The manufacturer of the investigational chimeric antigen receptor (CAR) T-cell therapy KTE-C19 reported that one patient enrolled in the safety expansion phase of the ZUMA-1 trial died from cerebral edema. The patient, who had refractory non-Hodgkin lymphoma (NHL), died in April. The FDA was notified, but the study was not placed on any clinical hold, according to Kite Pharmaceuticals, the drug’s manufacturer.
This is the first death from cerebral edema recorded in the KTE-C19 clinical trials program. In April, Kite Pharmaceuticals submitted a biologics license application to the FDA for KTE-C19 (also called axicabtagene ciloleucel) for the treatment of patients with aggressive NHL who cannot undergo hematopoietic cell transplantation, based on data from the ZUMA-1 trial. Three other deaths unrelated to disease progression have been recorded in the primary analysis of the ZUMA-1 trial; two were judged to be treatment-related and none involved cerebral edema.
However, earlier this year, development of another experimental CAR T-cell therapy (JCAR015) was discontinued after five patients with acute lymphocytic leukemia died from cerebral edema. The manufacturer, Juno Therapeutics, said its internal investigation identified multiple factors that increased the risk of severe toxic reactions among JCAR015-treated patients, including “factors related to the product.”
Source: TheStreet.com, May 8, 2017.