Arvinas announces FDA approval of VEPPANU for ESR1m, ER+/HER2- ABC

Arvinas (ARVN) with its partner Pfizer (PFE), announced that the U.S. Food and Drug Administration has granted approval for VEPPANU for the treatment of adults with estrogen receptor-positive/human epidermal growth factor receptor 2-negative, estrogen receptor 1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. This approval marks the first time the FDA has approved a PROteolysis TArgeting Chimera, a type of heterobifunctional protein degrader therapy. VEPPANU was discovered by Arvinas and jointly developed by Arvinas and Pfizer. FDA approval was granted based on data from VERITAC-2, a global, randomized, open-label, pivotal Phase 3 clinical trial evaluating vepdegestrant versus fulvestrant. In the trial, among patients with an ESR1 mutation, vepdegestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, reducing the risk of disease progression or death by 43% compared to fulvestrant. Median PFS was 5 months in the vepdegestrant arm and 2.1 months in the fulvestrant arm. Overall survival was immature with 16% of deaths in this population at the time of the PFS analysis. The majority of adverse events with vepdegestrant were low grade and the most common adverse reactions, including laboratory abnormalities, were decreased white blood cells, increased AST, musculoskeletal pain, fatigue, decreased hemoglobin, decreased neutrophils, increased ALT, increased alkaline phosphatase, nausea, decreased blood potassium, increased bilirubin, decreased appetite, electrocardiogram QT prolonged, decreased platelets, and constipation. Arvinas and Pfizer intend to jointly identify and select a third-party partner with the capabilities and expertise to maximize the commercial potential of VEPPANU. The companies are on track to announce selection of a third party.