Company: ARVN
Filing Date: 2025-02-11
Form Type: 10-K
Source: 0001655759-25-000016
Chunk: 101

Company: ARVINAS, INC.
Filing Date: 2025-02-11
Form: 10-K
Item: Item 1
Chunk 101
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 the second quarter of 2023, we, along with Pfizer, initiated the study-lead in of the VERITAC-3 Phase 3 clinical trial in combination with palbociclib as a first-line treatment in patients with ER+/HER2- locally advanced or metastatic breast cancer. We completed enrollment of patients in the study lead-in of VERITAC-3 in the second quarter of 2024. The decision to prioritize vepdegestrant in combination with atirmociclib in the first-line setting was based on the totality of evidence from the ongoing Phase 1b/2 TACTIVE-K combination clinical trial evaluating vepdegestrant in combination with atirmociclib in the late-line setting and our trials evaluating vepdegestrant in combination with palbociclib. 

VERITAC-2

In the fourth quarter of 2022, we and Pfizer initiated the VERITAC-2 Phase 3 clinical trial with vepdegestrant as a second-line or third line treatment in patients with ER+/HER2- advanced/metastatic breast cancer. VERITAC-2 has two primary endpoints: progression-free survival, or PFS, in the intention-to-treat, or ITT, population, and PFS in the ESR1 mutation sub-population. PFS will be assessed by blinded independent central review. Secondary outcome measures include overall survival; antitumor activity including objective response, duration of response, and clinical benefit rate; and safety and quality of life assessments. 

In the third quarter of 2023, we were awarded Innovation Passport Designation for vepdegestrant by the U.K. Innovative Licensing and Access Pathway Steering Group. In the first quarter 

24

of 2024, the FDA granted Fast Track designation for the investigation of vepdegestrant as a monotherapy in the treatment of adults with ER+/HER- locally advanced or metastatic breast cancer previously treated with endocrine based therapy.

We completed enrollment for this clinical trial in the fourth quarter of 2024. We, along with Pfizer, expect to announce topline data from the VERITAC-2 clinical trial in a topline press release in the first quarter of 2025 and present the full results of the VERITAC-2 clinical trial at a medical conference in 2025.

ARV-471-mBC-101, including Part B (VERITAC)

Part A: In 2019, we