Patient-Reported Outcomes from VERITAC-2 Clinical Trial Support Clinical Benefit of Vepdegestrant in Patients with ESR1-Mutated, ER+/HER2- Advanced or Metastatic Breast Cancer Previously Treated with Endocrine-Based Therapy

Core Insights - Vepdegestrant has shown statistically significant improvements in patient-reported outcomes (PROs) compared to fulvestrant, particularly in quality of life, pain, and daily functioning for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer [1][2][3] Clinical Trial Findings - The Phase 3 VERITAC-2 clinical trial demonstrated that vepdegestrant delayed deterioration in overall health status, pain severity, and various functioning domains compared to fulvestrant [2][3] - The trial enrolled 624 patients, with 270 having ESR1 mutations, and the primary endpoint was progression-free survival (PFS) [7][8] - Vepdegestrant was administered orally once daily, while fulvestrant was given intramuscularly [8] Company Collaboration and Development - Arvinas is collaborating with Pfizer for the co-development and commercialization of vepdegestrant, sharing development costs and profits [10] - The FDA has accepted the New Drug Application (NDA) for vepdegestrant, granting it Fast Track designation, indicating a significant unmet need in the target patient population [11] Additional Clinical Insights - Results from the TACTIVE-N Phase 2 clinical trial indicated that neoadjuvant vepdegestrant showed biological and clinical activity in postmenopausal women with localized ER+/HER2- breast cancer [5] - The data from the VERITAC-2 trial support vepdegestrant's potential as a best-in-class therapy for the specified patient group [4]