Company: ARVN
Filing Date: 2025-02-11
Form Type: 10-K
Source: 0001655759-25-000016
Chunk: 96

Company: ARVINAS, INC.
Filing Date: 2025-02-11
Form: 10-K
Item: Item 1
Chunk 96
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 is being evaluated across clinical trials, including clinical trials in breast cancer patients and clinical pharmacology trials in healthy volunteers. In addition to monotherapy clinical trials, vepdegestrant is being evaluated in multiple clinical trials in combination other agents including Pfizer's novel investigational CDK4 inhibitor atirmociclib, CDK4/6 inhibitors such as abemaciclib, ribociclib, palbociclib, the CDK7 inhibitor samuraciclib, everolimus, and other targeted therapies. Vepdegestrant is the first PROTAC ER degrader to enter Phase 3 pivotal trials. We believe vepdegestrant has the potential to become a first-in-class ER-degrading PROTAC in advanced breast cancer and an oral, best-in-class targeted therapy, and the potential to improve clinical outcomes over current standards of care for patients with locally advanced or metastatic ER+/HER2- breast cancer as well as in earlier treatment settings. 

Breast Cancer - Patient Population and Market Opportunity

Breast cancer is the most common cancer diagnosed among women in the United States, other than skin cancers, and the second leading cause of cancer death in women. Approximately one in eight women in the United States will develop invasive breast cancer in their lifetime. The American Cancer Society estimates that in 2025 there will be approximately 316,950 new cases of invasive breast cancer diagnosed in women in the United States. Approximately 70% of all breast cancer cases, including males, are ER+. 

Treatment options for breast cancer depend on many different factors, including the stage of the cancer and whether the cancer cells contain hormone receptors. Patients with locally advanced or metastatic breast cancer are treated with systemic therapy, including hormone therapy, chemotherapy and targeted therapy, either as single-agents or in combination. Patients with locally advanced or metastatic ER+/HER2- breast cancer are often treated with hormone therapy, such as an aromatase inhibitor, typically in combination with targeted drugs such as CDK4/6 inhibitors. In patients with aggressive disease or whose disease continues to progress with a hormonal treatment regimen, chemotherapy may be prescribed. Treatment with chemotherapy is generally postponed for as long as possible due to the potential for severe side effects including neuropathies, nausea, diarrhea, decreased mental capacity and increased risk of infections. 

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A current standard of care for patients with ER+/HER2- locally advanced or metastatic breast cancer who experience progression on first-line therapy is fulvestrant, a SERD, administered as a