Presentation (CTI)

OBJECTIVES: Lung cancer is the leading cause of cancer-related death globally, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of cases. As efficacy benefits converge, safety of targeted therapies for NSCLC could be the differentiator and impact patient and HCP experience. This study compared HCP submitted AE reports for ALK, BRAF, EGFR, RET, and VEGF inhibitors across US and EU.
METHODS: FAERS data from Q1 2020 to Q1 2025 were analyzed for AEs associated with ALK, BRAF, EGFR, RET, and VEGF inhibitors. HCP reported events were coded using Medical Dictionary for Regulatory Activities (MedDRA) preferred terms and mapped to System Organ Classes (SOCs). Descriptive statistics were stratified by reporting region (U.S. vs. EU).
RESULTS: We identified 91,309 HCP reported unique case reports. Most events related to ALK, BRAF, and VEGF inhibitors were reported in adult patients, while EGFR and RET inhibitors were more commonly associated with geriatric patients (~60%). AE reporting was equally distributed between the US and EU (~50% EU). Most AE reports due to ALK, BRAF, and EGFR inhibitors (~52% - 60% ) were reported in the US. as compared to RET and VEGF inhibitors in the EU (~52% - 57% ). The U.S. had higher rates of injury, poisoning, and procedural complications, while the EU reports more often fell under the Investigations, that captures abnormal parameter that suggests toxicity like change in blood creatine phosphokinase, weight etc.. Diarrhea was the most commonly reported adverse event across all five therapeutic classes.
CONCLUSIONS: While most of the organ-level adverse effects were similar, distinct differences in specific events were noted between HCP reporting in US and EU, indicating distinct treatment patterns and therapeutic experience for patients as reported by HCPs.