Clinical Activity of TG-1701, As Monotherapy and in Combination with Ublituximab and Umbralisib (U2), in Patients with B-Cell Malignancies

The phase 2 ZUMA-12 trial evaluated axicabtagene ciloleucel as part of first-line therapy in patients with high-risk large B-cell lymphoma (Abstract 405). After leukapheresis and optional bridging therapy, patients received conditioning chemotherapy followed by a single infusion of CAR T cells (2 x 106/kg). The median age of the 32 evaluable patients was 61 years (range, 23-86), and 88% of the patients had stage 3/4 disease. After a median follow-up of 9.3 months (range, 0.9-18.0), the ORR was 85% (23/27), with a CR rate of 75%. The median DOR, median PFS, and median OS were not reached. The most common AEs of grade 3 or higher that were related to axicabtagene ciloleucel included encephalopathy (16%), decreased neutrophil count (9%), and increased alanine transaminase (9%). Grade 3 cytokine release syndrome developed in 3 patients (9%); no grade 4/5 cases occurred. Grade 3/4 neurologic events occurred in 8 patients (25%).