Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the National Medical Products Administration (NMPA) of China has approved VYLOY™ (zolbetuximab) for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric and gastroesophageal junction (GEJ) adenocarcinoma expressing the biomarker claudin (CLDN) 18.2. Zolbetuximab is the first therapy in China to specifically target CLDN18.2-positive tumors, a biomarker present in 35% of Chinese patients with advanced gastric and GEJ cancers.

Gastric cancer remains a critical public health challenge in China, with the highest global burden of cases and deaths. In 2022 alone, over 260,000 deaths were attributed to the disease. Most patients are diagnosed at an advanced stage, with limited treatment options and a poor five-year survival rate of just 9.1%. The approval of zolbetuximab represents a major milestone in addressing this unmet medical need.

Clinical Evidence Supporting Approval

The NMPA's decision was based on data from the Phase 3 GLOW and SPOTLIGHT clinical trials, which demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) for patients treated with zolbetuximab in combination with chemotherapy compared to chemotherapy alone. Key findings include:

• GLOW Trial: Median PFS of 8.21 months and OS of 14.39 months with zolbetuximab plus CAPOX, compared to 6.80 months and 12.16 months, respectively, with placebo.
• SPOTLIGHT Trial: Median PFS of 10.61 months and OS of 18.23 months with zolbetuximab plus mFOLFOX6, compared to 8.67 months and 15.54 months, respectively, with placebo.

The safety profile of zolbetuximab was consistent across trials, with manageable side effects such as nausea, vomiting, and decreased appetite.

Professor Xu Ruihua, Lead Investigator of the GLOW Trial and President of the Chinese Society of Clinical Oncology (CSCO), emphasized the importance of the approval:
"Zolbetuximab offers significant survival benefits for Chinese patients with advanced gastric cancer. Its inclusion in first-line treatment regimens will transform outcomes for patients with CLDN18.2-positive tumors."

Professor Xu Jianming, Lead Investigator of the SPOTLIGHT Trial in China, highlighted the broader implications:
"The approval of zolbetuximab reflects a growing focus on precision medicine in China. This innovative therapy sets a new benchmark for the treatment of advanced gastric cancer."

Advancing Precision Oncology in China

Zolbetuximab is the first monoclonal antibody in China designed to target CLDN18.2, a biomarker uniquely expressed on gastric tumor cells. By binding to CLDN18.2, zolbetuximab enables selective destruction of tumor cells, offering a novel therapeutic strategy with the potential to extend survival and improve quality of life.

Dr. Moitreyee Chatterjee-Kishore, Senior Vice President and Head of Immuno-Oncology Development at Astellas, stated:
"The approval of zolbetuximab reinforces Astellas' commitment to advancing precision oncology and addressing the critical needs of gastric cancer patients in China."

Looking Ahead

Astellas continues to prioritize innovation in oncology, leveraging its global expertise to bring cutting-edge therapies to markets worldwide. The company has incorporated the impact of zolbetuximab's approval into its financial forecast for the fiscal year ending March 31, 2025.