Multicenter phase 2 trial of axicabtagene ciloleucel plus rituximab for refractory large B cell lymphoma

CD19-negative relapse occurs in approximately 30% of patients with relapsed or refractory large B cell lymphoma (LBCL) who respond to axicabtagene ciloleucel (axi-cel; CD19-directed CAR T cell therapy). In the multicenter phase 2 ZUMA-14 trial in the USA, 26 patients with chemorefractory LBCL received axi-cel in combination with rituximab. The primary endpoint was investigator-assessed complete response rate. The complete response rate was 73%, with a median duration of response 26.0 months; 46% had an ongoing response at data cutoff. The median progression-free survival was 23.6 months (95% CI 3.4-NE) and median overall survival was not reached (25.8-NE). Peak CAR T cell (normalized by tumor burden) and rituximab area-under-the-curve levels were elevated in participants with complete or ongoing response. The authors conclude that dual targeting of CD19 and CD20 is a feasible and safe approach for chemorefractory LBCL.