Company: ARVN
Filing Date: 2025-02-11
Form Type: 10-K
Source: 0001655759-25-000016
Chunk: 103

Company: ARVINAS, INC.
Filing Date: 2025-02-11
Form: 10-K
Item: Item 1
Chunk 103
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2), vepdegestrant administered at 200 mg (n=35) and 500 mg (n=36) demonstrated:

•Antitumor activity in 100% CDK4/6 inhibitor-pretreated patients, as measured by a CBR of 38% (total n=71) in all patients and 51.2% in patients with mutant ESR1 tumors (n=41).

•Preliminary median progression-free survival, or mPFS, of 3.7 months, a key secondary endpoint, in all evaluable patients and 5.7 months in patients with mutant ESR1 tumors (n=41).

•A favorable tolerability profile, with the majority of treatment-related adverse events, or TRAEs, reported as Grade 1 or 2.

In the fourth quarter of 2022, we also announced that in post-hoc analysis from the Phase 2 cohort expansion portion of the VERITAC Phase 1/2 study, a patient subgroup (n=8) with no prior treatment with fulvestrant or chemotherapy in the metastatic setting, which approximated the expected VERITAC-2 Phase 3 trial population, achieved a CBR (rate of confirmed complete response, confirmed partial response, or stable disease ≥ 24 weeks) of 62.5%. All patients were previously treated with CDK 4/6 inhibitors and while the subgroup in the post-hoc analysis was not actively selected by ESR1 status, all 8 patients harbored ESR1 mutations by circulating tumor DNA analysis. mPFS for patients in the post-hoc analysis had not been reached as of the fourth quarter data analysis. Three of the 8 patients discontinued as of November 2022; the 5 continuing on therapy had treatment durations of 8-14 months.

In the fourth quarter of 2023, we and Pfizer presented a VERITAC Phase 2 dose expansion update at 2023 SABCS. The Phase 2 monotherapy dose expansion of the ARV-471-mBC-101 study analyzed the safety, efficacy, and tolerability of vepdegestrant among 35 heavily pre-treated patients 

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with locally advanced or metastatic ER+/HER2- breast cancer. The update included 12 months of additional follow-up data, and the tolerability and efficacy profile remained largely consistent with previous data disclosures. In addition, in post-hoc analysis, of the eight patients in the VERITAC Phase 2