Company: ARVN
Filing Date: 2025-06-02
Form Type: 8-K
Source: 0001655759-25-000095
Chunk: 3

Company: ARVINAS, INC.
Filing Date: 2025-06-02
Form: 8-K
Item: Item 8.01
Chunk 3
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 of events having occurred.

◦ Additional secondary endpoints include clinical benefit rate (“ CBR”) and objective response rate (“ ORR”) and duration of response by BICR. In patients with an ESR1 mutation, CBR was 42.1% with vepdegestrant versus 20.2% with fulvestrant [odds ratio 2.88 (95% CI: 1.57 - 5.39); nominal P<0.001] and ORR was 18.6% with vepdegestrant versus 4.0% with fulvestrant [odds ratio 5.45 (95% CI: 1.69 - 22.73); nominal P=0.001]. The median duration of response was not reached.

The Company believes that based on these strong data from VERITAC-2, vepdegestrant has the potential to be a best-in-class monotherapy treatment for patients in the second-line ESR1m setting.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the Company’s future plans with respect to vepdegestrant, including planned engagement with regulatory authorities on next steps to potentially bring vepdegestrant to healthcare providers and their patients, planned submission of an NDA for vepdegestrant to the FDA, and the potential for vepdegestrant to be a best-in class monotherapy treatment for patients in the second-line ESR1m setting. All statements, other than statements of historical facts, contained in this Current Report on Form 8-K, including statements regarding the Company’s strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The word “plan,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements the Company makes as a result of various risks and uncertainties, including the important factors discussed the important factors discussed in the “ Risk Factors” sections contained in the Company’s quarterly and annual reports on file with the U. S. Securities and Exchange Commission. The forward-looking statements contained in this Current Report on Form 8-K reflect the Company’s current