Company: ARVN
Filing Date: 2025-02-11
Form Type: 10-K
Source: 0001655759-25-000016
Chunk: 102

Company: ARVINAS, INC.
Filing Date: 2025-02-11
Form: 10-K
Item: Item 1
Chunk 102
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 initiated dosing in a Phase 1 clinical trial for vepdegestrant. The trial is an open-label dose-escalation study in which we treated patients with locally advanced or metastatic ER+/HER2- breast cancer who had progressed on at least two prior endocrine therapy regimens and a CDK4/6 inhibitor. Eligible patients may have also received up to three prior regimens of cytotoxic chemotherapy. Part A was the dose escalation portion of our Phase 1/2 clinical trial of vepdegestrant and was designed to assess the dose-limiting toxicities, safety, tolerability and pharmacokinetics, or PK, of vepdegestrant monotherapy in patients with locally advanced or metastatic ER+/HER2- breast cancer, as well as measures of anti-tumor activity as secondary endpoints. Enrollment in this cohort is complete. Initial data from Part A of this clinical trial were presented at SABCS 2021 and updated results were presented at the European Society for Medical Oncology, or ESMO, in the fourth quarter of 2023.

Part B (VERITAC): In 2021, we initiated VERITAC, the Phase 2 cohort expansion portion of the vepdegestrant clinical trial. The enrollment of patients is complete. We announced initial results from VERITAC in the fourth quarter of 2022 at 2022 SABCS. In VERITAC, patients were treated with either 200 mg or 500 mg vepdegestrant with a primary endpoint of clinical benefit rate, or CBR. Secondary endpoints included overall response rate, or ORR, duration of response, or DOR, progression free survival, or PFS, and overall survival, as well as safety and pharmacokinetics. As of the data cut-off date of June 6, 2022, 71 patients with locally advanced or metastatic ER+/HER2- breast cancer in the VERITAC expansion cohort were treated once-daily with oral doses of vepdegestrant at 200 mg (n=35) or 500 mg (n=36). All patients were previously treated with CDK 4/6 inhibitors; 79% of patients were previously treated with fulvestrant; 73% of patients were previously treated with chemotherapy; and 45% received chemotherapy in the metastatic setting. Patients in VERITAC had a median of four lines of prior therapies.

At the time of data cutoff (June 6, 202