Company: ARVN
Filing Date: 2025-06-02
Form Type: 8-K
Source: 0001655759-25-000095
Chunk: 1

Company: ARVINAS, INC.
Filing Date: 2025-06-02
Form: 8-K
Item: Item 8.01
Chunk 1
---
Item 8.01 Other Events.

On May 31, 2025, the Company, along with Pfizer, announced detailed results from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant as a monotherapy versus fulvestrant in adults with ER+/HER2- advanced or metastatic breast cancer whose disease progressed following prior treatment with CDK4/6 inhibitors and endocrine therapy. Vepdegestrant is an investigational PROTAC ER degrader for ER+/HER2- breast cancer being jointly developed by the Company and Pfizer and is designed to harness the body’s natural protein disposal system to specifically target and degrade the ER. These detailed results, which follow the March 11, 2025 announcement of the topline results from the Phase 3 VERITAC-2 clinical trial, were highlighted in the ASCO® press briefing and selected for Best of ASCO, and were presented in a late-breaking oral presentation and were simultaneously published in theNew England Journal of Medicine on May 31, 2025. The Company and Pfizer plan to engage with regulatory authorities on next steps to potentially bring vepdegestrant to healthcare providers and their patients, and also plan to submit a New Drug Application (“ NDA”) for vepdegestrant to the U. S. Food & Drug Administration (“ FDA”) in the second half of 2025.

Clinical Trial Design

The Phase 3 VERITAC-2 clinical trial is a global randomized study evaluating the efficacy and safety of vepdegestrant as a monotherapy compared to fulvestrant in patients with ER+/HER2- advanced or metastatic breast cancer. The trial enrolled 624 patients at sites in 26 countries who had previously received treatment with a CDK4/6 inhibitor plus endocrine therapy.  Patients were randomized to receive either vepdegestrant once daily, orally on a 28-day continuous dosing schedule, or fulvestrant, administered intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each 28-day cycle starting from Day 1 of Cycle 2. The primary endpoint was progression-free survival (“ PFS”) in the intent-to-treat (“ ITT”) and estrogen receptor 1 mutation (“ ESR1m”) populations as determined by blinded independent central review (“ BICR”). Overall survival (“ OS”) is the key secondary endpoint.

Detailed Clinical Trial Results

Detailed results from the Phase 3 VERITAC-