Infectious events in patients treated with immune checkpoint inhibitors, chimeric antigen receptor T cells and Bi-specific T-cell engagers: a review of registration studies

Background: Immunological treatments (immune checkpoint inhibitors, chimeric antigen receptor T cells, Bi-specific T-cell engagers) have deeply changed the treatment of several cancers. However, the impact of these treatments on the risk of developing infections has not been completely ascertained, yet. Methods: We reviewed all the registration studies of currently approved immune checkpoint inhibitors (ICIs), chimeric antigen receptor T cells (CAR-T cells) and Bi-specific T-cell engagers (BiTEs) to collect all the reported infections. For each drug, we have generated a report with the infections occurring in at least 10% of the patients enrolled. Results: The most frequently reported infections involving ICIs-treated patients involved the respiratory tract, including nasopharyngitis, upper respiratory tract infections and pneumonia, and the urinary tract. Among those treated with CAR-T cells, were frequently reported the incidence of unspecified infections and infestations, bacterial and viral infections. In patients treated with BiTEs, nasopharyngitis, pneumonia and device-related infections were the most frequently reported conditions. Conclusions: A wide range of infections are reported in registration studies and clinical trials of ICIs, CAR-T cells and BiTEs.