Real-world safety profile of T-cell engagers: evidence from multi-database analysis with CAR-T comparisons - PubMed
5 hours ago
- #pharmacovigilance
- #CAR-T therapy
- #T-cell engagers
- T-cell engagers (TCEs) are widely used immunotherapies, but their real-world safety profile is not fully understood.
- A pharmacovigilance study analyzed adverse events (AEs) from FAERS and VigiBase, comparing TCEs with CAR-T therapies.
- Fatal outcomes with TCEs increased from 14.3% in 2015 to 23.5% in 2025 (P<0.001).
- TCEs showed stronger signals for Infection and Tumor Lysis Syndrome (TLS), while CAR-T had stronger signals for Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).
- TLS and CRS occurred earlier with TCEs compared to CAR-T.
- Network analysis highlighted the co-occurrence and severity of the CRS-ICANS-infection triad.
- TCEs exhibited drug-specific toxicities, such as severe oral/nail toxicities with talquetamab and extramedullary relapse with blinatumomab.
- TCE-associated ICANS had a strong signal (ROR 197.08), with 26% fatal outcomes and early-peaking reporting patterns.
- Risk factors for TCE-associated ICANS included age, indication, target, and concurrent CRS.
- The study supports early monitoring and molecule-specific risk management for T-cell redirecting therapies.