Company: ARVN
Filing Date: 2025-02-11
Form Type: 10-K
Source: 0001655759-25-000016
Chunk: 79

Company: ARVINAS, INC.
Filing Date: 2025-02-11
Form: 10-K
Item: Item 1
Chunk 79
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gestrant as a backbone ER-targeting therapy treating the ER+/HER2- metastatic breast cancer, as outlined below: 

a. Pending emerging data and health authority feedback

ER, estrogen receptor; HER, human epidermal growth factor receptor; mBC, metastatic breast cancer; 1L, first-line; 2L second-line 

As part of our global collaboration with Pfizer, we expect to announce topline data for the VERITAC-2 Phase 3 monotherapy 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. We completed enrollment for this clinical trial in the fourth quarter of 2024.

In the first quarter of 2025, we announced that we, as part of our global collaboration with Pfizer, plan to initiate two new Phase 3 combination trials of vepdegestrant in patients with ER+/HER2- metastatic breast cancer in 2025, pending emerging data and regulatory feedback:

•A first-line Phase 3 combination trial with Pfizer’s CDK4 inhibitor, atirmociclib; and

•A second-line Phase 3 combination trial with a CDK/6 inhibitor.

Additional information regarding our progress with respect to each of the vepdegestrant clinical trials is included below in "Item 1. Business—Our Clinical Stage Programs—Oncology Programs—Estrogen Receptor Program: Vepdegestrant for the Treatment of Patients with Locally Advanced or Metastatic ER+/HER2- Breast Cancer".

Hematology Program: ARV-393

ARV-393 is an investigational, orally bioavailable PROTAC designed to degrade BCL6, a transcriptional repressor and a key regulator of normal B-cell maturation and differentiation processes. Deregulation of BCL6 function (e.g., via chromosomal translocation, mutations) may lead to malignant transformation and development of NHL. Prior to the advent of PROTAC technology, the BCL6 protein was considered "undruggable." We believe that ARV-393 PROTAC-mediated degradation of BCL6 may provide an important novel therapeutic option for patients with NHL. 

We are currently enrolling a Phase 1 first-in-human clinical trial of ARV-393 in patients with relapsed/refractory NHL. This is an open-label, multicenter, Phase 1 dose escalation study to evaluate the safety, tolerability