Astellas Highlights Data Advancing Cancer Care and Innovation for Patients with Hard-to-Treat Cancers at ESMO 2026

PR Newswire

TOKYO, Oct. 6, 2026

–  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.

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.(PRNewsFoto/Astellas Pharma Inc.)

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
Analysis: Enfortumab vedotin with or
without pembrolizumab as first-line
treatment for cisplatin (cis)-ineligible locally
advanced or metastatic urothelial
carcinoma: long-term follow-up analysis
from EV-103 cohorts DE/A and K

J. P. Maroto Rey

Type: Rapid oral
Abstract number: 4740RO
Date/time: Saturday, October 24,
10:15-11:45

EV-302 Comorbidities (DCO3): 
Enfortumab vedotin plus pembrolizumab for
previously untreated locally advanced or
metastatic urothelial carcinoma: updated
exploratory analysis of EV-302 in older
patients and those with comorbidities

S. S. Sridhar

Type: Poster
Abstract number: 4761P
Date/time: Friday, October 23,
15:15-16:00

EV-302 Clinical Subgroups (DCO3): 
Enfortumab vedotin + pembrolizumab in
previously untreated locally advanced or
metastatic urothelial cancer: exploratory
analyses based on disease-related
characteristics from EV-302

J. Bedke

Type: Poster
Abstract number: 4760P
Date/time: Friday, October 23,
15:15-16:00

EVOLVE 3: Real-world treatment patterns
in patients with locally advanced and
metastatic urothelial cancer in France

F. Joly

Type: ePoster

EV-303/KN-905 ITT3: Perioperative
pembrolizumab or enfortumab vedotin plus
pembro in participants with muscle-invasive
bladder cancer who are cisplatin-ineligible:
ad hoc analysis from KEYNOTE-905

A. Ullén

Type: Proffered paper session
Abstract number: 4733O
Date/time: Friday, October 23,
13:30-15:00

EV-304/KN-B15 ctDNA: ctDNA analysis of
the phase 3 KEYNOTE-B15 trial:
neoadjuvant and adjuvant enfortumab
vedotin + pembrolizumab for participants
with muscle-invasive bladder cancer who
are eligible for cisplatin

J. Chatzkel

Type: Proffered paper session
Abstract number: 4734O
Date/time: Friday, October 23,
13:30-15:00

EV-304/KN-B15 ePRO: Health-related
quality of life with neoadjuvant and adjuvant
enfortumab vedotin plus pembrolizumab in
participants (pts) with muscle-invasive
bladder cancer eligible for cisplatin in the
phase 3 KEYNOTE-B15 study

A. Gómez De Liaño

Type: Rapid oral
Abstract number: 4738RO
Date/time: Saturday, October 24,
10:15-11:45

EV-209 TiP: EV-209: an open-label, single-arm,
phase 2 study of enfortumab vedotin plus
pembrolizumab for bladder preservation in
patients with muscle-invasive bladder cancer
eligible for radical cystectomy

Thomas Powles

Type: Poster
Abstract number: 4769TiP
Date/time: Friday, October 23,
15:15-16:00

EV-309 TiP: EV-309: an open-label,
randomized, phase 3 study of enfortumab
vedotin plus pembrolizumab for bladder
preservation in patients with muscle-invasive
bladder cancer

Matthew D. Galsky

Type: Poster
Abstract number: 4770TiP
Date/time: Friday, October 23,
15:15-16:00

Enzalutamide

Adelpi REALIZE: High-risk biochemically
recurrent (hrBCR) hormone sensitive
prostate cancer (PC): European real-world
(RW) evidence on risk stratification, PSMA
PET use, and physician practices

A. Merseburger

Type: ePoster
Abstract number: 2063eP
Date/time: N/A

AMNOG NMA in mHSPC: Network meta-analysis
(NMA) on the safety of androgen receptor pathway
inhibitors (ARPIs) in patients with metastatic
hormone-sensitive prostate cancer (mHSPC) from
German AMNOG dossiers

C. Ohlmann

Type: Poster
Abstract number: 2295P
Date/time: Friday, October 23,
15:15-16:00

CASPER: Outcomes of enzalutamide
(ENZ) and apalutamide (APA) in metastatic
hormone-sensitive prostate cancer
(mHSPC): a Canadian real-world (RW) study

B. Shayegan

Type: ePoster
Abstract number: 2329eP
Date/time: N/A

ARCHES/ARANOTE indirect safety
comparison: Indirect safety comparison of
enzalutamide (ENZA) and darolutamide
(DARO) with androgen-deprivation therapy
(ADT) in metastatic hormone-sensitive
prostate cancer (mHSPC)

S. Shariat

Type: Poster
Abstract number: 2294P
Date/time: Friday, October 23,
15:15-16:00

EMBARK deep PSA response: Deep
prostate-specific antigen (PSA) response
by prior definitive treatment (tx) in patients
(pts) with high-risk biochemically recurrent
prostate cancer (hrBCR): EMBARK post
hoc analysis

S. Freedland

Type: Poster
Abstract number: 2293P
Date/time: Friday, October 23,
15:15-16:00

Zolbetuximab

SPOTLIGHT ctDNA: ctDNA Assessment in
Patients with CLDN18.2+, HER2−, Locally
Advanced Unresectable or Metastatic (la/m)
Gastric or Gastroesophageal Junction
Adenocarcinoma (G/GEJ a) in SPOTLIGHT

K. Shitara

Type: Poster
Abstract number: 2882P
Date/time: Sunday, October 25,
12:00-12:45

Canadian PSP: Real-World Use of
Zolbetuximab Plus Chemotherapy (CTx) in
Patients With CLDN18.2+, HER2−, Locally
Advanced (LA) Unresectable or Metastatic
Gastric or Gastroesophageal Junction
Cancer (mGC/GEJC)  in a Canadian
Patient Support Program (PSP)

H. Karachiwala

Type: Poster
Abstract number: 2941P
Date/time: Sunday, October 25,
12:00-12:45

Pipeline

Phase 3 PDAC TiP: A Phase 3, double-blind,
randomized trial of setidegrasib + mFOLFIRINOX
or NALIRIFOX as first-line treatment for patients
with metastatic pancreatic ductal adenocarcinoma
(PDAC) harboring KRAS G12D mutations: Trial in
progress

T. Macarulla

Type: Poster
Abstract number: 3190TiP
Date/time: Sunday, October 25,
12:00-12:45

Phase 3 NSCLC TiP: Phase 3,
randomized, open-label trial of setidegrasib
vs docetaxel in patients with KRAS G12D-mutated
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

F. Skoulidis

Type: ePoster
Abstract number: 2871eTiP
Date/time: N/A

Phase 1b/2 TiP: Phase 1b/2 study of
ASP546C, a Claudin 18.2-targeting
antibody-drug conjugate with a
topoisomerase 1 inhibitor payload, in
patients with Claudin 18.2-expressing
unresectable locally advanced or metastatic
solid tumors

T. Macarulla

Type: ePoster
Abstract number: 1133eTiP
Date/time: N/A

FiH TiP: A phase 1 study of ASP5834 in
patients with locally advanced or metastatic
solid tumors with Kirsten rat sarcoma viral
oncogene homologue (KRAS) mutations or
amplifications

S. Sen

Type: ePoster
Abstract number: 1145eTiP
Date/time: N/A

Combination clinical data for mss CRC:
A phase 1/2 study of ASP1570 for locally
advanced/metastatic microsatellite-stable
(MSS) colorectal cancer (CRC)

V. Boni

Type: ePoster
Abstract number: 1090eP
Date/time: N/A

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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