| - 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 - TOKYO, Oct. 1, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will present ten abstracts from our portfolio and advancing pipeline at the European Society for Medical Oncology (ESMO) congress taking place from 17-21 October 2025, including new data for PADCEV™ (enfortumab vedotin) plus pembrolizumab in muscle-invasive bladder cancer (MIBC) which will be presented in an ESMO Presidential Symposium on 18 October. In prostate cancer, we are sharing final best-in-class overall survival data for XTANDI™ (enzalutamide) in high-risk, biochemically recurrent non-metastatic hormone sensitive disease, plus encouraging data for our next-generation bispecific T cell engager ASP2138 in solid tumors, demonstrating continued leadership in CLDN18.2-targeted precision medicine. 
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,
16:52 - 17:04 CEST | 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,
12:00-12:45 CEST | 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,
17:38-17:43 CEST | 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,
12:00-12:45 CEST | Real-world use of enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer previously treated with chemotherapy and immunotherapy in France | 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,
10:55-11:05 CEST | 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,
12:00-12:45 CEST |
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,
12:00-12:45 CEST | 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,
12:00-12:45 CEST | 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,
12:00-12:45 CEST |
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., Rahway, NJ, USA (known as MSD outside of the United States and Canada). 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 the United States, while Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing the product outside the United States. Pfizer receives alliance revenues as a share of U.S. profits and receives royalties on sales outside the U.S. 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.  View original content to download multimedia:https://www.prnewswire.com/news-releases/astellas-to-present-pioneering-advances-across-its-portfolio-and-pipeline-at-esmo-2025-302571874.html
SOURCE Astellas Pharma Inc. | |
