Company: ARVN
Filing Date: 2025-03-11
Form Type: 8-K
Source: 0001655759-25-000057
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Company: ARVINAS, INC.
Filing Date: 2025-03-11
Form: 8-K
Item: Item 7.01
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Item 7.01 Regulation FD Disclosure.

On March 11, 2025, Arvinas, Inc. (the “ Company”), along with Pfizer, Inc. ("Pfizer"), announced positive topline results from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive ("ER+"), human epidermal growth factor receptor 2-negative (“ HER2-”) ("ER+/HER2-") advanced or metastatic breast cancer whose disease progressed following prior treatment with cyclin-dependent kinase ("CDK") 4/6 inhibitors and endocrine therapy. Vepdegestrant is an investigational oral PROteolysis TArgeting Chimera ("PROTAC") ER degrader for ER+/HER2- breast cancer being jointly developed by Arvinas and Pfizer and is designed to harness the body’s natural protein disposal system to specifically target and degrade the ER.

The Phase 3 VERITAC-2 trial met its primary endpoint in the estrogen receptor 1-mutant ("ESR1m") population, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival ("PFS") compared to fulvestrant. The results exceeded the pre-specified target hazard ratio of 0.60 in the ESR1m population. The trial did not reach statistical significance in improvement in PFS in the intent-to-treat ("ITT") population.

Overall survival was not mature at the time of the analysis of data, with less than a quarter of the required number of events having occurred. The trial will continue to assess overall survival as a key secondary endpoint. In the trial, vepdegestrant was generally well tolerated and its safety profile was consistent with what has been observed in previous studies. Detailed results from VERITAC-2 will be submitted for presentation at a medical meeting later this year, and these data will be shared with global regulatory authorities to potentially support regulatory filings.

The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.

The information in this Item 7.01, including Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “ Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by