Safety evaluation of tarlatamab: A pharmacovigilance study based on the FAERS database

Tarlatamab (Imdelltra, AMG757) has been approved for extensive-stage small cell lung cancer (ES-SCLC) treatment, yet post-marketing data remain limited. Existing studies lack conclusive evidence on its real-world safety profile.

Leveraging the FDA Adverse Event Reporting System (FAERS), this study evaluated adverse events (AEs) attributed to Tarlatamab between Q2 2024 and Q1 2025. Disproportionality analysis using reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) quantified associations between Tarlatamab and AEs.

Among 448 analyzed AE reports, the median time to AE onset was 5.0 days. Tarlatamab-associated AEs reports showed elevated hospitalization (21.7 %) and fatality rates (16.7 %). Significant signals emerged across 5 System Organ Classes (SOCs) and 31 Preferred Terms (PTs), including unlabeled events: atrial fibrillation (IC025: 0.77), ageusia (IC025: 3.79), mental status changes (IC025: 2.45), and unresponsiveness to stimuli (IC025: 2.22). Notable discrepancies with labeled information included dual hypertension (IC025: 0.18) and hypotension (IC025: 1.61) signals, suggesting complex blood pressure effects, and a higher mortality risk in male patients. Mild AEs correlated with reduced severe outcome risks.

These findings offer critical insights for clinicians to identify and manage Tarlatamab-related AEs, highlighting underestimated risks and informing tailored practice.