Company: ARVN
Filing Date: 2025-02-11
Form Type: 10-K
Source: 0001655759-25-000016
Chunk: 108

Company: ARVINAS, INC.
Filing Date: 2025-02-11
Form: 10-K
Item: Item 1
Chunk 108
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 adverse events, or TRAEs, ≥10% of neutropenia (91%) and decreased white blood cell count (15%); no grade 5 TRAEs or febrile neutropenia were reported.

•The majority of Grade 4 neutropenia events occurred in the first cycle of treatment and occurrences of Grade 3/4 neutropenia decreased following palbociclib dose reductions as described in the prescribing label.

•The safety profile of vepdegestrant in combination with palbociclib was otherwise consistent with the profile of palbociclib and what has been observed in other clinical trials for vepdegestrant. Three of 46 patients discontinued palbociclib due to neutropenia including one out of 21 patients treated with the RP3D of vepdegestrant (200 mg) plus palbociclib 125 mg.

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TACTIVE-K 

 In the third quarter of 2023, we received a Study May Proceed letter from the FDA for the planned Phase 1b/2 clinical trial evaluating vepdegestrant in combination with Pfizer's CDK4 inhibitor, atirmociclib, and we initiated this trial in the fourth quarter of 2023. In the first quarter of 2024, we initiated dosing for TACTIVE-K. We expect to continue to enroll patients to the TACTIVE-K Phase 2 clinical trial in 2025 and evaluate preliminary data from this clinical trial. We expect to submit initial Phase 1b data for presentation at medical conference. 

TACTIVE-N

In the fourth quarter of 2022, we initiated sites for TACTIVE-N, a Phase 2 clinical trial with vepdegestrant as a monotherapy in patients with early breast cancer in the neoadjuvant setting. We completed enrollment of patients in this clinical trial in the first quarter of 2024. 

TACTIVE-U

The TACTIVE-U umbrella clinical trial is divided into separate sub-studies focused on learning about the safety and efficacy of the investigational medicine vepdegestrant when given together with other medicines for potential treatment of advanced or metastatic breast cancer that has worsened after prior treatment. Sub-Study A is a clinical trial evaluating vepdegestrant in combination with abemaciclib, a CDK4/6 inhibitor; Sub-Study B is a clinical trial evaluating vepdegestrant in combination with ribociclib, a CDK4/6 inhibitor;