Arvinas and Pfizer Announce Positive Topline Results from Phase 3 VERITAC-2 Clinical Trial

Core Insights - The Phase 3 VERITAC-2 clinical trial demonstrated that vepdegestrant significantly improved progression-free survival (PFS) in the estrogen receptor 1-mutant (ESR1m) population compared to fulvestrant, achieving a hazard ratio of 0.60 [1][2] - Vepdegestrant is the first PROTAC degrader to show clinical benefit in a Phase 3 trial, indicating its potential as a first-in-class treatment for advanced or metastatic breast cancer [1][3] Company Overview - Arvinas, Inc. and Pfizer Inc. are jointly developing vepdegestrant, an investigational oral PROTAC ER degrader targeting ER+/HER2- breast cancer [4][10] - The FDA granted Fast Track designation for vepdegestrant, facilitating its development for patients previously treated with endocrine therapy [4][10] Clinical Trial Details - The VERITAC-2 trial enrolled 624 patients across 26 countries, focusing on those with ER+/HER2- advanced or metastatic breast cancer who had previously received CDK4/6 inhibitors and endocrine therapy [7][8] - The primary endpoint was PFS, with overall survival being a key secondary endpoint that will continue to be assessed [3][8] Patient Population and Disease Context - Approximately 2.3 million new breast cancer cases were reported globally in 2022, with ER+/HER2- breast cancer accounting for about 70% of all cases [5] - Nearly 30% of women diagnosed with early-stage breast cancer may develop metastatic breast cancer, with ESR1 mutations found in approximately 40% of patients in the second-line setting [6]