Company: ARVN
Filing Date: 2025-01-10
Form Type: 8-K
Source: 0001655759-25-000004
Chunk: 1

Company: ARVINAS, INC.
Filing Date: 2025-01-10
Form: 8-K
Item: Item 8.01
Chunk 1
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Item 8.01 Other Events.

On January 10, 2025, the Company announced updated guidance for the planned first- and second-line Phase 3 combination clinical trials for vepdegestrant in patients with locally advanced or metastatic ER+/HER2- breast cancer, certain upcoming milestones anticipated in 2025 and provided a corporate update. Vepdegestrant is an investigational, orally bioavailable PROteolysis TArgeting Chimera ("PROTAC") ER degrader designed to harness the body’s natural protein disposal system to specifically target and degrade the ER and is being co-developed by the Company and Pfizer, Inc. (“ Pfizer”).

The Company is on track to announce, along with Pfizer, topline data for the VERITAC-2 Phase 3 monotherapy clinical trial in patients with second-line-plus ER+/HER2- metastatic breast cancer (“mBC”) in the first quarter of 2025. In addition, as part of the Company’s global collaboration with Pfizer, in 2025, pending emerging data and regulatory feedback, the companies plan to initiate two new Phase 3 combination trials of vepdegestrant in patients with ER+/HER2- mBC:

◦ a first-line Phase 3 combination clinical trial with Pfizer’s novel investigational CDK4 inhibitor, atirmociclib; and

◦ a second-line Phase 3 combination clinical trial with a CDK4/6 inhibitor.

With the prioritization of the vepdegestrant plus atirmociclib combination for the first-line setting, the VERITAC-3 clinical trial evaluating vepdegestrant plus palbociclib in the first-line will not proceed beyond the study lead-in.

The Company also announced that it recently initiated a Phase 1 clinical trial with PROTAC leucine-rich repeat kinase 2 (“ LRRK2”) protein degrader ARV-102 in patients with Parkinson’s disease and that, in 2025, the Company plans to:

• present single-ascending dose data from the ongoing Phase 1 clinical trial of ARV-102 in healthy volunteers in an oral session at the Alzheimer’s Disease/Parkinson’s Disease conference in Vienna, Austria, taking place from April 1-4, 2025;

• complete enrollment and present initial data from the ongoing Phase 1 clinical trial of ARV-102 in patients with Parkinson’s disease;

• present initial data from the ongoing Phase 1 clinical trial of