From GlobeNewswire: 2025-05-31 08:00:00

Results from the Phase 3 VERITAC-2 clinical trial show vepdegestrant improved progression-free survival by 2.9 months in patients with an estrogen receptor 1 mutation compared to fulvestrant. Vepdegestrant is a first-of-its-kind PROteolysis TArgeting Chimera (PROTAC) evaluated in a Phase 3 trial for breast cancer. The study will be presented at ASCO and published in the New England Journal of Medicine. Vepdegestrant demonstrated a low incidence of gastrointestinal side effects and was generally well tolerated. Arvinas and Pfizer plan to submit an NDA for vepdegestrant in the second half of 2025. The Phase 3 VERITAC-2 clinical trial results presented at ASCO showed a 2.9-month improvement in median progression-free survival with vepdegestrant compared to fulvestrant in second line-plus patients with an ESR1 mutation. Vepdegestrant is the first PROTAC evaluated in a Phase 3 trial to benefit breast cancer patients. Arvinas will discuss these results on June 2. The trial enrolled 624 patients in 26 countries, with 43% having ESR1 mutations. Vepdegestrant, an investigational PROTAC, targets and degrades the estrogen receptor for ER+/HER2- breast cancer with ESR1 mutations in the second line-plus setting. Arvinas has a collaboration with Pfizer for vepdegestrant’s development. The FDA granted vepdegestrant Fast Track designation for the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy. Pfizer Oncology is focused on delivering transformative therapies in common cancers like breast cancer. Pfizer is committed to changing patients’ lives through innovative medicines and vaccines. Pfizer collaborates with health care providers, governments, and local communities to expand access to health care globally. Pfizer applies science and global resources to improve lives and combat diseases. In a Phase 3 VERITAC-2 clinical trial presented at ASCO, vepdegestrant showed a 2.9-month improvement in median progression-free survival compared to fulvestrant in second line-plus patients with an estrogen receptor 1 mutation. This first PROTAC evaluated in a Phase 3 trial for breast cancer also demonstrated good tolerability. Data will be presented at ASCO and published in the New England Journal of Medicine. Arvinas will discuss these results in a conference call on June 2. Pfizer also disclosed plans to submit a New Drug Application for vepdegestrant to the FDA in the second half of 2025.

Sources:
– https://doi.org/10.1200/JCO.22.00338
– https://pubmed.ncbi.nlm.nih.gov/39693591/
– https://ascopubs.org/doi/full/10.1200/JCO.22.02746 The Phase 3 VERITAC-2 clinical trial results show a 2.9-month improvement in median progression-free survival compared to fulvestrant for breast cancer patients with an estrogen receptor 1 mutation. Vepdegestrant, a PROTAC, was well tolerated with few discontinuations and low rates of adverse events. These findings will be presented at ASCO and published in the New England Journal of Medicine. Arvinas will host a conference call on June 2 to discuss the results. The Phase 3 VERITAC-2 clinical trial results revealed a significant 2.9-month improvement in median progression-free survival for patients with an estrogen receptor 1 mutation using Vepdegestrant compared to fulvestrant. The drug was well tolerated with low rates of adverse events, making it the first PROTAC evaluated in a Phase 3 trial to show benefits for breast cancer patients. These findings will be presented at ASCO and published in the New England Journal of Medicine. Arvinas will hold a conference call on June 2 to discuss these groundbreaking results.



Read more at GlobeNewswire: Arvinas and Pfizer’s Vepdegestrant Significantly Improves