Real-world analysis of adverse events associated with KIMMTRAK in metastatic uveal melanoma using the FAERS database.

Abstract

e21511 Background: KIMMTRAK (tebentafusp-tebn) is a bispecific T-cell engager approved for the treatment of metastatic uveal melanoma, a rare but aggressive cancer. While the drug’s efficacy is well-documented, adverse events (AEs) present significant clinical challenges. This study aimed to evaluate and quantify the AEs associated with KIMMTRAK using real-world data from the FDA Adverse Event Reporting System (FAERS). Methods: Adverse event data were analyzed from the FAERS database between 2022 and 2024. The classification of AEs was performed using standardized Medical Dictionary for Regulatory Activities (MedDRA) terms. Disproportionality analysis was conducted using the Reporting Odds Ratio (ROR) with a 95% confidence interval (CI) to identify significant signals. The study included only AEs reported at least 25 times and all reports involving death. This threshold was chosen to focus on commonly observed events while excluding minor occurrences to ensure clinical relevance. A signal was deemed significant when the lower limit of the 95% CI exceeded 1. Results: A total of 171 adverse event reports identifying KIMMTRAK as the primary suspect were analyzed. Significant disproportionality signals were observed for multiple immune-mediated and serious reactions. Among the demographic data, patients aged 65–85 years accounted for 27.27% of the reports, with males comprising 35.91% of cases. Most reports (74.55%) were submitted by healthcare professionals. Cytokine release syndrome was the most commonly reported adverse event, with 39 cases (ROR: 21.28, 95% CI: 12.72–35.40), followed by pyrexia with 37 cases (ROR: 8.92, 95% CI: 5.94–13.40) and hypotension with 33 cases (ROR: 5.47, 95% CI: 3.76–7.97). Dermatologic reactions such as rash were reported in 25 cases (ROR: 3.12, 95% CI: 2.07–4.72). Notably, disease progression was observed in 25 cases (ROR: 2.45, 95% CI: 1.41–4.25), highlighting potential concerns beyond immediate drug-related toxicities. Serious outcomes such as death were reported in 12 cases, (ROR: 1.84, 95% CI: 1.05–3.22). Conclusions: KIMMTRAK is associated with adverse events, including cytokine release syndrome, pyrexia, and hypotension. This real-world pharmacovigilance data obtained from the FAERS database provide valuable insights into the safety profile of KIMMTRAK, supporting its optimized use in clinical practice. Further research is necessary to validate and expand upon these findings to ensure improved patient outcomes.