Arvinas, Inc. and Pfizer Inc. announced detailed results from the Phase 3 VERITAC-2 clinical trial for vepdegestrant monotherapy, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine. The trial evaluated vepdegestrant in patients with ESR1-mutant, ER+/HER2- advanced or metastatic breast cancer.
Vepdegestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) among patients with an ESR1 mutation, reducing the risk of disease progression or death by 43% compared to fulvestrant (Hazard Ratio=0.57; 2-sided P<0.001). The median PFS was 5.0 months with vepdegestrant versus 2.1 months with fulvestrant.
The drug was generally well tolerated, with a safety profile consistent with previous studies and low rates of gastrointestinal adverse events. Clinical benefit rate was 42.1% versus 20.2% and objective response rate was 18.6% versus 4.0% in ESR1-mutant patients. These strong data support vepdegestrant's potential as a best-in-class monotherapy treatment in the second-line ESR1-mutant setting, with a New Drug Application (NDA) submission planned for the second half of 2025.
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