Astellas Pharma Inc. announced that the National Medical Products Administration of China has approved VYLOY (zolbetuximab), in combination with chemotherapy containing fluoropyrimidine and platinum, for the first-line treatment of patients with gastric adenocarcinoma or gastroesophageal junction locally advanced, unresectable or metastatic, human epidermal growth factor receptor 2 (HER2) negative, and tumors positive with claudin 18.2. Zolbetuximab is the first monoclonal antibody approved by the ANSM to target gastric tumor cells that express the biomarker CLDN18.2, thus providing a highly targeted approach to cancer treatment. Gastric cancer is the third leading cause of cancer-related mortality in China, with more than 260,000 deaths reported in 2022.5 Because early symptoms are often difficult to detect, approximately 60% of Chinese patients are diagnosed at an advanced stage of the disease, where Therapeutic options are limited and results are often poor.
The average five-year survival rate of patients with advanced gastric cancer in China is 9.1%, hence the urgent need for new treatment options that can slow the progression of the disease and prolong the life span. life. The APMN’s approval of zolbetuximab is based on data from the global phase 3 clinical trials GLOW and SPOTLIGHT, which included 145 and 36 patients from mainland China, respectively. The GLOW trial evaluated zolbetuximab plus CAPOX (a combination chemotherapy including capecitabine and oxaliplatin) versus placebo plus CAPOX.
The SPOTLIGHT trial evaluated zolbetuximab plus mFOLFOX6 (a chemotherapy combination including oxaliplatin, leucovorin, and fluorouracil) versus placebo plus mFOLFOX6. Treatment with zolbetuximab has been shown to provide statistically significant improvements in progression-free survival and overall survival compared to other standard chemotherapies in eligible patients with gastric and genitourinary cancers. In the GLOW trial, a median PFS of 8.21 months was achieved with zolbetuximab plus CAPOX as first-line treatment, compared to 6.80 months with placebo plus CAPOX.
Median OS was 14.39 months versus 12.16 months in the respective treatment groups. Similar efficacy results were observed in the SPOTLIGHT trial, where median PFS was 10.61 months versus 8.67 months, and median OS was 18.23 months versus 15.54 months, with zolbetuximab plus mFOLFOX6, compared to placebo plus mFOLFOX6. In the GLOW and SPOTLIGHT trials, the incidence of treatment-emergent serious adverse events (TEAEs) was similar in the zolbetuximab-treated groups and the control groups.
The most common adverse reactions of all grades reported in the zolbetuximab-treated groups were nausea, vomiting, and decreased appetite. Astellas has already factored in the impact of the NMPA approval of zolbetuximab in its financial guidance for the current fiscal year ending March 31, 2025.
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