Retrospective study of real-world outcomes with tisagenlecleucel for aggressive B-cell lymphoma

Tisagenlecleucel (tisa-cel) is a CD19 CAR T-cell therapy approved for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) after two or more lines of therapy. Analysis of data in the Center for International Blood and Marrow Transplant Research registry evaluated efficacy and safety of tisa-cel for R/R DLBCL and R/R HGBCL in the real world. As of May 2022, 1159 patients received tisa-cel. The overall response rate was 59.9%, with complete response in 44.5%. With a median follow-up of 23.2 months in the efficacy set (n=968), the 24 months rates of progression-free survival, ongoing response, and overall survival were 28.4%, 52.6%, and 43.6%, respectively. Grade ≥ 3 cytokine release syndrome was reported in 6% of patients and grade ≥ 3 neurotoxicity in 7.4%. Patients with DLBCL (versus HGBCL), patients with complete repsonse, prior transplantation, and LDH within normal limits experienced more favorable efficacy outcomes, whereas those with ECOG performance status 2 or higher, 3 or more previous lines of therapy, elevated LDH, and fludarabine-based lymphodepletion experienced less favorable safety outcomes. The authors conclude that tisa-cel for R/R DLBCL and R/R HGBCL in the real world showed consistent efficacy and better safety outcomes than in the pivotal trial.