Astellas Highlights Oncology Progress at 2024 ASCO Meeting

Astellas Pharma Inc. will present new research findings from its portfolio of approved and investigational cancer therapies during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled from May 31 to June 4. The presentation will include 16 abstracts, showcasing new data from pivotal trials and supporting ongoing regulatory reviews. Astellas' commitment to revolutionizing cancer treatment is underscored by its focus on targeted therapies for challenging cancers such as prostate, urothelial, and gastric/gastroesophageal junction (GEJ) cancers.

Dr. Tadaaki Taniguchi, Astellas' Chief Medical Officer, emphasized that the data being presented at ASCO highlights the extensive and growing oncology portfolio of the company. These new insights demonstrate the transformative potential of Astellas' therapies for patients facing some of the most severe forms of cancer. The recent regulatory achievements have allowed Astellas' oncology medicines to reach a broader patient base globally. The company remains dedicated to pursuing novel targets and investing in research aimed at improving overall survival rates and enhancing patients' quality of life.

Key highlights of the 2024 ASCO Annual Meeting include:

1. Phase 3 EV-302 Trial Data: Enfortumab vedotin, combined with pembrolizumab, was evaluated against chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). This includes data for both cisplatin-eligible and ineligible populations. The results indicate a significant advancement in the care of la/mUC patients, supporting ongoing regulatory reviews by agencies such as the European Medicines Agency (EMA), Japan's Ministry of Health, Labour and Welfare (MHLW), and China’s National Medical Products Administration (NMPA).

2. Phase 3 SPOTLIGHT Study Results: Final overall survival results were presented for zolbetuximab, a first-in-class claudin 18.2-targeted monoclonal antibody. Approved by Japan's MLHW and under review by various global regulatory authorities, zolbetuximab was tested in combination with mFOLFOX6 chemotherapy. This study targeted patients with CLDN18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. The findings bolster the clinical data supporting zolbetuximab's regulatory approval pursuits worldwide.

3. Phase 3 EMBARK Trial Analyses: Two post-hoc analyses were presented from the EMBARK trial, which evaluated enzalutamide plus leuprolide, placebo plus leuprolide, and enzalutamide as a single agent in patients with nonmetastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence. These analyses included an oral presentation on the impact of treatment suspension on health-related quality of life, and a poster presentation on patient-reported outcomes regarding sexual activity.

Astellas' presentations at the ASCO Annual Meeting represent a collaborative effort in advancing cancer treatment. Notably, Astellas and Pfizer have a clinical collaboration with Merck to evaluate the combination of Astellas' and Pfizer's PADCEV (enfortumab vedotin-ejfv) and Merck's KEYTRUDA (pembrolizumab) in previously untreated metastatic urothelial cancer patients. Additionally, Astellas and Pfizer jointly develop and commercialize XTANDI (enzalutamide) in the United States, while Astellas handles global manufacturing, regulatory filings, and commercialization outside the United States.

Astellas Pharma Inc., operating in over 70 countries, focuses on creating new drugs for diseases with high unmet medical needs by emphasizing Biology and Modality in its Focus Area Approach. Furthermore, Astellas aims to develop innovative Rx+ healthcare solutions by integrating its expertise with cutting-edge technology from various external partners. Through these efforts, Astellas is at the forefront of healthcare innovation, transforming scientific advancements into valuable patient treatments.

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