Company: ARVN
Filing Date: 2025-02-11
Form Type: 10-K
Source: 0001655759-25-000016
Chunk: 110

Company: ARVINAS, INC.
Filing Date: 2025-02-11
Form: 10-K
Item: Item 1
Chunk 110
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/8), and 62.5% in patients with wild-type ESR1 (5/8).

•The ORR in evaluable patients was 26.7% overall (4/15), 37.5% in patients with mutant ESR1 (3/8), and 14% in patients with wild-type ESR1 (1/7).

•Five patients remained on study treatment as of the August 30, 2024 data cut-off.

28

These data support the ongoing Phase 2 portion of the TACTIVE-U clinical trial, which is evaluating full dose abemaciclib (150mg twice daily) in combination with vepdegestrant (200 mg once daily) in post-CDK4/6 inhibitor treated advanced breast cancer.

We expect to continue to collect safety and efficacy data from ongoing TACTIVE-U clinical trial sub-studies evaluating combinations of vepdegestrant with abemaciclib, ribociclib, or samuraciclib in 2025 and submit key data for presentation at a medical conference. 

TACTIVE-E

In the third quarter of 2022, we initiated TACTIVE-E, a Phase 1b clinical trial with vepdegestrant in combination with everolimus, a mammalian target of rapamycin protein inhibitor, in patients with metastatic breast cancer. Enrollment of patients for this clinical trial is complete. 

I-SPY-2

In the second quarter of 2023, we announced the inclusion of vepdegestrant in the I-SPY-2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) Endocrine Optimization Platform (EOP) trial sponsored by Quantum Leap. The I-SPY-2 EOP trial includes three arms containing vepdegestrant; a monotherapy arm, a vepdegestrant plus letrozole arm, and a vepdegestrant plus abemaciclib arm. We announced inclusion of the abemaciclib arm in the third quarter of 2023. 

Other Clinical Trials

In the third quarter of 2022, we initiated, with Pfizer, a Phase 1b trial of vepdegestrant as a monotherapy in Japanese patients.

Also, in the fourth quarter of 2024, we presented data from the Phase 1 clinical pharmacology study of vepdegestrant in combination with midazolam to access potential for drug-to-dr