- PADCEV™ (enfortumab vedotin) plus pembrolizumab data highlight durable survival benefit in advanced bladder cancer -
- VYLOY™ (zolbetuximab) research reinforces the role of CLDN18.2 in shaping gastric cancer treatment decisions -
TOKYO, Oct. 6, 2026 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that 21 abstracts from its oncology portfolio will be presented at the European Society for Medical Oncology Congress 2026 (ESMO 2026), taking place October 23-27 in Madrid, Spain. The presentations span prostate, urothelial, gastric/gastroesophageal junction (GEJ), lung and pancreatic cancers, reflecting Astellas' commitment to advancing standards of care and pursuing new scientific approaches designed for cancers where significant unmet need remains.
Moitreyee Chatterjee-Kishore, Ph.D., MBA, Executive Vice President and Head of Oncology Development, Astellas:
"Standards of care do not change by accident. The data being presented at ESMO 2026 demonstrate how a deep understanding of disease biology and differentiated modalities is helping advance care for patients with bladder, gastric, and prostate cancers, including through approaches such as PADCEV™ (enfortumab vedotin) plus pembrolizumab, VYLOY™ (zolbetuximab), and XTANDI™ (enzalutamide). We are building upon this knowledge to develop the next generation of therapeutic options for cancers where unmet needs remain and look forward to engaging in discussions about this work at the congress."
Highlights from Astellas' ESMO 2026 presentations include:
- Enfortumab vedotin plus pembrolizumab presentations include the longest follow-up reported to date in locally advanced or metastatic urothelial cancer, along with analyses across patient subgroups and treatment settings. Additional presentations include trials in progress exploring bladder preservation in muscle-invasive bladder cancer.
- Zolbetuximab presentations examine CLDN18.2 assessment, patient identification and real-world use, reinforcing the growing body of evidence supporting CLDN18.2-guided treatment decisions in gastric and GEJ cancers.
- Pipeline presentations feature trials-in-progress across Astellas' investigational programs, including Phase 3 trials of setidegrasib in KRAS G12D-mutated pancreatic and non-small cell lung cancers, a Phase 1 trial of ASP5834 in KRAS-mutated or amplified solid tumors, and a Phase 1b/2 trial of ASP546C in CLDN18.2-expressing solid tumors. Together, these investigational studies illustrate Astellas' continued investment in advancing new approaches aimed at overcoming challenges that have limited progress in hard-to-treat cancers.
Additional details on Astellas' presentations at ESMO 2026 are included below.
Presentation Title Lead Author Presentation Details
Enfortumab vedotin
EV-103 DE/Cohort A and Cohort K Final J. P. Maroto Rey Type: Rapid oral
Analysis: Enfortumab vedotin with or Abstract number: 4740RO
without pembrolizumab as first-line Date/time: Saturday,
October 24,
treatment for cisplatin (cis)-ineligible locally 10:15-11:45
advanced or metastatic urothelial
carcinoma: long-term follow-up analysis
from EV-103 cohorts DE/A and K
EV-302 Comorbidities (DCO3): S. S. Sridhar Type: Poster
Enfortumab vedotin plus pembrolizumab for Abstract number: 4761P
previously untreated locally advanced or Date/time: Friday, October
23,
metastatic urothelial carcinoma: updated 15:15-16:00
exploratory analysis of EV-302 in older
patients and those with comorbidities
EV-302 Clinical Subgroups (DCO3):
J. Bedke Type: Poster
Enfortumab vedotin + pembrolizumab in Abstract number: 4760P
previously untreated locally advanced or Date/time: Friday, October
23,
metastatic urothelial cancer: exploratory 15:15-16:00
analyses based on disease-related
characteristics from EV-302
EVOLVE 3: Real-world treatment patterns
F. Joly Type: ePoster
in patients with locally advanced and
metastatic urothelial cancer in France
EV-303/KN-905 ITT3: Perioperative
A. Ullén Type: Proffered paper
session
pembrolizumab or enfortumab vedotin plus Abstract number: 4733O
pembro in participants with muscle-invasive Date/time: Friday, October
23,
bladder cancer who are cisplatin-ineligible: 13:30-15:00
ad hoc analysis from KEYNOTE-905
EV-304/KN-B15 ctDNA: ctDNA analysis of J. Chatzkel Type: Proffered paper
session
the phase 3 KEYNOTE-B15 trial: Abstract number: 4734O
neoadjuvant and adjuvant enfortumab Date/time: Friday, October
23,
vedotin + pembrolizumab for participants 13:30-15:00
with muscle-invasive bladder cancer who
are eligible for cisplatin
EV-304/KN-B15 ePRO: Health-related A. Gómez De Liaño Type: Rapid oral
quality of life with neoadjuvant and adjuvant Abstract number: 4738RO
enfortumab vedotin plus pembrolizumab in Date/time: Saturday,
October 24,
participants (pts) with muscle-invasive 10:15-11:45
bladder cancer eligible for cisplatin in the
phase 3 KEYNOTE-B15 study
EV-209 TiP: EV-209: an open-label, single-arm, Thomas Powles Type: Poster
phase 2 study of enfortumab vedotin plus Abstract number: 4769TiP
pembrolizumab for bladder preservation in Date/time: Friday, October
23,
patients with muscle-invasive bladder cancer 15:15-16:00
eligible for radical cystectomy
EV-309 TiP: EV-309: an open-label, Matthew D. Galsky Type: Poster
randomized, phase 3 study of enfortumab Abstract number: 4770TiP
vedotin plus pembrolizumab for bladder Date/time: Friday, October
23,
preservation in patients with muscle-invasive 15:15-16:00
bladder cancer
Enzalutamide
Adelpi REALIZE: High-risk biochemically A. Merseburger Type: ePoster
recurrent (hrBCR) hormone sensitive Abstract number: 2063eP
prostate cancer (PC): European real-world Date/time: N/A
(RW) evidence on risk stratification, PSMA
PET use, and physician practices
AMNOG NMA in mHSPC: Network meta-analysis C. Ohlmann Type: Poster
(NMA) on the safety of androgen receptor pathway Abstract number: 2295P
inhibitors (ARPIs) in patients with metastatic Date/time: Friday, October
23,
hormone-sensitive prostate cancer (mHSPC) from 15:15-16:00
German AMNOG dossiers
CASPER: Outcomes of enzalutamide B. Shayegan Type: ePoster
(ENZ) and apalutamide (APA) in metastatic Abstract number: 2329eP
hormone-sensitive prostate cancer Date/time: N/A
(mHSPC): a Canadian real-world (RW) study
ARCHES/ARANOTE indirect safety S. Shariat Type: Poster
comparison: Indirect safety comparison of Abstract number: 2294P
enzalutamide (ENZA) and darolutamide Date/time: Friday, October
23,
(DARO) with androgen-deprivation therapy 15:15-16:00
(ADT) in metastatic hormone-sensitive
prostate cancer (mHSPC)
EMBARK deep PSA response: Deep S. Freedland Type: Poster
prostate-specific antigen (PSA) response Abstract number: 2293P
by prior definitive treatment (tx) in patients Date/time: Friday, October
23,
(pts) with high-risk biochemically recurrent 15:15-16:00
prostate cancer (hrBCR): EMBARK post
hoc analysis
Zolbetuximab
SPOTLIGHT ctDNA: ctDNA Assessment in K. Shitara Type: Poster
Patients with CLDN18.2+, HER2−, Locally Abstract number: 2882P
Advanced Unresectable or Metastatic (la/m) Date/time: Sunday, October
25,
Gastric or Gastroesophageal Junction 12:00-12:45
Adenocarcinoma (G/GEJ a) in SPOTLIGHT
Canadian PSP: Real-World Use of H. Karachiwala Type: Poster
Zolbetuximab Plus Chemotherapy (CTx) in Abstract number: 2941P
Patients With CLDN18.2+, HER2−, Locally Date/time: Sunday, October
25,
Advanced (LA) Unresectable or Metastatic 12:00-12:45
Gastric or Gastroesophageal Junction
Cancer (mGC/GEJC) in a Canadian
Patient Support Program (PSP)
Pipeline
Phase 3 PDAC TiP: A Phase 3, double-blind, T. Macarulla Type: Poster
randomized trial of setidegrasib + mFOLFIRINOX Abstract number: 3190TiP
or NALIRIFOX as first-line treatment for patients Date/time: Sunday, October
25,
with metastatic pancreatic ductal adenocarcinoma 12:00-12:45
(PDAC) harboring KRAS G12D mutations: Trial in
progress
Phase 3 NSCLC TiP: Phase 3, F. Skoulidis Type: ePoster
randomized, open-label trial of setidegrasib Abstract number: 2871eTiP
vs docetaxel in patients with KRAS G12D-mutated Date/time: N/A
locally advanced or metastatic non-small cell lung
cancer (NSCLC) that progressed on or after
platinum-based chemotherapy and checkpoint inhibitor
(CPI) therapy: Trial in progress
Phase 1b/2 TiP: Phase 1b/2 study of T. Macarulla Type: ePoster
ASP546C, a Claudin 18.2-targeting Abstract number: 1133eTiP
antibody-drug conjugate with a Date/time: N/A
topoisomerase 1 inhibitor payload, in
patients with Claudin 18.2-expressing
unresectable locally advanced or metastatic
solid tumors
FiH TiP: A phase 1 study of ASP5834 in
S. Sen Type: ePoster
patients with locally advanced or metastatic Abstract number: 1145eTiP
solid tumors with Kirsten rat sarcoma viral Date/time: N/A
oncogene homologue (KRAS) mutations or
amplifications
Combination clinical data for mss CRC:
V. Boni Type: ePoster
A phase 1/2 study of ASP1570 for locally Abstract number: 1090eP
advanced/metastatic microsatellite-stable Date/time: N/A
(MSS) colorectal cancer (CRC)
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 PADCEV and the Pfizer, Astellas and MSD Collaboration
Seagen and Astellas previously entered a clinical collaboration agreement with MSD to evaluate the combination of Seagen's and Astellas' PADCEVTM (enfortumab vedotin) and MSD's KEYTRUDA® (pembrolizumab) in patients with urothelial cancer. 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.
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