Astellas Pharma Announces Approval of VYLOYTM for Advanced Gastric Cancer
Monday, January 06, 2025
Astellas Pharma has announced that China’s National Medical Products Administration (NMPA) has approved VYLOYTM (zolbetuximab) for first-line treatment of patients with locally advanced, unresectable, or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Gastric and gastroesophageal junction cancers are closely related and share similar treatment guidelines. In 2022, over 358,000 new gastric cancer cases were reported in China. These cancers often go undetected in early stages due to non-specific symptoms, leading to late-stage diagnoses.
Advanced disease presents symptoms such as weight loss, fatigue, abdominal discomfort, and gastrointestinal bleeding.
The therapy, in combination with fluoropyrimidine- and platinum-based chemotherapy, specifically targets tumours expressing the claudin (CLDN) 18.2 biomarker. This marks the first approval of a monoclonal antibody in China designed to target CLDN18.2-positive gastric tumour cells, providing a precision treatment approach.
Gastric cancer remains a significant health challenge in China, where over 260,000 deaths were attributed to the disease in 2022. Diagnosis often occurs at advanced stages due to the subtle nature of early symptoms, leaving limited treatment options.
The average five-year survival rate for advanced gastric cancer in China is just 9.1%, underscoring the urgent need for innovative therapies.
The approval is backed by results from the global Phase 3 GLOW and SPOTLIGHT trials, which included Chinese patient subgroups. These studies demonstrated improved outcomes with zolbetuximab in combination with chemotherapy.
The GLOW trial showed a median progression-free survival (PFS) of 8.21 months with zolbetuximab plus CAPOX (capecitabine and oxaliplatin) compared to 6.80 months for the placebo group, with a median overall survival (OS) of 14.39 months versus 12.16 months.
Similarly, the SPOTLIGHT trial showed a median PFS of 10.61 months and median OS of 18.23 months for patients treated with zolbetuximab plus mFOLFOX6 (oxaliplatin, leucovorin, and fluorouracil), compared to 8.67 months and 15.54 months, respectively, in the placebo group.
The safety profile of zolbetuximab was consistent with standard care, with the most common adverse events including nausea, vomiting, and reduced appetite.
Approximately 35% of Chinese patients with advanced gastric or GEJ cancers are CLDN18.2-positive, making zolbetuximab a promising new treatment option. Its approval reflects Astellas Pharma's commitment to advancing precision oncology and addressing unmet medical needs in cancer care.
This approval by the NMPA represents a critical step forward in improving outcomes for patients with advanced gastric and GEJ cancers in China.
Source: astellas.com
