Kite reports patient death in expansion cohort of ZUMA-1 trial

Kite Pharma Inc. (NASDAQ:KITE) said a patient died from treatment-related cerebral edema in an expansion cohort of the Phase I/II ZUMA-1 trial evaluating single IV infusions of axicabtagene ciloleucel (KTE-C19) to treat chemorefractory aggressive B cell non-Hodgkin's lymphoma (NHL). The patient had developed grade 3 cytokine release syndrome (CRS) and also had multi-organ failure.

On a conference call, Kite also said the patient had "explosive disease that was rapidly progressing" at the time of enrollment, with fever and signs of an underlying infection. Kite also said that the patient's underlying inflammatory condition was at an "extremely" high level, with the highest level of "certain cytokines" the company has seen among all ZUMA-1 patients. The company said it has informed FDA of the patient death and that all trials of the product will continue as planned...