China’s National Medical Products Administration (NMPA) has approved Vyloytm (zolbetuximab) for use alongside fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with locally advanced, unresectable, or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The approval applies to patients whose tumors express claudin 18.2 (CLDN18.2), a biomarker found in approximately 35% of individuals in China with these cancers. This makes zolbetuximab the first monoclonal antibody in China designed to target CLDN18.2, offering a new, precise option for treating gastric cancer.
Gastric cancer remains a significant health concern in China, ranking as the third most common cause of cancer-related deaths. In 2022, more than 260,000 individuals in the country died from this disease. Early symptoms are often subtle or absent, which leads to around 60% of patients receiving a diagnosis at an advanced stage, when treatment options are limited and survival outcomes are poor. The five-year survival rate for advanced gastric cancer patients in China stands at just 9.1%. This highlights the urgent need for innovative therapies that can help extend survival and slow disease progression.
The approval of Vyloytm by the NMPA is based on data from two global Phase 3 clinical trials, known as GLOW and SPOTLIGHT. These studies included participants from mainland China, with 145 patients enrolled in GLOW and 36 in SPOTLIGHT. The GLOW trial compared the combination of zolbetuximab with CAPOX (capecitabine and oxaliplatin) against a placebo plus CAPOX. Meanwhile, the SPOTLIGHT trial evaluated zolbetuximab with mFOLFOX6 (oxaliplatin, leucovorin, and fluorouracil) in comparison to a placebo plus mFOLFOX6.
In both trials, zolbetuximab demonstrated a significant improvement in progression-free survival (PFS) and overall survival (OS) compared to standard chemotherapy alone. During the GLOW study, patients receiving zolbetuximab with CAPOX experienced a median PFS of 8.21 months, versus 6.80 months for those given a placebo. The median OS in the zolbetuximab group was 14.39 months, compared to 12.16 months for the placebo group.
Similarly, the SPOTLIGHT trial showed median PFS of 10.61 months with zolbetuximab and mFOLFOX6, compared to 8.67 months with the placebo regimen. Overall survival was extended to 18.23 months in the zolbetuximab group, while patients in the placebo group experienced a median OS of 15.54 months.
Across both trials, serious treatment-emergent adverse events (TEAEs) were reported at similar rates in zolbetuximab and placebo groups. Common side effects associated with zolbetuximab included nausea, vomiting, and reduced appetite.
Astellas Pharma has accounted for the anticipated impact of this approval in its financial outlook for the fiscal year ending March 31, 2025.
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