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Arvinas Announces Results from the VERITAC-2 Trial Selected as Late-Breaking Oral Presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

Key Takeaway: Arvinas, Inc. announced that results from its Phase 3 VERITAC-2 trial will be presented as a late-breaking oral presentation at the 2025 ASCO Annual Meeting. The trial evaluates vepdegestrant versus fulvestrant in treating ER+/HER2- advanced breast cancer. This marks the first detailed presentation of pivotal data for vepdegestrant, an investigational oral PROTAC estrogen receptor degrader. The drug is being co-developed with Pfizer and has received Fast Track designation from the FDA.

Market Sentiment Analysis

POSITIVE FACTORS

  • Vepdegestrant shows promise as a first-in-class investigational treatment.
  • The Phase 3 VERITAC-2 trial results will be presented at a prestigious conference.
  • Vepdegestrant has received Fast Track designation from the FDA.
  • Collaboration with Pfizer enhances development and commercialization prospects.

Full Press Release Details

– Oral presentation will serve as first presentation of detailed results from the Phase 3 VERITAC-2 clinical trial –
NEW HAVEN, Conn., April 23, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) today announced that data from the global Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant versus fulvestrant in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer will be presented as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 – June 3 in Chicago, IL. The presentation includes the first pivotal data for vepdegestrant, a potential first-in-class investigational oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader.
Vepdegestrant is being jointly developed by Arvinas and Pfizer for the treatment of patients with advanced or metastatic ER+/HER2- breast cancer.
Presentation details are as follows:
Title: Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs. fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (aBC): results of the global, randomized, phase 3 VERITAC-2 study
Presenting Author: Erika P. Hamilton, MD, Breast Cancer Research Program, Sarah Cannon Research Institute
Abstract Number: LBA1000
Session Date, Time and Location: Saturday, May 31, 2025, 1:15 PM-4:15 PM CT in Hall B1
Session Type and Title: Oral Abstract Session – Breast Cancer—Metastatic
Late-breaking abstracts will be released at 7:00 am CT / 8:00 am ET on the day of the scientific presentation. Additional information can be found at www.asco.org.
Vepdegestrant is an investigational, orally bioavailable PROTAC (PROteolysis TArgeting Chimera) protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for ER+/HER2- metastatic breast cancer.
In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits.
The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy.
Arvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC (PROteolysis TArgeting Chimera) protein degrader platform, the Company is pioneering the development of protein degradation therapies designed to harness the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; and ARV-102, targeting LRRK2 for neurodegenerative disorders. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: vepdegestrant having the potential to provide clinically meaningful outcomes for thousands of patients with metastatic breast cancer whose tumors harbor estrogen receptor 1 mutations; Arvinas’ and Pfizer’s plans to share data from the Phase 3 VERITAC-2 clinical trial with health authorities, including to potentially support regulatory filings, as well as at medical conferences in 2025; and vepdegestrant’s development as a potential monotherapy and as part of combination therapy across multiple treatment settings for estrogen receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas’ strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “target,” “goal,” “potential,” “will,” “would,” “could,” “should,” “look forward,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Arvinas may not actually achieve the plans, intentions or expectations disclosed in these 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 Arvinas makes as a result of various risks and uncertainties, including but not limited to: whether Arvinas and Pfizer will successfully perform their respective obligations under the collaboration between Arvinas and Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant as a monotherapy and as part of combination therapy; whether Arvinas will be able to successfully conduct and complete development for its other product candidates, including ARV-393 and ARV-102; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant and other product candidates on current timelines or at all; Arvinas’ ability to protect its intellectual property portfolio; Arvinas’ reliance on third parties; whether Arvinas will be able to raise capital when needed; whether Arvinas’ cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the “Risk Factors” section of Arvinas’ Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas’ current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas’ views as of any date subsequent to the date of this release.

Tags

targeted protein degradation

Frequently Asked Questions

What is the VERITAC-2 clinical trial about?

The VERITAC-2 trial evaluates vepdegestrant against fulvestrant in ER+/HER2- advanced breast cancer.

When will the results of the trial be presented?

Results will be presented on May 31, 2025, at the ASCO Annual Meeting.

What is vepdegestrant?

Vepdegestrant is an investigational oral PROTAC estrogen receptor degrader for advanced breast cancer.

Who is developing vepdegestrant?

Vepdegestrant is co-developed by Arvinas and Pfizer for treating advanced breast cancer.

Has vepdegestrant received any designations?

Yes, it has Fast Track designation from the FDA for treating ER+/HER2- advanced cancer.

Last updated: Apr 23, 2025