Astellas to Share New Data Across Hard-to-Treat Cancers During ESMO Congress 2023

• Data include three late-breaking abstracts, underscoring Astellas’ efforts to potentially redefine expectations for patients across its oncology portfolio

Astellas Pharma will share new research results during the European Society for Medical Oncology (ESMO) Congress 2023 from October 20-24, showcasing the company’s focus on making a meaningful difference for people living with hard-to-treat cancers. A total of 13 abstracts will be presented, highlighting data from two established medicines and one investigational therapy, across prostate, urothelial and gastric/gastroesophageal junction (GEJ) cancers.

Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas
“At Astellas, we’re working to change the course of cancer care, including through scientific advancements to address pressing unmet needs. We look forward to sharing our latest investigational data at ESMO, including data from the Phase 3 EV-302 study of enfortumab vedotin, which is developed in partnership with Seagen, in combination with Merck’s pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer in a late-breaking presentation. We will also present expanded data from a Phase 3 study investigating enzalutamide plus leuprolide in patients with nonmetastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence.”

Moitreyee Chatterjee-Kishore, PhD, MBA, Senior Vice President and Head of Immuno-Oncology Development, Astellas
“Over the last several months, Astellas has demonstrated considerable progress in our efforts to make a purposeful impact in the care of patients with advanced gastric cancer through regulatory submissions for our investigational therapy, zolbetuximab, across the U.S., Asia, and Europe. During ESMO, we will share updated data from two Phase 3 clinical studies, highlighting important clinical data of zolbetuximab in gastric and GEJ cancer patients whose tumors are CLDN18.2-positive.”

Other highlights at the ESMO Congress 2023 include:

• Data from Cohort L of the EV-103 study evaluating enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC)
• Health-related quality of life (HRQoL) data from the Phase 3 SPOTLIGHT and GLOW trials, evaluating zolbetuximab as a first-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma whose tumors are CLDN18.2-positive
• HRQoL data in nonmetastatic hormone-sensitive prostate cancer (nmHSPC) patients with high-risk biochemical recurrence (BCR) from the EMBARK study evaluating enzalutamide plus leuprolide, leuprolide plus placebo and enzalutamide monotherapy

Astellas Presentations at ESMO Congress 2023

Enfortumab Vedotin

Enzalutamide

Zolbetuximab

About the Astellas, Seagen and Merck Collaboration
Astellas and Seagen entered a clinical collaboration agreement with Merck to evaluate the combination of Astellas and Seagen's PADCEV^® (enfortumab vedotin-ejfv) and Merck's KEYTRUDA^® (pembrolizumab) in patients with previously untreated metastatic urothelial cancer. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

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 U.S. Pfizer receives alliance revenues as a share of U.S. profits and receives royalties on sales outside the U.S.

Om Astellas

Astellas Pharma är ett företag som fokuserar på att förbättra människors hälsa runt om i världen genom att tillhandahålla innovativa och tillförlitliga läkemedel. Vi är främst verksamma inom sjukdomsområdena urologi och onkologi. Astellas vision är att ligga i framkant av vårdutvecklingen och skapa värde för patienter genom innovativ forskning och vetenskap. Med det nordiska huvudkontoret i Köpenhamn finns Astellas representerat i hela Norden. För mer information, besök vår hemsida www.astellas.se

För mer information kontakta

Camille Claudius, senior medicinsk direktör, Astellas Pharma, camille.claudius@astellas.com, +45 4343 0355

MAT-SE-NON-2023-00079