Arvinas Announces Data Presentations from the Vepdegestrant (ARV-471) Clinical Development Program at the 2025 San Antonio Breast Cancer Symposium (SABCS)

Rhea-AI Summary

Arvinas (Nasdaq: ARVN) announced multiple abstracts on vepdegestrant (ARV-471) accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS), Dec 9–12, 2025 in San Antonio, TX.

Presentations include subgroup analyses from the phase 3 VERITAC-2 trial versus fulvestrant, ctDNA biomarker analyses from a phase 1/2 study, real-world ESR1 mutation prevalence after 1L therapy, an I-SPY2 endocrine optimization pilot, and a phase 1/2 trial of PF-07248144 combined with vepdegestrant. Pfizer is a development collaborator and Quantum Leap sponsors I-SPY2 EOP. Full abstracts available via the SABCS online program.

Insights

Clinical development strategist

Arvinas/Pfizer will present multiple vepdegestrant data sets at SABCS, showing program progress but no disclosed outcomes yet.

These accepted abstracts cover a phase 3 subgroup analysis (VERITAC-2), phase 1/2 ctDNA biomarker work, real‑world ESR1 mutation prevalence, a neoadjuvant I‑SPY2 pilot, and a trial‑in‑progress combining a KAT6 inhibitor with vepdegestrant. The set spans early biomarker, registrational subgroup analysis, real‑world epidemiology, and combination safety/feasibility work, which together map a broad clinical development pathway for vepdegestrant (ARV‑471).

Key dependencies and risks hinge on the undisclosed nature of the results; no efficacy or safety outcomes appear in the text, so the market‑relevant impact depends on what the posters reveal. Watch the VERITAC‑2 subgroup analyses timing at December 12, 2025 and the ctDNA and I‑SPY2 presentations on December 10–12, 2025 for concrete efficacy, safety, or biomarker signals that would change the program’s profile.

NEW HAVEN, Conn., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that multiple abstracts on vepdegestrant (ARV-471) have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), taking place December 9–12, 2025 in San Antonio, Texas. Vepdegestrant is a novel investigational PROTAC estrogen receptor (ER) degrader which is being developed with Pfizer Inc. (NYSE: PFE) as a potential monotherapy for estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (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: Subgroup analyses of VERITAC-2: A phase 3 trial of vepdegestrant, a PROTAC estrogen receptor (ER) degrader, versus fulvestrant in ER-positive/ human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (aBC)
Presenting Author: Erika P. Hamilton
Presentation Number: PD10-03
Presentation Type: Poster Spotlight Presentation
Session: Poster Spotlight 10: Novel Combinations with Endocrine Therapy
Date: Friday, December 12, 2025
Session Time: 7:00–8:30 AM CT
Presentation Time: 7:36–7:39 AM CT

Title: Circulating tumor DNA (ctDNA) biomarker analyses of a phase 1/2 study evaluating vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in ER-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (aBC)
Presenting Author: Seth A. Wander
Presentation Number: PS2-07-24
Presentation Type: Poster Presentation
Session: Poster Session 2
Date: Wednesday, December 10, 2025
Session Time: 5:00–6:30 PM CT

Title: Real-world prevalence of ESR1 mutations (ESR1m) among patients with estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) after first-line (1L) treatment with endocrine therapy (ET) and/or a cyclin dependent kinase 4/6 inhibitor (CDK4/6i)
Presenting Author: David Chandiwana
Presentation Number: PS1-11-09
Presentation Type: Poster Presentation
Session: Poster Session 1
Date: Wednesday, December 10, 2025
Session Time: 12:30–2:00 PM CT

Title: I-SPY2 Endocrine Optimization Pilot (EOP): Neoadjuvant vepdegestrant monotherapy or in combination with letrozole or abemaciclib in molecularly selected patients with stage 2/3 HR+ HER2-negative breast cancer (BC)
Presenting Author: Jo Chien
Presentation Number: PD10-02
Presentation Type: Poster Spotlight Presentation
Session: Poster Spotlight 10: Novel Combinations with Endocrine Therapy
Date: Friday, December 12, 2025
Session Time: 7:00–8:30 AM CT
Presentation Time: 7:33–7:36 AM CT

The I-SPY2 EOP trial is sponsored by Quantum Leap.

Title: A phase 1/2 trial evaluating the safety, tolerability, and efficacy of the KAT6 inhibitor, PF-07248144, in combination with vepdegestrant in patients with ER+/HER2− locally advanced or metastatic breast cancer
Presenting Author: Fengting Yan
Presentation Number: PS5-09-30
Presentation Type: Poster Presentation (Trial in Progress Poster)
Session: Poster Session 5
Date: Friday, December 12, 2025
Session Time: 12:30–2:00 PM CT

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

About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROTAC estrogen receptor degrader. In the VERITAC-2 Phase 3 study, vepdegestrant demonstrated statistically significant and clinically meaningful improvement in progression free survival compared to fulvestrant in patients 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. The U.S. Food and Drug Administration (FDA) is reviewing the filed New Drug Application (NDA) for vepdegestrant. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026. Vepdegestrant has also been granted Fast Track designation by the FDA, underscoring the significant unmet need in this patient population and the potential for vepdegestrant to offer a meaningful new treatment option.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer share worldwide development costs, commercialization expenses, and profits.

*In September 2025, Arvinas and Pfizer announced their plan to jointly select a third party for the commercialization and potential further development of vepdegestrant.

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, Arvinas 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 ARV-102, targeting LRRK2 for neurodegenerative disorders; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; ARV-806, targeting KRAS G12D for mutated cancers, including pancreatic and colorectal cancers; and vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer. 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 estrogen receptor positive (“ER+”)/human epidermal growth factor receptor 2 negative (“HER2-”) advanced or metastatic breast cancer with estrogen receptor 1 mutations in the second line-plus setting; vepdegestrant potential as a monotherapy and as part of combination therapy for ER+/HER2- breast cancer; and Arvinas, Inc.’s (“Arvinas”) and Pfizer, Inc.’s (“Pfizer”) plan to jointly select a third party for the commercialization and potential further development of vepdegestrant. 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: 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 as a monotherapy; whether the VERITAC-2 clinical trial will meet the secondary endpoint for overall survival; whether Arvinas and Pfizer will successfully perform their respective obligations under the collaboration between Arvinas and Pfizer; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant; risks and uncertainties related to the potential selection of a third party for the commercialization and potential further development of vepdegestrant; uncertainties relating to regulatory applications and related approval timelines, including with respect to the New Drug Application for vepdegestrant; risks related to seeking U.S. Food and Drug Administration (“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 will Arvinas (ARVN) present about vepdegestrant at SABCS on December 12, 2025?

Arvinas will present VERITAC-2 subgroup analyses and an I-SPY2 endocrine optimization pilot on December 12, 2025 during Poster Spotlight 10.

Which ARV-471 (vepdegestrant) biomarker data will be shown at SABCS 2025 and when?

ctDNA biomarker analyses from a phase 1/2 study (ARV-471) will be presented as Poster PS2-07-24 on December 10, 2025 during Poster Session 2.

Does the SABCS program list collaborators for Arvinas' ARV-471 presentations?

Yes; Pfizer is named as a development collaborator for ARV-471 and Quantum Leap sponsors the I-SPY2 endocrine optimization pilot.

Will Arvinas present real-world data on ESR1 mutations at SABCS 2025?

Yes; a poster on real-world prevalence of ESR1 mutations after first-line endocrine or CDK4/6 inhibitor therapy is scheduled for December 10, 2025 in Poster Session 1.

How can investors access the full ARV-471 abstracts from SABCS 2025?

The full abstracts are available through the SABCS online program and via the conference abstract listings.