Company: ARVN
Filing Date: 2025-02-11
Form Type: 10-K
Source: 0001655759-25-000016
Chunk: 119

Company: ARVINAS, INC.
Filing Date: 2025-02-11
Form: 10-K
Item: Item 1
Chunk 119
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) activity in late-line settings suggested additional potential benefit in earlier-line, less pretreated patients. As such, early in the fourth quarter of 2023, we determined to prioritize the initiation of a Phase 3 clinical trial with luxdegalutamide (ARV-766) in mCRPC instead of the previously planned Phase 3 clinical trial for bavdegalutamide. While we expect to continue ongoing trial activities with bavdegalutamide (ARV-110-101 and ARV-110-103), we will not be enrolling new patients in these clinical trials and expect to wind down our bavdegalutamide program after completion of these clinical trials.

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In the second quarter of 2024, we entered into and closed the Novartis Transaction, including both the Novartis License Agreement and the Novartis Asset Agreement with Novartis. Pursuant to the Novartis License Agreement, we granted Novartis an exclusive worldwide license for the development, manufacture and commercialization of ARV-766, our second generation PROTAC AR degrader for patients with prostate cancer and, as of December 31, 2024, we have completed the transition of our ongoing and planned clinical trials of luxdegalutamide (ARV-766) to Novartis. Pursuant to the Novartis Asset Agreement, we sold Novartis all of our rights, title and interest in our PROTAC protein degrader targeting AR-V7, a splice variant of the AR. 

Prostate Cancer - Patient Population and Market Opportunity

In the United States, prostate cancer is the second leading cause of cancer death in men. Current estimates predict that one in eight men will be diagnosed with prostate cancer in their lifetime. The American Cancer Society estimates that in 2025 in the United States there will be approximately 313,780 new cases of prostate cancer and approximately 35,770 deaths from the disease. Prostate cancer is the second-leading cause of cancer death in American men, behind only lung cancer. The American Cancer Society estimates that about one in 44 men will die of prostate cancer. Men with mCRPC have a poor prognosis and a predicted survival rate of just over two years from the initial time of progression. 

Treatment options for prostate cancer depend on many different factors, including the stage of the cancer. Castration-resistant prostate cancer is defined by disease progression despite androgen deprivation therapy, or ADT, and is often indicated by rising levels of PSA.