Abstract 426P
Background
Capmatinib, approved by the FDA in 2020, is a targeted therapy for non-small cell lung cancer (NSCLC) with MET exon 14 mutations (METex14). Given the limited real-world safety data, this study aimed to identify significant adverse drug reactions (ADRs) associated with Capmatinib in NSCLC patients using the FDA Adverse Event Reporting System (FAERS).
Methods
Four primary algorithms were employed for disproportionality analysis: reported odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and Empirical Bayes Geometric Mean (EBGM). Adverse events (AEs) were classified as ADRs only if they met criteria across all algorithms.
Results
An analysis of 1,767 cases identified 38 significant ADRs across 14 system-organ categories (SOCs). Notable findings included previously unlisted ADRs in the SOC “Ear and labyrinth disorders,” particularly “hypoacusis” and “deafness.”
Conclusions
This study highlights unexpected ADRs associated with Capmatinib in the treatment of NSCLC with METex14 mutations, emphasizing the need for increased clinical monitoring and further investigation into the underlying mechanisms. These findings provide valuable insights into the real-world safety profile of targeted therapies.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.