Kite Pharma's shares plunged on May 8 after news spread that a patient in a safety study testing a chimeric antigen receptor (CAR)-T cell therapy to treat non-Hodgkin's lymphoma (NHL) had died. The patient in the phase 2 ZUMA-1 study testing axicabtagene ciloleucel (KTE-19) developed fatal cerebral edema, a situation resembling a setback experienced last year by rival CAR-T cell therapy developer Juno, when five patients treated with its candidate product JCAR015, a CD19- targeted CAR-T product for treating relapsed refractory acute lymphoblastic leukemia (Nat. Biotechnol. 35, 6–7, 2017), died. The deaths led Juno to drop the program. Investors may have been rattled by Kite's news, because there are similarities between the two treatments: both Kite's KTE-19 and JCAR015 target CD19 and use the CD28 co-stimulatory domain. Kite has informed the US Food and Drug Administration of the event and all studies of the candidate drug will continue as planned. Kite's chief medical officer David Chang said the patient had “explosive disease and was rapidly progressing” at the time of enrollment, and that this was the only death in 300 patients treated with KTE-19. In March, Kite completed a Biologics License Application for this therapy in relapsed or refractory aggressive NHL. Basel, Switzerland–based Novartis also submitted a biologics license application under priority review for another CD19-targeting CAR-T cell therapy, tisagenlecleucel-T (CTL019) to treat relapsed and refractory B-cell acute lymphoblastic leukemia.
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