Frontiers in oncology · 2026
Safety signals of zolbetuximab in gastric or gastroesophageal junction adenocarcinoma: a comprehensive analysis of the FDA adverse event reporting system (FAERS) data.
СтатьяНазвание и аннотация: Перевод в очереди
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Lin Li, Chen Maohua, Wu Chenmin, Chen Hong
Аннотация
BACKGROUND: Zolbetuximab is a novel monoclonal antibody targeting CLDN18.2 for advanced gastric or gastroesophageal junction adenocarcinoma. However, its large-scale, real-world safety profile remains incompletely characterized. This study aimed to analyze its post-marketing adverse events using the FDA Adverse Event Reporting System (FAERS).
METHODS: Adverse event reports from FAERS (Q1 2024 - Q3 2025) with zolbetuximab as the primary suspect were analyzed. Disproportionality analysis using four algorithms (ROR, PRR, IC, and EBGM) was performed to detect potential safety signals. Time-to-onset analysis was also conducted.
RESULTS: A total of 676 reports were analyzed. Disproportionality analysis confirmed known gastrointestinal and metabolic disorders while identifying several unlabeled adverse events, including but not limited to gastritis, protein-losing gastroenteropathy, peripheral edema, compression fracture, and vascular pain. The median time-to-onset was 0 days, with 82.9% of events occurring within the first 30 days.
CONCLUSION: This first large-scale pharmacovigilance study of zolbetuximab detected several potential safety signals not currently listed in the prescribing information. These findings highlight the importance of post-marketing surveillance and should be interpreted as hypothesis-generating, warranting further validation in clinical and real-world studies.
METHODS: Adverse event reports from FAERS (Q1 2024 - Q3 2025) with zolbetuximab as the primary suspect were analyzed. Disproportionality analysis using four algorithms (ROR, PRR, IC, and EBGM) was performed to detect potential safety signals. Time-to-onset analysis was also conducted.
RESULTS: A total of 676 reports were analyzed. Disproportionality analysis confirmed known gastrointestinal and metabolic disorders while identifying several unlabeled adverse events, including but not limited to gastritis, protein-losing gastroenteropathy, peripheral edema, compression fracture, and vascular pain. The median time-to-onset was 0 days, with 82.9% of events occurring within the first 30 days.
CONCLUSION: This first large-scale pharmacovigilance study of zolbetuximab detected several potential safety signals not currently listed in the prescribing information. These findings highlight the importance of post-marketing surveillance and should be interpreted as hypothesis-generating, warranting further validation in clinical and real-world studies.