numerical improvement was noted [1] Group 1: Study Results - The persevERA study evaluated giredestrant plus palbociclib against letrozole plus palbociclib in patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer [1] - The study enrolled 992 patients globally, with the primary endpoint being investigator-assessed progression-free survival [2] - Adverse events associated with the giredestrant combination were manageable and consistent with known safety profiles [1] Group 2: Future Developments - Genentech is committed to advancing giredestrant as a potential new standard-of-care endocrine therapy, supported by previous successes in the evERA and lidERA studies [1] - The FDA has accepted the New Drug Application based on evERA data, and lidERA data will be submitted in the coming weeks [1] - The pionERA study, which will evaluate giredestrant in combination with a physician's choice of CDK4/6 inhibitor, is expected to read out in 2027 [1] Group 3: Background on ER-positive Breast Cancer - ER-positive breast cancer accounts for approximately 70% of breast cancer cases, with 2.3 million women diagnosed and 670,000 deaths annually [2] - The complexity of ER-positive breast cancer treatment remains a challenge, with up to a third of patients experiencing disease recurrence after adjuvant endocrine therapy [2] - There is a significant need for more effective treatments to delay clinical progression and reduce treatment burden [2] Group 4: Genentech's Commitment - Genentech has been advancing breast cancer research for over 30 years, aiming to improve outcomes for patients [2] - The company is focused on identifying new biomarkers and treatment approaches for various breast cancer subtypes, including ER-positive breast cancer [2]