Real-world safety of Tepotinib: Insights from the Food and Drug Administration Adverse Event Reporting System

Tepotinib is widely utilized for treating non-small cell lung cancer (NSCLC) patients with MET exon 14 (METex14) skipping mutations. The purpose of this study is to evaluate the safety characteristics of Tepotinib in the actual environment by analyzing data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

This study analyzed adverse event (AE) reports related to Tepotinib from FAERS database spanning Q1 2021 to Q4 2024. Four disproportionality analysis methods were employed: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-Item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN). A descriptive analysis and a subgroup analysis of the time to onset (TTO) of AEs was conducted, and the Weibull distribution was used to predict temporal variations in AEs.

A total of 521 AE reports involving 1,385 AEs were included in this study. Of these, 69.50% were from the elderly population. The analysis confirmed several known AEs such as death, peripheral edema, diarrhea, and blood creatinine increased while also identifying previously unreported signals, including deafness and taste disorder. For females, special attention ought to be directed toward alopecia, deafness and abdominal pain upper. For males, the onset of interstitial lung disease, pruritus and constipation requires observation. The median time to onset (TTO) of AEs was 39 days, with 43.88% of AEs occurring in the first month of treatment initiation. Additionally, the individuals aged 75 years and over the experience AEs relatively early.

This study conducted a comprehensive evaluation of the real-world safety of Tepotinib. The study validates clinical assertions about Tepotinib's safety profile and identifies its novel signals, and also emphasized early monitoring of treatment. Our findings will better guide the clinical practice of Tepotinib and provide a basis for larger prospective studies in the future.