Company: ARVN
Filing Date: 2025-10-20
Form Type: 8-K
Source: 0001628280-25-045445
Chunk: 1

Company: ARVINAS, INC.
Filing Date: 2025-10-20
Form: 8-K
Item: Item 8.01
Chunk 1
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Item 8.01 Other Events.

On October 20, 2025, the Company issued a press release announcing new PRO data from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant. These data were presented in a mini oral session at ESMO 2025. Vepdegestrant is a novel investigational PROteolysis TArgeting Chimera ("PROTAC") estrogen receptor ("ER") degrader which is being developed with Pfizer Inc. as a potential monotherapy for estrogen receptor 1 ("ESR1") mutated, ER-positive ("ER+)/human epidermal growth factor receptor 2-negative ("HER2-") advanced or metastatic breast cancer previously treated with endocrine-based therapy.

In the VERITAC-2 clinical trial, in patients with ESR1-mutated disease, vepdegestrant demonstrated a reduced risk of deterioration compared to fulvestrant which was statistically significant in several PRO domains including overall health status, pain severity, and functioning (including role, cognitive, emotional, and social functioning), and vepdegestrant consistently showed reduced risk of deterioration versus fulvestrant across all PRO domains. These PRO data from the VERITAC-2 clinical trial support the clinical benefit of vepdegestrant in patients with ESR1-mutated, ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy.

Also presented at ESMO 2025 were results from the TACTIVE-N Phase 2 clinical trial, which evaluated neoadjuvant vepdegestrant in postmenopausal women with ER+/HER2 - localized breast cancer. The results presented at ESMO 2025 showed that neoadjuvant vepdegestrant demonstrated biological and clinical activity in this treatment-naïve, predominantly ESR1 wild-type population of postmenopausal women with ER+/HER2- localized breast cancer.

Item 9.01 Financial Statements and Exhibits.