Myocarditis occurrence with cancer immunotherapy across indications in clinical trial and post-marketing data.

ABSTRACT: Antibodies targeting the PD-1, PD-L1, and CTLA-4 immune checkpoint axis have been used in a variety of tumor types. They achieve anti-tumor activity through activating the patient's own immune system to target immune response evading cancer cells. However, this unique mechanism of action may cause immune-related adverse events, irAEs. One of these irAEs is myocarditis which is associated with an alarming mortality rate. In this study we presented clinical cases of myocarditis from safety trial datasets submitted to the U.S. Food and Drug Administration, FDA. Additionally, we analyzed over fourteen million FDA Adverse Event Reporting System, FAERS, submissions. The statistical analysis of the FAERS data provided evidence of significantly increased reporting of myocarditis in patients admini

SUBMITTER: Makunts T 

PROVIDER: S-EPMC8405813 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature