Company: ARVN
Filing Date: 2025-02-11
Form Type: 10-K
Source: 0001655759-25-000016
Chunk: 109

Company: ARVINAS, INC.
Filing Date: 2025-02-11
Form: 10-K
Item: Item 1
Chunk 109
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 and Stub-study C is a clinical trial evaluating vepdegestrant in combination with samuraciclib, a CDK7 inhibitor. 

We and Pfizer initiated the clinical trial of vepdegestrant in combination with abemaciclib in the fourth quarter of 2022 and the clinical trial of vepdegestrant in combination with ribociclib in the first quarter of 2023. We entered into a collaboration agreement with Pfizer and Carrick to evaluate samuraciclib in combination with vepdegestrant in the second quarter of 2023, and initiated the Phase 1b combination clinical trial with Carrick's CDK7 inhibitor in the first quarter of 2024. Enrollment for the abemaciclib study is complete. The TACTIVE-U studies with ribociclib and samuraciclib remain open for enrollment.

In the fourth quarter of 2024, we and Pfizer announced initial safety and pharmacokinetic data (data cut-off: August 30, 2024) from the TACTIVE-U sub-study of abemaciclib at the 2024 SABCS. Preliminary results from 16 patients in the Phase 1b sub-study demonstrated a tolerable safety profile for the combination of abemaciclib 150 mg twice daily with the recommended 200mg once daily Phase 3 monotherapy dose of vepdegestrant. Pharmacokinetic data demonstrated no significant drug-drug interaction between vepdegestrant and abemaciclib and no clinically meaningful effect on abemaciclib exposure was observed. Below are the key findings included in the poster:

•100% of patients had prior treatment with a CDK4/6 inhibitor.

•Tolerability is generally consistent with the profile of abemaciclib and with results previously observed in other clinical trials of vepdegestrant. The most common any grade treatment-related adverse events, or TRAE, were diarrhea, nausea and fatigue. There were no dose-limiting toxicities and no grade 4 or 5 TRAEs.

•There was no significant drug-drug interaction, and data reflected vepdegestrant had no clinically meaningful effect on abemaciclib exposure.

•The CBR (CBR, defined as the rate of confirmed complete response, partial response, or stable disease ≥ 24 weeks) was 62.5% in all CBR-eligible patients (10/16), 62.5% in patients with mutant ESR1 (5