Adverse effects and non-relapse mortality of BCMA directed T cell therapies in multiple myeloma: an FAERS database study
Zimu Gong, Godsfavour Umoru, Jorge Monge, Nishi Shah, Ghulam Rehman Mohyuddin, Sabarinath Venniyil Radhakrishnan, Rajshekhar Chakraborty, Leo Rasche, Carolina Schinke, Anita D’Souza, Meera Mohan
Abstract
B-cell maturation antigen (BCMA)-directed T cell therapies such as idecabtagene vicleucel (ide-cel), ciltacabtagene autoleucel (cilta-cel), teclistamab, and elranatamab have changed the therapeutic landscape of patients with relapsed/refractory multiple myeloma (MM) [ 1 , 2 , 3 , 4 ]. Despite their effectiveness, chimeric antigen receptor (CAR) T-cell and bispecific antibody (bsAb) therapies have distinct toxicity profiles, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), non-ICANS neurotoxicity, and the risk of infections, all contributing to significant morbidity and potentially non-relapse mortality (NRM) [ 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 ]. However, there is substantial variability in attributing treated-related adverse effects and mortality to the therapy in the pivotal registration clinical trials [ 12 ]. The U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database contains reports of adverse events, medication error, and product quality complaints that were submitted to the FDA. Although healthcare providers and consumers voluntarily contribute to the data source, drug manufacturers are obligated to provide mandatory reporting. Herein, we analyzed the most reported adverse events and NRM among the FDA-approved BCMA-directed immunotherapy in MM.