A study of the standard-of-care use of axicabtagene ciloelucal (axi-cel) chimeric antigen receptor T-cell (CAR-T) therapy for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) has revealed favorable outcomes similar to those seen in the ZUMA-1 registrational trial on the treatment.1
The treatment was studied retrospectively in 298 patients with relapsed or refractory DLBCL who underwent leukapheresis at 1 of 17 US institutions with the intent of undergoing treatment with axi-cel.
Of the included patients, 43% would not have met eligibility criteria for the ZUMA-1 trial because of comorbidities at the time of leukapheresis. Despite this, safety and efficacy was similar in this standard-of-care group of patients.
The majority of patients (92%) received axi-cel therapy. The best overall response rate in infused patients was 82%, and the best complete response rate was 64%.
With a median follow-up of 12.9 months, median progression-free survival was 8.3 months. Median overall survival was not reached.
Grade 3 or worse cytokine release syndrome occurred in 7% of patients. In the ZUMA-1 trial, the rate of cytokine release syndrome was 11%. The nonrelapse mortality was 4.4% compared with 3.7% in the ZUMA-1 trial. Neurotoxicity occurred at a similar rate as seen in ZUMA-1.
“Our study shows that delivery of axi-cel therapy is feasible outside clinical trials,” the researchers wrote. “Overall, our study demonstrates that the overall safety and efficacy of axi-cel in the SOC setting is comparable to what was observed on the pivotal ZUMA-1 trial, despite the observation that many patients would not have met eligibility criteria for the pivotal trial because of comorbidities.”
Nastoupil LJ, Jain MD, Feng L, et al. Standard-of-care axicabtagene ciloleucel for relapsed or refractory large B-cell lymphoma: Results from the US Lymphoma CAR T Consortium [published online May 13, 2020]. J Clin Oncol. doi: 10.12