Positive results have been reported from a pivotal analysis of axicabtagene ciloleucel (Kite Pharmaceuticals), a chimeric antigen receptor T-cell (CAR-T) therapy candidate, in 101 patients with chemorefractory, aggressive B-cell non-Hodgkin’s lymphoma (NHL). The study met its primary endpoint, with an 82% objective response rate (complete response [49%] + partial response [33%]) after a single infusion of axicabtagene ciloleucel (P < 0.0001).
With a median follow-up of 8.7 months, median overall survival has not yet been reached.
The most common grade 3 or higher adverse events included anemia (43%), neutropenia (39%), decreased neutrophil count (32%), febrile neutropenia (31%), decreased white blood cell count (29%), thrombocytopenia (24%), encephalopathy (21%), and decreased lymphocyte count (20%).
There were three deaths that were not due to disease progression. Two events, one hemophagocytic lymphohistiocytosis and one cardiac arrest in the setting of cardiorenal syndrome, were deemed to be related to axicabtagene ciloleucel. The third case, a pulmonary embolism, was deemed to be unrelated. Between the interim analysis, which included 62 patients, and the primary analysis, which included 101 patients, there were no additional deaths due to adverse events.
Kite Pharmaceuticals plans to seek FDA approval of axicabtagene ciloleucel for patients with aggressive NHL based on the combined data from all 101 patients and plans to complete its rolling submission of a biologics license application by the end of the first quarter of 2017.
Source: Kite Pharmaceuticals; February 28, 2017.