Astellas To Present Pioneering Advances Across Its Portfolio and Pipeline at ESMO 2025
Astellas Pharma will present ten abstracts at the European Society for Medical Oncology (ESMO) congress from October 17-21, 2025. The presentations include significant data from their oncology portfolio, highlighted by the EV-303 trial (KEYNOTE-905) results in muscle-invasive bladder cancer, which earned a prestigious Presidential Symposium slot.
Key presentations include final survival data for XTANDI in non-metastatic hormone-sensitive prostate cancer, long-term follow-up data from EV-302 examining enfortumab vedotin with pembrolizumab in urothelial cancer, and first clinical data for their investigational CLDN18.2-targeted bispecific T cell engager ASP2138 in solid tumors.
Astellas Pharma presenterà dieci abstract al Congresso della European Society for Medical Oncology (ESMO) dal 17 al 21 ottobre 2025. Le presentazioni includono dati significativi dal loro portafoglio oncologico, tra cui i risultati del trial EV-303 (KEYNOTE-905) nel cancro della vescica muscolo-invasivo, che hanno guadagnato una prestigiosa sessione Presidential Symposium.
Tra i principali interventi figurano i dati finali sulla sopravvivenza per XTANDI nel cancro della prostata non metastatico ormono-sensibile, i dati di follow-up a lungo termine di EV-302 che esaminano enfortumab vedotin con pembrolizumab nel cancro urotheliale, e i primi dati clinici del loro investigational ASP2138, un bispecific T cell engager mirato a CLDN18.2 nei tumori solidi.
Astellas Pharma presentará diez resúmenes en el congreso de la European Society for Medical Oncology (ESMO) del 17 al 21 de octubre de 2025. Las presentaciones incluyen datos significativos de su cartera oncológica, destacando los resultados del ensayo EV-303 (KEYNOTE-905) en cáncer de vejiga músculo- invasivo, que obtuvieron una plaza prestigiosa en la sesión Presidential Symposium.
Entre las presentaciones clave se encuentran los datos finales de supervivencia para XTANDI en cáncer de próstata no metastásico hormono-sensible, los datos de seguimiento a largo plazo de EV-302 que examinan enfortumab vedotin con pembrolizumab en cáncer uro- genito-urinaro, y los primeros datos clínicos de su investigacional ASP2138, un engager de células T bispecífico dirigido a CLDN18.2 en tumores sólidos.
Astellas Pharma는 2025년 10월 17일부터 21일까지 열리는 유럽 의학 종양학회(ESMO) 학회에서 10개의 초록을 발표합니다. 발표에는 종양학 포트폴리오의 중요한 데이터가 포함되며, 근육침투성 방광암에서의 EV-303 연구(KEYNOTE-905) 결과가 Presidential Symposium 구좌를 차지했습니다.
주요 발표로는 비전이성 호르몬감수성 전립선암에서 XTANDI의 최종 생존 데이터, 방광암에서 엔포르투눔 베도틴과 펨브롤리주맙을 조사하는 EV-302의 장기 추적 데이터, 그리고 고형 종양에서 표적 CLDN18.2의 이중 특이적 T세포 엔게저 ASP2138의 첫 임상 데이터가 있습니다.
Astellas Pharma présentera dix résumés au congrès de la European Society for Medical Oncology (ESMO) du 17 au 21 octobre 2025. Les présentations incluent des données significatives issues de leur portefeuille oncologique, mises en avant par les résultats de l’essai EV-303 (KEYNOTE-905) dans le cancer de la vessie musculo-invasif, qui ont mérité une place prestigieuse au sein de la session Presidential Symposium.
Les présentations clés comprennent les données finales de survie pour XTANDI dans le cancer de la prostate non métastatique hormono-sensible, les données de suivi à long terme d’EV-302 évaluant l’enfortumab vedotin avec pembrolizumab dans le cancer urothélial, et les premiers données cliniques de leur candidat investigateur ASP2138, un bispecific T cell engager ciblant CLDN18.2 dans les tumeurs solides.
Astellas Pharma wird auf dem ESMO-Kongress der European Society for Medical Oncology vom 17. bis 21. Oktober 2025 zehn Abstracts präsentieren. Die Präsentationen enthalten signifikante Daten aus dem Onkologie-Portfolio, hervorgehoben durch die EV-303-Studie (KEYNOTE-905) beim muskelinvasiven Blasenkarzinom, die eine prestigeträchtige Platzierung im Presidential Symposium erhielten.
Zu den wichtigsten Präsentationen gehören die endgültigen Überlebensdaten für XTANDI beim nicht-metastasierten hormonensensitiven Prostatakrebs, die Langzeit-Follow-up-Daten von EV-302, die Enfortumab Vedotin mit Pembrolizumab beim Urothelkarzinom untersuchen, und die ersten klinischen Daten für ihren investigativen ASP2138, einen bispezifischen T-Zell-Engager, der auf CLDN18.2 abzielt, in soliden Tumoren.
Astellas Pharma ستقدّم عشرة ملخصات في مؤتمر الجمعية الأوروبية للأورام الطبية (ESMO) من 17 إلى 21 أكتوبر 2025. تتضمن العروض بيانات مهمة من محفظتها في مجال الأورام، مع إبراز نتائج تجربة EV-303 (KEYNOTE-905) في سرطان المثانة العضلي الغزير، والتي حازت على مكانة متميزة في جلسة Presidential Symposium.
تشمل العروض الرئيسية بيانات البقاء على قيد الحياة النهائية لـ XTANDI في سرطان البروستاتا غير المتقدم المعتمد هرمونياً، وبيانات المتابعة الطويلة الأجل لـ EV-302 التي تفحص enfortumab vedotin مع pembrolizumab في سرطان المسالك البولية، وأول بيانات سريرية لـ ASP2138، وهو موجّه مزدوج الخلايا T يستهدف CLDN18.2 في الأورام الصلبة.
Astellas Pharma 将在 欧洲肿瘤学会（ESMO）大会 于 2025 年 10 月 17-21 日举行期间，发表十篇摘要。此次演讲包含其肿瘤学组合中的重要数据，重点介绍肌层浸润性膀胱癌中 EV-303 研究（KEYNOTE-905）的结果，该结果在总统研讨会中获得了崇高的席位。
主要演讲包括 XTANDI 在非转移性激素敏感性前列腺癌中的最终生存数据、EV-302 的长期随访数据，该研究评估 enfortumab vedotin 联合 pembrolizumab 在尿路上皮癌中的治疗，以及他们的研究性药物 ASP2138——一个针对 CLDN18.2 的双特异性 T 细胞激活剂在实体瘤中的首批临床数据。
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- New clinical data across ten accepted abstracts demonstrate significant progress across Astellas' innovative oncology programs -
- Results from the EV-303 trial (also known as KEYNOTE-905) in cisplatin-ineligible patients with muscle invasive bladder cancer selected for presentation in an ESMO Presidential Symposium -
Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas
"Astellas focuses on some of the most complex and devastating cancers. These ESMO data demonstrate our 'bench to bedside' approach in action – from deep disease biology to measurable improvements in patient outcomes. We're proud to share breakthrough new survival data in muscle-invasive bladder cancer and overall survival data in hormone sensitive prostate cancer, which reflect potentially practice-changing advances that could transform outcomes for patients who need them most. We also continue to advance innovation in gastric and gastroesophageal junction cancer with new clinical data for our next-generation investigational bispecific T cell engager."
Highlights from Astellas at ESMO 2025 will include:
- Data from the Phase 3 EV-303 (also known as KEYNOTE-905) clinical trial which will be featured in an ESMO Presidential Symposium, evaluating enfortumab vedotin in combination with pembrolizumab as neoadjuvant and adjuvant treatment (before and after surgery) versus surgery alone, the current standard of care, in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy.
- Long-term follow-up data from the EV-302 clinical trial exploring the utility of enfortumab vedotin in combination with pembrolizumab for patients with challenging baseline characteristics, including older patients with locally advanced or metastatic urothelial cancer and those with comorbidities such as diabetes and chronic kidney disease.
- Final data from the Phase 3 EMBARK trial assessing overall survival with enzalutamide in combination with leuprolide and as monotherapy in patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence.
- First clinical data from Astellas' investigational CLDN18.2-targeted, next-generation bispecific CD3 T cell engager ASP2138, both as a monotherapy and in combination with standard of care therapy.
Astellas Presentations at ESMO Congress 2025
Enfortumab vedotin
|
Presentation Title |
Presenter |
Presentation Details |
|
Perioperative enfortumab vedotin plus pembrolizumab in participants with muscle-invasive bladder cancer who are cisplatin-ineligible: The phase 3 KEYNOTE-905 study |
C. Vulsteke |
Type: Presidential Symposium 1 Abstract Number: LBA2
Date: October 18, |
|
Enfortumab vedotin and pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer: An exploratory analysis in older patients and those with comorbidities from EV-302 |
N. Mar |
Type: Poster Abstract Number: 3073P
Date: October 18, |
|
Enfortumab vedotin plus pembrolizumab as first-line treatment in recurrent or metastatic head and neck squamous cell carcinoma: Results from a cohort of the EV-202 trial |
P.L. Swiecicki |
Type: Mini oral Abstract Number: 1329 MO
Date: October 19, |
|
EV-103 Cohort K: Efficacy and safety of enfortumab vedotin with or without pembrolizumab in cisplatin-ineligible pts with previously untreated locally advanced or metastatic urothelial cancer with a median follow-up of ≈3.5 y |
T.W. Friedlander |
Type: Poster Abstract Number: 3074P
Date: October 18, |
|
Real-world use of enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer previously treated with chemotherapy and immunotherapy in |
A. Fléchon |
Type: ePoster Abstract Number: 3111eP Date: October 18, 12:00-12:45 CEST |
Enzalutamide
|
Presentation Title |
Presenter |
Presentation Details |
|
Overall survival in EMBARK, a phase 3 randomised trial of enzalutamide or placebo plus leuprolide and enzalutamide monotherapy in patients with nonmetastatic hormone-sensitive prostate cancer with biochemical recurrence at high risk for metastasis |
S.J. Freedland |
Type: Proffered Paper Abstract Number: LBA87
Date: October 19, |
|
Baseline features and metastasis-free survival by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer: EMBARK post hoc analysis |
N.D. Shore |
Type: Poster Abstract Number: 2461P
Date: October 18, |
Pipeline
|
Presentation Title |
Presenter |
Presentation Details |
|
ASP2138 monotherapy in patients with (CLDN18.2)+, advanced solid tumors: Phase 1/1b trial |
K. Shitara |
Type: Poster Abstract Number: 2137P
Date: October 19, |
|
ASP2138 monotherapy or in combination with pembrolizumab and mFOLFOX6 or with ramucirumab and paclitaxel in (CLDN18.2)+ locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: Phase 1/1b trial |
F. Dayyani |
Type: Poster Abstract Number: 2136P
Date: October 19, |
|
Phase 1 trial of ASP5541 (PRL-02), a long-acting intramuscular depot injection of abiraterone decanoate, in patients with advanced prostate cancer |
J. Avitia |
Type: Poster Abstract Number: 2443P
Date: October 18, |
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.
About the Pfizer, Astellas and Merck Collaboration
Seagen and Astellas previously entered a clinical collaboration agreement with Merck to evaluate the combination of Seagen's and Astellas' PADCEV™ (enfortumab vedotin) and Merck's KEYTRUDA™ (pembrolizumab) in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
About XTANDI and the Pfizer/Astellas Collaboration
In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a commercial agreement to jointly develop and commercialize XTANDI® (enzalutamide) in
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
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SOURCE Astellas Pharma Inc.
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