Kite reports additional Phase I ZUMA-3 data of axicabtagene ciloleucel in ALL

Kite Pharma Inc. (NASDAQ:KITE) reported data from 11 evaluable patients with relapsed or refractory B precursor acute lymphoblastic leukemia (ALL) in the Phase I portion of the Phase I/II ZUMA-3 trial showing that axicabtagene ciloleucel (KTE-C19) led to complete remission or complete remission with incomplete or partial bone marrow recovery in 8 (73%) patients. The company said complete remissions were ongoing from 2 to >7.4 months. All responders tested negative for minimal residual disease (MRD). Patients received a single IV infusion of 1x10⁶ or 2x10⁶ axicabtagene ciloleucel cells/kg.

No dose-limiting toxicities (DLTs) were reported. There were 3 cases of grade ≥3 cytokine release syndrome (CRS) and 6 cases of grade ≥3 neurologic events. Kite said adverse events were "generally reversible." Data were presented at the American Society of Clinical Oncology meeting in Chicago. Kite previously reported preliminary data from the trial, including 1 death from treatment-related CRS (see BioCentury, Dec. 12, 2016)...