China Approves VYLOY for First-Line Treatment of Advanced Gastric Cancer

In a significant advancement for cancer treatment in China, Astellas Pharma Inc. announced that the Chinese National Medical Products Administration (NMPA) has approved VYLOYTM (zolbetuximab) for use in combination with specific chemotherapy regimens as a first-line treatment for patients with specific types of gastric cancer. This approval marks the first time a monoclonal antibody targeting CLDN18.2, a gastric cancer biomarker, has been approved in China, providing a new precision medicine option for patients in need.

Gastric cancer poses a substantial health burden in China, being the third leading cause of cancer-related deaths. The disease often goes undetected until it reaches an advanced stage, which limits treatment options and results in poor prognoses. In 2022 alone, over 260,000 people in China died from gastric cancer. With the disease often diagnosed late, the five-year survival rate for advanced cases remains alarmingly low at 9.1%. This creates a critical demand for innovative therapies that can improve both survival and quality of life.

Zolbetuximab, the newly approved treatment, targets the CLDN18.2 protein expressed in some gastric and gastroesophageal junction (GEJ) tumors. Approximately 35% of Chinese patients with advanced forms of these cancers have tumors that express this biomarker. By focusing on CLDN18.2, zolbetuximab promotes selective cell death, thus potentially reducing the number of cancerous cells.

The approval was greatly influenced by data from the global Phase 3 GLOW and SPOTLIGHT clinical trials, which included a significant number of participants from China. These trials explored the efficacy and safety of zolbetuximab combined with chemotherapy regimens CAPOX and mFOLFOX6. Results showed that zolbetuximab significantly improved progression-free survival (PFS) and overall survival (OS) compared to standard chemotherapy regimens. In the GLOW trial, patients receiving zolbetuximab and CAPOX had a median PFS of 8.21 months compared to 6.80 months with the placebo. Similarly, the SPOTLIGHT trial reported a median PFS of 10.61 months for zolbetuximab plus mFOLFOX6, compared to 8.67 months for the placebo group.

The trials demonstrated that zolbetuximab not only extends survival but is also tolerable, with the most common side effects being nausea, vomiting, and decreased appetite. The incidence of serious adverse events was comparable between those receiving the drug and the placebo groups.

Leading oncologists in China, such as Professor Xu Ruihua and Professor Xu Jianming, have underscored the importance of this development. They emphasize the remarkable benefits shown in the Chinese subgroup of the clinical trials, highlighting improvements in both survival outcomes and quality of life for patients. These findings have substantial implications for meeting the clinical needs of Chinese patients with advanced gastric cancer.

Zolbetuximab's approval aligns with Astellas Pharma's commitment to advancing cancer treatment through targeted therapies. The company's dedication to innovation in oncology has led to the introduction of this groundbreaking treatment, offering hope for better management of advanced gastric cancer in China and potentially setting a precedent for other precision medicines in the future.