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- 10 abstracts, including two oral presentations, reinforce Astellas’
long-term commitment to advancing oncology care -
TOKYO, May 18, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced it will present new data across its oncology portfolio at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 29 – June 2 in Chicago, reinforcing Astellas’ sustained commitment to improving outcomes for people living with cancer. The data will provide further insight into the durable efficacy of established treatment approaches, their use in clinical practice, and ongoing areas of research and development.
Urothelial carcinoma
In urothelial cancer, a key highlight will be a 3.5-year follow-up oral presentation from the Phase 3 EV-302 study (also known as KEYNOTE-A39), evaluating enfortumab vedotin in combination with pembrolizumab in previously untreated locally advanced or metastatic disease. These data provide additional insight into the durability of outcomes with this treatment approach in advanced disease, an important consideration in clinical management.
Additional data from multiple studies exploring the use of this combination in earlier settings will be presented during the congress. Together, these findings contribute to a broader understanding of how this treatment approach may be applied across advanced disease settings, as well as across patient subgroups.
Prostate cancer
In advanced prostate cancer, additional analyses from established clinical programs in non-metastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) with high-risk biochemical recurrence (BCR) and hormone- (or castration-) sensitive prostate cancer (mHSPC or mCSPC), including EMBARK and ARCHES, will provide further insight into treatment outcomes in patients with varying clinical characteristics, supporting clinical decision-making in practice.
Women’s health
For the first time at ASCO, Astellas will present an update on HIGHLIGHT 1, a trial-in-progress investigating the safety and efficacy of fezolinetant for the treatment of moderate to severe vasomotor symptoms in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy.
Astellas Presentations at the 2026 ASCO Annual Meeting
Enfortumab vedotin
| Presentation Title | Lead Author | Presentation Details |
| Enfortumab vedotin plus pembrolizumab vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma: 3.5-year follow-up and response analyses from the phase 3 EV-302 study. | T. Powles | Type: Oral Presentation Abstract Number: 4507 Date: May 29, 2026, 2:45 PM-5:45 PM CDT |
| Health-related quality of life with neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab in participants with muscle-invasive bladder cancer who are cisplatin ineligible: Phase 3 KEYNOTE-905 study | P. O’Donnell | Type: Oral Presentation Abstract Number: 4510 Date: May 30, 2026, 8:00 AM-9:30 AM CDT |
| Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab in participants with cisplatin-ineligible muscle-invasive bladder cancer: An analysis of clinically relevant subgroups in KEYNOTE-905. | N. Adra | Type: Poster Presentation Abstract Number: 4613 Date: May 31, 2026, 9:00 AM-12:00 PM CDT |
| Exploratory subgroup outcomes in the phase 3 KEYNOTE-B15 study of neoadjuvant-adjuvant enfortumab vedotin plus pembrolizumab for participants with muscle-invasive bladder cancer eligible for cisplatin | C. Hoimes | Type: Poster Presentation Abstract Number: 4614 Date: May 31, 2026, 9:00 AM-12:00 PM CDT |
Enzalutamide
| Presentation Title | Lead Author | Presentation Details |
| Predictors of treatment duration in patients with metastatic hormone-sensitive prostate cancer treated with enzalutamide: a post hoc analysis of ARCHES | A. Armstrong | Type: Poster Presentation Abstract Number: 5093 Date: May 31, 2026, 9:00 AM-12:00 PM CDT |
| Efficacy and safety of enzalutamide in patients with metastatic hormone-sensitive prostate cancer and cardiometabolic comorbidities and/or related concomitant medications: ARCHES post hoc | A. Stenzl | Type: Poster Presentation Abstract Number: 5092 Date: May 31, 2026, 9:00 AM-12:00 PM CDT |
| EMBARK: Testosterone recovery to >250 ng/dL following treatment suspension | S. Freedland | Type: Poster Presentation Abstract Number: 5088 Date: May 31, 2026, 9:00 AM-12:00 PM CDT |
| Outcomes with androgen-deprivation therapy plus androgen (ADT) receptor pathway inhibitors (ARPIs) in veterans with de novo metastatic castration-sensitive prostate cancer who were elderly, frail, or had high comorbidity: a subgroup analysis of enzalutamide and high-volume disease | M. Schoen | Type: Poster Presentation Abstract Number: 5094 Date: May 31, 2026, 9:00 AM-12:00 PM CDT |
Fezolinetant
| Presentation Title | Lead Author | Presentation Details |
| HIGHLIGHT 1: A randomized, placebo-controlled, double-blind, phase 3 clinical study to investigate the efficacy and safety of fezolinetant for treatment of moderate to severe vasomotor symptoms (hot flashes) in women with stage 0 to 3 hormone receptor–positive breast cancer who are receiving adjuvant endocrine therapy | C. Bouchard | Type: Poster Presentation Abstract Number: TPS642 Date: June 1, 2026, 1:30 PM-4:30 PM CDT |
Pipeline
| Presentation Title | Lead Author | Presentation Details |
| Trial in progress: ASP2998, a trophoblast cell-surface antigen 2 (TROP2)–targeted immunostimulatory antibody-drug conjugate with dual payloads, in patients with locally advanced unresectable or metastatic solid tumors: A phase 1b/2 study. | G. Sonpavde | Type: Poster Presentation Abstract Number: TPS2665 Date: May 30, 2026, 1:30 PM-4:30 PM CDT |
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’ PADCEVTM (enfortumab vedotin) and Merck’s KEYTRUDA® (pembrolizumab) in patients with previously untreated metastatic urothelial cancer and in patients with muscle-invasive bladder cancer (MIBC). 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.
Contacts for inquiries or additional information:
Astellas Pharma Inc.
Corporate.Communications@us.astellas.com
+81-3-3244-3201
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