David Miklos, MD, PhD, describes the toxicity profile of KTE-X19, a chimeric antigen receptor T-cell therapy, in the ZUMA-2 trial.
David Miklos, MD, PhD, clinical director of the Chimeric Antigen Receptor (CAR) T-Cell Therapy Program and associate professor of Medicine at the Stanford University Medical Center, describes the toxicity profile of KTE-X19, a CAR T-cell therapy, in the ZUMA-2 trial.
Miklos explains the importance of the adverse events (AEs) seen in the ZUMA-2 trial compared with those seen in the ZUMA-1 trial. KTE-X19 is associated with 3 known toxicities, which are challenging when managing patients receiving CAR T cells, according to Miklos. These include cytokine release syndrome (CRS), neurotoxicity, and cytopenias delayed in the 28-day period. These AEs were not any worse than what has been seen previously with this drug. Grade ≥3 neurotoxicity was observed in about 30% of patients, and grade 2 CRS was seen in at least 50% of patients with mantle cell lymphoma being studied for this trial. About 50% of patients had cytopenias and low blood counts after a ≥28-day period.
Miklos believes that a CAR T center with experience with KTE-X19 will be able to manage these toxicities, but this therapy will require inpatient treatment and the care of a full oncology team at an experienced cancer center for patients on this regimen to have similar outcomes seen on the ZUMA-2 trial.