Company: ARVN
Filing Date: 2025-05-01
Form Type: 10-Q
Source: 0001655759-25-000085
Chunk: 2

Company: ARVINAS, INC.
Filing Date: 2025-05-01
Form: 10-Q
Item: Part I, Item 2
Chunk 2
---
vestrant, both as a single agent and in combination with a cyclin-dependent kinase, or CDK, 4/6 inhibitor.

We, along with Pfizer, have several ongoing clinical trials of vepdegestrant, and Pfizer has a clinical trial which it plans to add a vepdegestrant combination cohort to, which are summarized below.

•Vepdegestrant is currently under investigation; its safety and effectiveness for these investigational uses have not been established. 

•Defined terms in graph above, not defined elsewhere: CDK4/6i, cyclin-dependent kinase 4/6 inhibitor

•Footnotes in graph: a. Data to be presented at 2025 American Society of Clinical Oncology (May 30 – June 3, 2025); b. The trial (NCT04606446) is currently evaluating Pfizer’s KAT6 inhibitor (PF-07248144) in combination with endocrine therapies following CDK4/6 inhibitor treatments; the trial is being operationalized and funded by Pfizer and will now include a vepdegestrant/KAT6 cohort; c. Clinical trials fully enrolled except for ribociclib combination trial.

In the first quarter of 2025, we, along with Pfizer, announced positive topline results from the Phase 3 VERITAC-2 clinical trial in the estrogen receptor 1-mutant, or ESR1m, population. We and Pfizer plan to present detailed results from the VERITAC-2 Phase 3 clinical trial in a late-breaker oral presentation at the 2025 American Society of Clinical Oncology Annual Meeting in the second quarter of 2025, share these data with global regulatory authorities to potentially support regulatory filings also in the second quarter of 2025, and 

21

submit a new drug application to the U.S. Food and Drug Administration for potential approval in the second half of 2025. 

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