Arvinas Updates Guidance for First- and Second-Line Phase 3 Combination Trials with Vepdegestrant, Highlights Upcoming Milestones, and Provides Corporate Update
Arvinas (ARVN) announced key updates and milestones for 2025, focusing on its protein degradation drug pipeline. The company plans to initiate two Phase 3 combination trials for vepdegestrant in breast cancer treatment: a first-line trial combining with Pfizer's atirmociclib and a second-line trial with a CDK4/6 inhibitor, both starting in 2025.
Key upcoming milestones include: topline data from VERITAC-2 Phase 3 monotherapy trial in Q1 2025, initial data presentation from ARV-102 for Parkinson's disease, and preliminary results from ARV-393 Phase 1 trial in B-cell lymphomas. The company also plans to submit an IND for a PROTAC KRAS G12D degrader.
In corporate news, Alex Santini has been appointed interim Chief Commercial Officer, effective January 17, 2025, replacing John Northcott.
Arvinas (ARVN) ha annunciato aggiornamenti e tappe importanti per il 2025, concentrandosi sulla sua pipeline di farmaci per la degradazione delle proteine. L'azienda prevede di avviare due prove di combinazione di Fase 3 per il vepdegestrant nel trattamento del cancro al seno: una prova di prima linea in combinazione con l'atirmociclib di Pfizer e una prova di seconda linea con un inibitore CDK4/6, entrambe che inizieranno nel 2025.
Le tappe chiave in arrivo includono: dati preliminari dalla prova monoterapia VERITAC-2 di Fase 3 nel primo trimestre del 2025, presentazione iniziale dei dati da ARV-102 per il morbo di Parkinson e risultati preliminari dalla prova di Fase 1 di ARV-393 in linfomi a cellule B. L'azienda prevede anche di presentare una richiesta IND per un degradatore PROTAC KRAS G12D.
In notizie aziendali, Alex Santini è stato nominato Chief Commercial Officer ad interim, con decorrenza dal 17 gennaio 2025, sostituendo John Northcott.
Arvinas (ARVN) anunció actualizaciones clave y hitos para 2025, centrándose en su línea de medicamentos para la degradación de proteínas. La compañía planea iniciar dos pruebas de combinación de Fase 3 para vepdegestrant en el tratamiento del cáncer de mama: una prueba de primera línea combinada con atirmociclib de Pfizer y una prueba de segunda línea con un inhibidor de CDK4/6, comenzando ambas en 2025.
Los hitos clave que se avecinan incluyen: datos preliminares de la prueba de monoterapia VERITAC-2 de Fase 3 en el primer trimestre de 2025, presentación inicial de datos de ARV-102 para la enfermedad de Parkinson y resultados preliminares de la prueba de Fase 1 de ARV-393 en linfomas de células B. La compañía también planea presentar una solicitud IND para un degradador PROTAC KRAS G12D.
En noticias corporativas, Alex Santini ha sido nombrado Director Comercial interino, con efecto a partir del 17 de enero de 2025, reemplazando a John Northcott.
Arvinas (ARVN)는 단백질 분해 약물 파이프라인에 중점을 두고 2025년을 위한 주요 업데이트 및 이정표를 발표했습니다. 회사는 유방암 치료를 위한 vepdegestrant에 대해 두 개의 3상 조합 시험을 시작할 계획입니다: Pfizer의 atirmociclib과 결합하는 1차 시험과 CDK4/6 억제제와 함께하는 2차 시험으로, 두 시험 모두 2025년에 시작됩니다.
앞으로의 주요 이정표에는 2025년 1분기 VERITAC-2 3상 단독 요법 시험의 주요 데이터, 파킨슨병에 대한 ARV-102의 초기 데이터 발표, B세포 림프종에 대한 ARV-393 1상 시험의 예비 결과가 포함됩니다. 회사는 또한 PROTAC KRAS G12D 분해제에 대한 IND를 제출할 계획입니다.
기업 뉴스에 따르면, Alex Santini가 2025년 1월 17일부터 John Northcott를 대체하여 임시 최고 상업 책임자로 임명되었습니다.
Arvinas (ARVN) a annoncé des mises à jour clés et des jalons pour 2025, en se concentrant sur son pipeline de médicaments pour la dégradation des protéines. La société prévoit de lancer deux essais de combinaison de Phase 3 pour le vepdegestrant dans le traitement du cancer du sein : un essai de première ligne en combinaison avec l'atirmociclib de Pfizer et un essai de deuxième ligne avec un inhibiteur de CDK4/6, les deux débutant en 2025.
Les jalons clés à venir incluent : données préliminaires de l'essai monothérapeutique VERITAC-2 en Phase 3 au premier trimestre 2025, présentation initiale des données d'ARV-102 pour la maladie de Parkinson, et résultats préliminaires de l'essai de Phase 1 d'ARV-393 dans les lymphomes à cellules B. La société prévoit également de soumettre une demande IND pour un dégradant PROTAC KRAS G12D.
Dans les nouvelles d'entreprise, Alex Santini a été nommé directeur commercial par intérim, à compter du 17 janvier 2025, remplaçant John Northcott.
Arvinas (ARVN) hat wichtige Aktualisierungen und Meilensteine für 2025 angekündigt, wobei der Fokus auf seiner Arzneimittelpipeline zur Proteinabbau liegt. Das Unternehmen plant die Initiierung von zwei Phase-3-Kombinationsstudien für Vepdegestrant in der Behandlung von Brustkrebs: einer Erstlinienstudie in Kombination mit Pfizers Atirmociclib und einer Zweitlinienstudie mit einem CDK4/6-Inhibitor, die beide 2025 beginnen sollen.
Wichtige bevorstehende Meilensteine umfassen: Topline-Daten aus der VERITAC-2 Phase-3 Monotherapie-Studie im ersten Quartal 2025, die erste Datendarstellung von ARV-102 für Parkinson-Krankheit und vorläufige Ergebnisse aus der ARV-393 Phase-1-Studie bei B-Zell-Lymphomen. Das Unternehmen plant außerdem, eine IND für einen PROTAC KRAS G12D Degrader einzureichen.
In Unternehmensnachrichten wurde Alex Santini mit Wirkung zum 17. Januar 2025 als interimistischer Chief Commercial Officer ernannt, der John Northcott ersetzt.
- Multiple Phase 3 trials planned for 2025, expanding vepdegestrant's potential market reach
- Strategic partnership with Pfizer for combination trials
- Diversified pipeline with multiple clinical programs advancing (ARV-102, ARV-393)
- Planned IND submission for KRAS G12D degrader shows pipeline expansion
- Discontinuation of VERITAC-3 trial beyond study lead-in
- Change in commercial leadership could impact launch preparations
Insights
This strategic update reveals several critical pipeline developments for Arvinas's protein degradation platform. The most immediate catalyst is the upcoming VERITAC-2 Phase 3 trial results in Q1 2025 for vepdegestrant in breast cancer - a pivotal moment that could validate their PROTAC technology. The partnership with Pfizer for combination trials, particularly with novel CDK4 inhibitor atirmociclib, strengthens the commercial potential in the lucrative first-line setting.
The expansion into neurodegenerative diseases with ARV-102 for Parkinson's represents a strategic diversification beyond oncology. The planned IND for KRAS G12D degrader is particularly noteworthy, as KRAS has been a historically undruggable target with massive market potential.
The trial strategy demonstrates sophisticated clinical development planning. The shift to combine vepdegestrant with atirmociclib in first-line breast cancer, while discontinuing the palbociclib combination VERITAC-3 trial, suggests promising internal data supporting this decision. The dual approach of running parallel Phase 3 trials in first and second-line settings optimizes the potential market opportunity.
The advancement of ARV-102 into patient trials marks a significant technical achievement - successfully developing a brain-penetrant PROTAC molecule for CNS disorders is a major technical feat. The planned presentation at AD/PD conference could be a watershed moment for applying protein degradation technology to neurodegenerative diseases.
The commercial implications are substantial. The breast cancer market for ER+/HER2- represents a multi-billion dollar opportunity. Pfizer's involvement provides both validation and commercial muscle. The appointment of Alex Santini as interim CCO brings valuable market access expertise from Bayer and Lexicon, critical for navigating the complex reimbursement landscape for novel therapeutics.
The diversification into Parkinson's disease and KRAS targeting significantly expands the addressable market. Success in any of these programs could reshape Arvinas's market position from a clinical-stage biotech to a commercial entity with multiple revenue streams.
– Vepdegestrant to be combined with Pfizer’s novel investigational CDK4 inhibitor atirmociclib in a first-line Phase 3 trial planned to initiate in 2025; a second-line Phase 3 combination trial will combine vepdegestrant with a CDK4/6 inhibitor, also planned to initiate in 2025 –
– Topline data from the monotherapy Phase 3 VERITAC-2 trial of vepdegestrant anticipated in 1Q25 –
– The Company recently initiated a Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease –
– Data disclosures anticipated from multiple clinical and pre-clinical programs, including ARV-102 and ARV-393, and planned IND submission for a PROTAC KRAS G12D degrader in 2025 –
NEW HAVEN, Conn., Jan. 10, 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 updated guidance for the planned first- and second-line combination clinical trials for vepdegestrant in patients with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer, highlighted key upcoming milestones and provided a corporate update.
“We are on the cusp of a major transformation in 2025, with the potential to provide significant benefit to patients and meaningful value to our stockholders,” said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. “We are on track to report topline results from our first Phase 3 trial in the first quarter and to initiate two additional Phase 3 trials by the end of the year. In the first half of 2025, we plan to present the first-in-human data from ARV-102, our PROTAC LRRK2 degrader, which we believe will highlight the potential value that our PROTAC degraders may offer for patients with neurodegenerative diseases. And finally, we plan to share initial data from our Phase 1 trial with ARV-393, our PROTAC BCL6 degrader, which will provide an early look the tolerability and efficacy in patients with B-cell lymphomas.”
Select milestones anticipated in 2025
Vepdegestrant: Oral PROTAC ER degrader
As part of Arvinas’ global collaboration with Pfizer, in 2025 the companies plan to:
- Announce topline data for the VERITAC-2 Phase 3 monotherapy clinical trial in patients with second-line-plus ER+/HER2- metastatic breast cancer (mBC) (1Q25).
- Initiate two new Phase 3 combination trials in patients with ER+/HER2- mBC (pending emerging data and regulatory feedback):
- First-line Phase 3 combination trial with Pfizer’s novel investigational CDK4 inhibitor, atirmociclib.
- Second-line Phase 3 combination trial with a CDK4/6 inhibitor.
With the prioritization of the vepdegestrant plus atirmociclib combination for the first-line setting, the VERITAC-3 trial evaluating vepdegestrant plus palbociclib in the first-line will not proceed beyond the study lead-in.
ARV-102: Oral PROTAC LRRK2 degrader
- Present single-ascending dose data from the ongoing Phase 1 clinical trial in healthy volunteers in an oral session at the Alzheimer’s Disease/Parkinson’s Disease (AD/PD) conference in Vienna, Austria (April 1-4, 2025).
- Complete enrollment and present initial data from the ongoing Phase 1 clinical trial in patients with Parkinson’s disease.
ARV-393: Oral PROTAC BCL6 degrader
- Present initial data from the ongoing Phase 1 clinical trial in patients with B-cell lymphomas (NCT06393738).
Novel PROTAC KRAS G12D degrader
- File an Investigational New Drug (IND) application.
Corporate update
Alex Santini, Arvinas’ Senior Vice President, Global and U.S. Market Access, has been appointed interim Chief Commercial Officer, effective January 17, 2025. Mr. Santini joined Arvinas in 2023 with more than 30 years of experience managing and leading commercial organizations. Previously, he was Executive Vice President, Chief Commercial Officer, at Lexicon Pharmaceuticals. Prior to Lexicon, Mr. Santini was Executive Vice President, U.S. Market Access at Bayer, where he served on the U.S. Executive Committee. Mr. Santini’s prior experience also includes serving as Senior Vice President, Market Access at Nektar Therapeutics, and he began his career at Berlex Laboratories, where he served in roles of increasing responsibility in the commercial organization.
John Northcott, Chief Commercial Officer, is leaving the Company for personal reasons, effective January 17, 2025.
“Our commercial organization couldn’t be in a better position, and I look forward to working closely with Alex,” continued Dr. Houston. “He has been a highly valued member of the Arvinas team for multiple years, and his well-established ability to build and lead an outstanding commercial team will be invaluable as we prepare for our potential first launch alongside our partners at Pfizer. We thank John for his contributions to the business, particularly his efforts to begin building a strong commercial organization for launch.”
About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROTAC 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- locally 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; 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 the plans and expected timing of initiation of two Phase 3 vepdegestrant combination clinical trials, in the first- and second-line settings, pending emerging data and regulatory feedback; the expected timing to report topline data from the VERITAC-2 Phase 3 monotherapy clinical trial of vepdegestrant; the potential to provide significant benefit to patients and meaningful value to stockholders in 2025; the plans and timing of presentation of first-in-human data from ARV-102 and the company’s belief that such data will highlight the potential value that its PROTAC degraders may offer patients with neurodegenerative diseases; the plans and timing of sharing initial data from the company’s Phase 1 clinical trial of ARV-393; and the plans and expected timing of filing an investigational new drug application for a PROTAC KRAS G12D degrader. 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,” “might,” “plan,” “predict,” “project,” “target,” “goal,” “potential,” “will,” “would,” “could,” “should,” “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: Arvinas’ and Pfizer’s performance of the respective obligations with respect to Arvinas’ collaboration with Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant; whether Arvinas will be able to successfully conduct and complete development for its other product candidates, including whether Arvinas initiates and completes clinical trials for its product candidates and receives results from its clinical trials on its expected timelines or at all; Arvinas’ ability to protect its intellectual property portfolio; 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, 2023 and subsequent other reports, including its quarterly 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
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