Astellas Showcases Scientific Advances in Oncology Portfolio at ASCO 2024 with New Data Across Hard-to-Treat Cancers

16 Abstracts Highlight New Data and Post Hoc Analyses from Key Trials in Multiple Refractory Cancers

Astellas Pharma, Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will participate in the American Society of Clinical Oncology (ASCO) held from May 31 to June 4, 2024.ASCO) at the annual meeting to share new research findings on its innovative cancer treatment drug combination. At this meeting, 16 abstracts will be presented, including new data from pivotal trials currently under regulatory review. These research advancements demonstrate Astellas' commitment toTargeted TherapyTransforming Refractory Cancers (e.g.,Prostate Cancer, urothelial carcinoma, and gastric/gastroesophageal junction cancer) treatment progress commitment.

Tadaaki Taniguchi, Chief Medical Officer of Astellas，Doctor of Medicine

"The data presented at the ASCO Annual Meeting demonstrate the strength and breadth of our expanding oncology portfolio, offering transformative new treatment insights for cancer patients facing serious health threats. Recent progress in regulatory approvals indicates that our oncology drugs will benefit more patients worldwide. We will continue to drive innovation and maintain our commitment to extending overall survival and improving the lives of cancer patients."Quality of Life。”

In2024 ASCOBigYes.DisplayHighlights include:

•  Further Data from the EV-302 Trial: Evaluation of the efficacy of enfortumab vedotin in combination with pembrolizumab compared to chemotherapy in previously untreated patients with locally advanced or metastatic urothelial carcinoma (la/mUC), including data from both cisplatin-tolerant and cisplatin-intolerant populations. These results support this treatment combination as a significant advancement for patients with la/mUC, paving the way for regulatory submissions in Europe.ManagementThe European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), Japan's Ministry of Health, Labour and Welfare (MHLW), and China's National Medical Products Administration (NMPA) are conducting registration reviews.

•  Final Overall Survival (OS) Results of the SPOTLIGHT Study: Evaluation of Zolbetuximab (a first-in-class monoclonal antibody targeting Claudin (CLDN) 18.2, approved by Japan's MHLW and under review by multiple regulatory agencies worldwide) in combination with mFOLFOX6 (a regimen containing oxaliplatin, leucovorin, andFluorouracilThe safety and efficacy of the combination chemotherapy regimen) in combination with zolbetuximab for the first-line treatment of patients with CLDN18.2-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. These results strongly support the clinical data of zolbetuximab, driving its regulatory submissions worldwide.

•  Two New Post-hoc Analyses of the EMBARK Trial: This trial evaluated the efficacy of enzalutamide plus leuprolide, placebo plus leuprolide, and enzalutamide monotherapy in patients with high-risk biochemical recurrence (BCR) non-metastatic hormone (or castration)-sensitive prostate cancer (nmHSPC or nmCSPC), including an oral presentation on the impact of treatment discontinuation on health-related quality of life and a poster presentation on patient-reported outcomes regarding sexual activity.