Patient-Reported Outcomes from VERITAC-2 Clinical Trial Support Clinical Benefit of Vepdegestrant in Patients with ESR1-Mutated, ER+/HER2- Advanced or Metastatic Breast Cancer Previously Treated with Endocrine-Based Therapy
Arvinas (NASDAQ: ARVN) reported patient-reported outcomes from the Phase 3 VERITAC-2 trial showing vepdegestrant delayed deterioration in overall quality of life, pain, and multiple functioning domains versus fulvestrant in patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy.
The trial enrolled 624 patients (270 with ESR1 mutations) across 213 sites in 25 countries; progression-free survival showed a statistically significant improvement and overall survival remains the key secondary endpoint.
Arvinas (NASDAQ: ARVN) ha riportato i risultati riferiti dai pazienti dello studio di fase 3 VERITAC-2 che mostrano che la vepdegestrant ha ritardato il peggioramento della qualità della vita complessiva, del dolore e di molteplici domini di funzionamento rispetto al fulvestrant in pazienti con cancro al seno avanzato o metastatico ER+/HER2- con mutazione ESR1, precedentemente trattati con terapie ormonali basate sull'endocrinologia.
Lo studio ha arruolato 624 pazienti (270 con mutazioni ESR1) in 213 centri in 25 paesi; la sopravvivenza libera da progressione ha mostrato un miglioramento statisticamente significativo e la sopravvivenza globale resta l'endpoint secondario chiave.
Arvinas (NASDAQ: ARVN) informó resultados reportados por pacientes del ensayo de fase 3 VERITAC-2 que muestran que la vepdegestrant retrasa el deterioro en la calidad de vida global, el dolor y múltiples dominios de funcionamiento frente al fulvestrant en pacientes con cáncer de mama avanzado o metastásico ER+/HER2- con mutación ESR1, previamente tratados con terapia basada en endocrino.
El ensayo inscribió 624 pacientes (270 con mutaciones ESR1) en 213 sitios en 25 países; la supervivencia libre de progresión mostró una mejora estadísticamente significativa y la supervivencia global sigue siendo el criterio secundario clave.
Arvinas (NASDAQ: ARVN)는 3상 VERITAC-2 시험의 환자 보고 결과를 발표했고, vepdegestrant가 Fulvestrant에 비해 ESR1 돌연변이 ER+/HER2- 진행성 또는 전이성 유방암 환자에서 전반적 삶의 질, 통증 및 다수의 기능 영역의 악화를 지연시켰다고 제시했습니다. 이들 환자는 이전에 내분비 치료를 받았습니다.
시험은 213개 사이트에서 25개국에 걸쳐 624명의 환자를 등록했고(그중 ESR1 돌연변이 270명), 무진행 생존기간은 통계적으로 유의한 개선을 보였으며 전체 생존은 여전히 주요 이차 종점으로 남아 있습니다.
Arvinas (NYSE: ARVN) a communiqué les résultats rapportés par les patients de l'essai de phase 3 VERITAC-2 montrant que le vepdegestrant retarde le déclin de la qualité de vie globale, la douleur et plusieurs domaines de fonctionnement par rapport au fulvestrant chez des patientes atteintes d'un cancer du sein avancé ou métastatique ER+/HER2- avec mutation ESR1, préalablement traitées par une thérapie endocrinienne.
L'essai a recruté 624 patientes (270 avec mutations ESR1) dans 213 sites dans 25 pays; la survie sans progression a montré une amélioration statistiquement significative et la survie globale demeure le critère secondaire clé.
Arvinas (NASDAQ: ARVN) berichtete über patientenberichtete Ergebnisse aus der Phase-3-VERITAC-2-Studie, die zeigen, dass Vepdegestrant eine Verschlechterung der Gesamtlebensqualität, Schmerzen und mehrerer Funktionsbereiche gegenüber Fulvestrant verzögert bei Patientinnen mit ESR1-mutiertem ER+/HER2- fortgeschrittenem oder metastatischem Brustkrebs, die zuvor eine endokrine Therapie erhalten hatten.
Die Studie rekrutierte 624 Patienten (270 mit ESR1-Mutationen) an 213 Standorten in 25 Ländern; das progressionsfreie Überleben zeigte eine statistisch signifikante Verbesserung und das Gesamtüberleben bleibt der entscheidende sekundäre Endpunkt.
Arvinas (بورصة ناسداك: ARVN) أبلغت عن نتائج مُبلغ عنها من المرضى من تجربة المرحلة 3 VERITAC-2 التي أظهرت أن فبديجسترانت (vepdegestrant) أخرّ تدهور الجودة الشاملة للحياة، الألم، والعديد من مجالات الأداء مقارنةً بالفولڤسترنت Fulvestrant لدى مرضى سرطان الثدي المتقدم أو الانتشاري ER+/HER2- مع طفرة ESR1، الذين تلقوا علاجاً هرمونياً سابقاً.
اشتمل التجربة على 624 مريضاً (270 منهم بطفرات ESR1) عبر 213 موقعاً في 25 دولة؛ أظهر البقاء خالٍ من التقدم تحسناً ذا دلالة إحصائية ولا يزال البقاء الكلي على قيد الحياة هو نقطة النهاية الثانوية الرئيسية.
Arvinas (NASDAQ: ARVN) 公布了来自 III 期 VERITAC-2 研究的患者自述结果，显示相较于 fulvestrant，vepdegestrant 在 ESR1 突变的 ER+/HER2- 晚期或转移性乳腺癌患者中显著延缓了总体生活质量、疼痛及多项功能领域的恶化，且患者此前接受过内分泌治疗。
该试验共纳入 624 名患者（其中 270 名为 ESR1 突变者），覆盖 213 个站点、25 个国家；无进展生存期显示具有统计学意义的改善，总体生存仍然是关键的次级终点。
- VERITAC-2 enrolled 624 patients
- 270 patients (43%) had ESR1-mutated disease
- Vepdegestrant showed statistically significant PFS improvement
- PROs: delayed deterioration in overall QoL and pain
- Overall survival results not yet reported
- ESR1-mutated subgroup size is 270 patients
Insights
Phase 3 VERITAC-2 reports statistically significant PRO and PFS benefits for vepdegestrant versus fulvestrant in ESR1‑mutated ER+/HER2‑ advanced breast cancer.
In a randomized global trial enrolling 624 patients (270 with ESR1 mutations) across 213 sites in 25 countries, vepdegestrant showed statistically significant delays in deterioration for overall health status, pain, and multiple functioning domains compared with fulvestrant, and the release notes a statistically significant improvement in progression‑free survival in the second‑line setting. The PRO results indicate that patients on vepdegestrant maintained quality of life and daily functioning longer while on treatment.
Key dependencies and risks include confirmation of the reported statistical significance across prespecified PRO domains and alignment with the previously reported efficacy and safety data; overall survival remains the key secondary endpoint. Watch for formal presentation details from ESMO on
– Data demonstrated that vepdegestrant maintained patients’ quality of life for statistically significantly longer and delayed worsening of overall health, daily functioning, and symptoms, including pain, compared to fulvestrant –
NEW HAVEN, Conn., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced new patient-reported outcomes (PRO) data from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant, which are being presented in a mini oral session at the 2025 European Society for Medical Oncology (ESMO) Congress. Vepdegestrant is a novel investigational PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader which is being developed with Pfizer Inc. (NYSE: PFE) as a potential monotherapy for estrogen receptor 1 (ESR1) mutated, estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine-based therapy.
In the VERITAC-2 clinical trial, patients with ESR1-mutated disease treated with vepdegestrant reported a statistically significant delay in deterioration of overall quality of life, pain, and multiple functioning domains compared to those who received fulvestrant. These findings complement previously reported clinical efficacy and safety data from the VERITAC-2 clinical trial, reinforcing vepdegestrant as a potential treatment option for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy.
“These new data highlight the potential of vepdegestrant to provide significant improvements across important measures for patients with ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in the second-line setting,” said John Houston, Ph.D., Chairperson, President and Chief Executive Officer of Arvinas. “In addition to a statistically significant improvement in progression-free survival, patients receiving vepdegestrant had statistically significant and clinically meaningful benefits in patient-reported outcomes as compared to fulvestrant while being treated for their cancer. These data from the VERITAC-2 clinical trial reflect Arvinas’ goal of striving to pair scientific innovation with improved patient outcomes.”
In patients with ESR1-mutated disease, vepdegestrant demonstrated a reduced risk of deterioration compared to fulvestrant which was statistically significant in several PRO domains including overall health status, pain severity, and functioning (including role, cognitive, emotional, and social functioning), and vepdegestrant consistently showed reduced risk of deterioration versus fulvestrant across all PRO domains.
We believe these data support vepdegestrant’s opportunity to be a potential best-in-class therapy for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine therapy.
Also presented at ESMO 2025 were results from the TACTIVE-N Phase 2 clinical trial (NCT05549505), which evaluated neoadjuvant vepdegestrant in postmenopausal women with ER+/HER2– localized breast cancer. The results presented showed that neoadjuvant vepdegestrant demonstrated biological and clinical activity in this treatment-naïve, predominantly ESR1 wild-type population of postmenopausal women with ER+/HER2- localized breast cancer.
Additional detail on Arvinas and Pfizer’s presentations at ESMO 2025:
| 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: 489 MO | |
| Presentation Type: Mini oral session | |
| Session: Breast cancer, metastatic | |
| Date: October 20, 2025 | |
| Time: 11:25-11:30 AM 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: 10:45-10:50 AM CEST | |
About the VERITAC-2 Clinical Trial
The Phase 3 VERITAC-2 clinical trial (NCT05654623) is a global, randomized trial evaluating the efficacy and safety of vepdegestrant (ARV-471) as a monotherapy compared to fulvestrant in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with a CDK4/6 inhibitor plus endocrine therapy. The trial enrolled 624 patients, 270 of whom had ESR1m positive disease, at 213 sites in 25 countries.
Patients were randomized 1:1 to receive either vepdegestrant once daily, orally on a 28-day continuous dosing schedule, or fulvestrant, administered intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each 28-day cycle starting from Day 1 of Cycle 2. In the trial,
About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) estrogen receptor degrader. Vepdegestrant is being developed 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.
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. 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 ER+/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, underscoring the significant unmet need in this patient population and the potential for vepdegestrant to offer a meaningful new treatment option.
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 to provide significant improvements across important measures for patients with ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in the second-line setting; vepdegestrant’s potential as a monotherapy and best-in-class treatment option for patients with, ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine therapy; and Arvinas’ goal of striving to pair scientific innovation with improved patient outcomes. 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 our 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 and other product candidates on current timelines or at all; risks and uncertainties related to the potential out-license of vepdegestrant to a third party; 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 did Arvinas announce about vepdegestrant (ARVN) on October 20, 2025?
How many patients were enrolled in the VERITAC-2 trial (ARVN) and how many had ESR1 mutations?
What patient-reported outcomes did vepdegestrant (ARVN) improve versus fulvestrant?
Did VERITAC-2 (ARVN) show progression-free survival benefit for vepdegestrant?
Are overall survival results from VERITAC-2 (ARVN) available?
Where and when were the VERITAC-2 PRO data for vepdegestrant (ARVN) presented?
