Vepdegestrant

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. HamiltonPresentation Number: PD10-03Presentation Type: Poster Spotlight PresentationSession: Poster Spotlight 10: Novel Combinations with Endocrine TherapyDate: Friday, December 12, 2025Session Time: 7:00–8:30 AM CTPresentation 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. WanderPresentation Number: PS2-07-24Presentation Type: Poster PresentationSession: Poster Session 2Date: Wednesday, December 10, 2025Session 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 ChandiwanaPresentation Number: PS1-11-09Presentation Type: Poster PresentationSession: Poster Session 1Date: Wednesday, December 10, 2025Session 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 ChienPresentation Number: PD10-02Presentation Type: Poster Spotlight PresentationSession: Poster Spotlight 10: Novel Combinations with Endocrine TherapyDate: Friday, December 12, 2025Session Time: 7:00–8:30 AM CTPresentation 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 cancerPresenting Author: Fengting YanPresentation Number: PS5-09-30Presentation Type: Poster Presentation (Trial in Progress Poster)Session: Poster Session 5Date: Friday, December 12, 2025Session Time: 12:30–2:00 PM CT The full abstracts can be accessed via the SABCS online program. About VepdegestrantVepdegestrant 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 ArvinasArvinas (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 StatementsThis 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) 247-5089Jeff.Boyle@arvinas.com Media:Kirsten Owens+1 (203) 584-0307Kirsten.owens@arvinas.com

Roche said Tuesday that yet another late-stage study of giredestrant hit its efficacy mark at a pre-planned interim analysis, marking the first time a selective oestrogen receptor degrader (SERD) has demonstrated significant benefit in the adjuvant setting for patients with early-stage, oestrogen receptor (ER)-positive, HER2-negative breast cancer.The Phase III lidERA trial enrolled over 4100 patients with medium- or high-risk stage I-III disease. Participants were randomised to receive adjuvant giredestrant or standard-of-care endocrine therapy, the primary endpoint being invasive disease-free survival (DFS) excluding second primary non-breast cancers.Top-line findings showed the trial’s main goal was met, with giredestrant showing statistically significant, clinically meaningful invasive DFS benefit over endocrine therapy at the interim analysis. Roche noted that while the overall survival data were immature at the time, a clear positive trend was observed.Emphasising the fact that ER-positive patients account for up to 70% of breast cancer cases and a high rate of recurrence on or after adjuvant endocrine therapy, Levi Garraway, Roche's chief medical officer, said the “results underscore the potential of giredestrant as a new endocrine therapy of choice for people with early-stage breast cancer, where there is a chance for cure."Safety-wise, giredestrant was well tolerated, with adverse events consistent with its known profile and no unexpected findings. Detailed data will be presented at an upcoming medical conference and also shared with regulatory agencies.Gaining momentumThis lidERA results represent the second positive Phase III readout for the oral SERD, following the pivotal evERA data in advanced disease unveiled at this year’s European Society for Medical Oncology (ESMO) congress. The latest findings are further bolstered by prior neoadjuvant findings from the mid-stage coopERA trial, which demonstrated giredestrant's superiority over aromatase inhibitors in lowering Ki67 levels.Beyond evERA and lidERA, the Roche drug is in three other late-stage trials: with Pfizer’s Ibrance (palbociclib) in endocrine-sensitive recurrent advanced disease in persevERA, due to read out next year; with a CDK4/6 inhibitor in endocrine-resistant advanced disease; and with Phesgo (pertuzumab/trastuzumab/hyaluronidase) in ER+/HER2+ advanced breast cancer.However, competition for giredestrant is intensifying, with Lilly’s imlunestrant, alone or with Verzenio (abemaciclib) clearing the Phase III EMBER-3 trial, while AstraZeneca’s camizestrant — being explored in SERENA-4 and SERENA-6 studies — is projected to reach $6 billion in peak sales. Meanwhile, Pfizer and Arvinas’ PROTAC SERD vepdegestrant is under FDA review even as the partners seek to out-license it.Despite oncology not being a major long-term growth driver for Roche, it remains committed to key breast and lung cancer assets — including giredestrant, which it expects to be a CHF 3 billion-plus opportunity. (see – Vital Signs: Roche's shift from 'minor' disease settings to the big leagues).