December 1, 2018 | Stephen J. Schuster, M.D., Michael R. Bishop, M.D., Constantine S. Tam, M.D., Edmund K. Waller, M.D., Ph.D., Peter Borchmann, M.D., Joseph P. McGuirk, D.O., Ulrich Jäger, M.D., Samantha Jaglowski, M.D., Charalambos Andreadis, M.D., Jason R. Westin, M.D., Isabelle Fleury, M.D., Veronika Bachanova, M.D., Ph.D., S. Ronan Foley, M.D., P. Joy Ho, M.B., B.S., D.Phil., Stephan Mielke, M.D., John M. Magenau, M.D., Harald Holte, M.D., Ph.D., Serafino Pantano, Ph.D., Lida B. Pacaud, M.D., Rakesh Awasthi, Ph.D., Jufen Chu, Ph.D., Özlem Anak, M.D., Gilles Salles, M.D., Ph.D., and Richard T. Maziarz, M.D., for the JULIET Investigators
The study evaluated the efficacy and safety of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy, in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The primary endpoint was the best overall response rate, which was 52% (95% CI, 41 to 62) among 93 patients with a median follow-up of 14 months. The response rates were consistent across prognostic subgroups, and durable responses were observed for up to 2 years. The most common grade 3 or 4 adverse events included cytokine release syndrome (22%), neurologic events (12%), cytopenias lasting more than 28 days (32%), infections (20%), and febrile neutropenia (14%). No deaths were attributed to tisagenlecleucel, cytokine release syndrome, or cerebral edema. The study demonstrated high and durable response rates, suggesting that tisagenlecleucel has the potential to improve outcomes in patients with relapsed or refractory DLBCL. However, further analysis is needed to assess long-term toxic effects and the potential for B-cell and immunoglobulin recovery.The study evaluated the efficacy and safety of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy, in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The primary endpoint was the best overall response rate, which was 52% (95% CI, 41 to 62) among 93 patients with a median follow-up of 14 months. The response rates were consistent across prognostic subgroups, and durable responses were observed for up to 2 years. The most common grade 3 or 4 adverse events included cytokine release syndrome (22%), neurologic events (12%), cytopenias lasting more than 28 days (32%), infections (20%), and febrile neutropenia (14%). No deaths were attributed to tisagenlecleucel, cytokine release syndrome, or cerebral edema. The study demonstrated high and durable response rates, suggesting that tisagenlecleucel has the potential to improve outcomes in patients with relapsed or refractory DLBCL. However, further analysis is needed to assess long-term toxic effects and the potential for B-cell and immunoglobulin recovery.