Arvinas, Inc. (NASDAQ: ARVN) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Vepdegestrant, in partnership with Pfizer Inc. (NYSE: PFE), for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. This submission is supported by the pivotal Phase 3 Veritac-2 clinical trial (NCT05654623), which evaluated Vepdegestrant versus Fulvestrant.
The Veritac-2 trial enrolled 624 patients in 25 countries who had previously received treatment with a CDK4/6 inhibitor plus endocrine therapy. Notably, 43% of patients had ESR1 mutations detected. The primary endpoint of the trial was progression-free survival (PFS) in the ESR1-mutation and intent-to-treat populations as determined by blinded independent central review, with overall survival as the key secondary endpoint.
Results from the Veritac-2 study were recently presented in a late-breaking oral presentation at the American Society of Clinical Oncology (ASCO) 2025 annual meeting and were selected for the ASCO press briefing and for Best of ASCO. Additionally, detailed results were simultaneously published in the New England Journal of Medicine.
Vepdegestrant, an investigational, orally bioavailable PROTAC (Proteolysis Targeting Chimera) protein degrader, is designed to specifically target and degrade the estrogen receptor (ER). It is being developed as a potential monotherapy for ER+/HER2 advanced or metastatic breast cancer with ESR1 mutations in the second line-plus setting. The FDA has granted Vepdegestrant fast track designation as a monotherapy in the treatment of adults with ER+/HER2 advanced or metastatic breast cancer previously treated with endocrine-based therapy.
Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC protein degrader platform, the company is pioneering the development of protein degradation therapies designed to selectively and efficiently degrade and remove disease-causing proteins. The company is currently progressing multiple investigational drugs through clinical development programs, including Vepdegestrant targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2* breast cancer. Following these announcements, the company's shares moved 8.31%, and are now trading at a price of $7.495. For more information, read the company's full 8-K submission here.
