Tislelizumab-induced hyperamylasemia: Case report and safety analysis using the FAERS database

OBJECTIVE: To present a case report involving hyperamylasemia caused by tislelizumab and to assess the safety of tislelizumab using the FDA Adverse Event Reporting System (FAERS) database. BACKGROUND: Although the anti-PD-1 monoclonal antibody tislelizumab is approved by the FDA, the small cohort sample sizes in clinical trials fail to support a thorough safety assessment, especially for immune-related adverse reactions. CASE REPORT: A 69-year-old patient developed tislelizumab-related hyperamylasemia after 6 cycles of combination immunotherapy with pemetrexed, tislelizumab, and carboplatin. A total of 5,778 tislelizumab-associated adverse event reports, mainly from China, were retrieved from the FAERS database. Four positive signals were identified at the system organ class (SOC) level and 122 positive signals at the preferred term (PT) level. At the SOC level, tislelizumab exhibited the strongest correlation with blood and lymphatic system disorders (ROR = 24.11, 95% CI: 23.11 - 25.14). At the PT level, myelosuppression was the most significant adverse signal (ROR = 737.29, 95% CI: 705.23 - 770.82). In the SOC category of Investigations, tislelizumab was correlated with decreased counts of neutrophils, white blood cells, platelets and lymphocytes, elevated hepatic enzymes, and increased amylase levels, which was consistent with the manifestation of our presented case. CONCLUSION: Tislelizumab is associated with multisystem adverse events. Close monitoring of serum amylase levels, as well as regular hematological and biochemical examinations, is essential during clinical medication.