Arvinas to Present Data from the Vepdegestrant Clinical Development Program at the 2025 European Society for Medical Oncology (ESMO) Congress

Rhea-AI Summary

Arvinas (Nasdaq: ARVN) will present new clinical data for vepdegestrant at the ESMO Congress, Oct 17–21, 2025 in Berlin.

Highlights include Phase 3 VERITAC-2 patient-reported outcomes comparing vepdegestrant (VEP) vs fulvestrant (FUL) in ESR1-mutated ER+/HER2− advanced/metastatic breast cancer, presented by Dr. Mario Campone on Oct 20, 2025 at 11:25 CEST (Presentation 489MO, mini oral). Also scheduled is TACTIVE-N, a Phase 2 neoadjuvant study of vepdegestrant vs anastrozole in postmenopausal localized ER+/HER2− breast cancer, presented by Dr. Peter A. Fasching on Oct 19, 2025 at 10:40 CEST (Presentation 293MO, mini oral).

Both abstracts are available in the ESMO online program.

Insights

Clinical development strategist

Phase 3 patient‑reported outcomes will be presented at ESMO; presentation alone is informative but not result‑bearing for valuation.

Arvinas will present new patient‑reported outcomes (PROs) from the Phase 3 VERITAC-2 trial comparing vepdegestrant to fulvestrant in ESR1‑mutant ER+/HER2− advanced breast cancer at the Oct 17-21, 2025 ESMO Congress; a separate Phase 2 neoadjuvant dataset (TACTIVE‑N) will also be presented.

The business mechanism is straightforward: PRO data can influence regulatory and commercial narratives by characterizing tolerability and quality‑of‑life versus an established comparator, and partnership dynamics with Pfizer remain relevant. However, an abstract/presentation notice without numeric outcomes does not change clinical or financial facts by itself, so the immediate informational impact is limited.

Key dependencies and risks include the actual PRO results (magnitude and statistical significance), the context versus clinical endpoints, and how regulators or clinicians interpret patient‑reported benefits. Watch for full abstract details and any press or poster that discloses effect sizes, responder rates, or statistical analyses on or shortly after the presentations on Oct 19, 2025 and Oct 20, 2025.

– Presentation to include new patient-reported outcomes (PRO) data from the Phase 3 VERITAC-2 clinical trial –

NEW HAVEN, Conn., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) today announced that new data for vepdegestrant will be presented at the European Society for Medical Oncology (ESMO) Congress to be held October 17 through 21, 2025, in Berlin, Germany. Vepdegestrant is a novel investigational PROTAC estrogen receptor (ER) degrader which is being developed with Pfizer Inc. (NYSE: PFE) as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting. Ongoing studies are also evaluating vepdegestrant as a monotherapy and as part of combination therapy for ER+/HER2- breast cancer.

The presentation details are as follows:

Title: Patient-reported outcomes (PROs) with vepdegestrant (VEP) vs fulvestrant (FUL) in patients (pts) with estrogen receptor (ER) 1 gene mutated (ESR1m) ER+/human epidermal growth factor receptor 2 (HER2)− advanced breast cancer (aBC) in the phase 3 VERITAC-2 trial
Presenting Author: Dr. Mario Campone
Presentation Number: 489MO
Presentation Type: Mini oral session
Session: Breast cancer, metastatic
Date: Monday, October 20, 2025
Time: 11:25-11:30 CEST

Title: TACTIVE-N: phase 2 study of neoadjuvant vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, or anastrozole in postmenopausal ER+/human epidermal growth factor receptor 2 (HER2)- localized breast cancer (BC)
Presenting Author: Dr. Peter A. Fasching
Presentation Number: 293MO
Presentation Type: Mini oral session
Session: Breast cancer, early stage
Date: Sunday, October 19, 2025
Time: 10:40-10:45 AM CEST

The full abstracts can be accessed via the ESMO online program.

About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) estrogen receptor degrader. Vepdegestrant is being developed as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting. Ongoing studies are also evaluating vepdegestrant as a monotherapy and as part of combination therapy for ER+/HER2- breast cancer.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant. In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the out-licensing and commercialization of vepdegestrant.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vepdegestrant for its use as a monotherapy in the treatment of adults with estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2-), ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. Vepdegestrant has also been granted Fast Track designation by the FDA, supporting the potential for vepdegestrant to offer a meaningful new treatment option for patients with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy.

About Arvinas
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; ARV-102, targeting LRRK2 for neurodegenerative disorders; and ARV-806, targeting KRAS G12D for mutated cancers, including pancreatic and colorectal cancers. 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’s potential as a monotherapy for ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in the second line-plus setting; vepdegestrant’s potential as a monotherapy and as part of combination therapy for ER+/HER2- breast cancer; and Arvinas’ plan, with Pfizer, to jointly select a third party for the out-licensing and commercialization of vepdegestrant. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas’ strategy, future operations, 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: risks related to Arvinas’ expectations regarding the potential clinical benefit of vepdegestrant to patients; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant; 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; whether Arvinas and Pfizer will successfully perform their respective obligations under the collaboration between Arvinas and Pfizer; risks and uncertainties related to the potential out-license of vepdegestrant to a third party; whether the VERITAC-2 clinical trial will meet the secondary endpoint for overall survival; uncertainties relating to regulatory applications and related approval timelines, including with respect to the New Drug Application for vepdegestrant; risks related to seeking FDA approval of vepdegestrant and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; whether FDA or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of vepdegestrant; 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.

Contacts
Investors:
Jeff Boyle
+1 (347) 247-5089
Jeff.Boyle@arvinas.com

Media:
Kirsten Owens
+1 (203) 584-0307
Kirsten.Owens@arvinas.com

FAQ

What data will Arvinas (ARVN) present at ESMO 2025 and when?

Arvinas will present Phase 3 VERITAC-2 PRO data on Oct 20, 2025 at 11:25 CEST and Phase 2 TACTIVE-N data on Oct 19, 2025 at 10:40 CEST.

What is the focus of the VERITAC-2 presentation for ARVN (vepdegestrant)?

VERITAC-2 presentation covers patient-reported outcomes comparing vepdegestrant vs fulvestrant in ESR1-mutated ER+/HER2− advanced breast cancer.

Who are the presenting authors for Arvinas posters at ESMO 2025?

Dr. Mario Campone will present VERITAC-2 (Presentation 489MO) and Dr. Peter A. Fasching will present TACTIVE-N (Presentation 293MO).

Where can investors access the full Arvinas ESMO 2025 abstracts for ARVN?

The full abstracts are available via the ESMO online program on the ESMO Congress website.

What patient populations are included in the ARVN vepdegestrant presentations at ESMO 2025?

Presentations cover ESR1-mutated ER+/HER2− advanced/metastatic breast cancer (VERITAC-2) and postmenopausal localized ER+/HER2− breast cancer (TACTIVE-N).