Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma.

Abstract (PubMed)

In a phase 1 trial, axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, showed efficacy in patients with refractory large B-cell lymphoma after failure of conventional therapy. In this multicenter, phase 2 trial, we enrolled 111 patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, or transformed follicular lymphoma. All had refractory disease after at least two lines of therapy. Patients received axi-cel at a target dose of 2×10^6 CAR T cells per kilogram of body weight. The primary end point was the objective response rate. The objective response rate was 82%, with 54% of patients having a complete response. At a median follow-up of 15.4 months, 42% of patients had an ongoing response. Grade 3 or higher cytokine release syndrome and neurologic events occurred in 13% and 28% of patients, respectively.