ADVERTISEMENT
Tisagenlecleucel Shows Similar Effects to Standard Care for DLBCL
Second-line tisagenlecleucel, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved for diffuse large B-cell lymphoma (DLBCL) after at least 2 treatment lines, was found to not be superior to standard care, according to findings from a phase 3 trial.
“Patient outcomes are poor for aggressive B-cell non-Hodgkin’s lymphomas (NHLs) not responding to or progressing within 12 months after first-line therapy,” explained Michael R. Bishop, MD, University of Chicago Comprehensive Cancer Center, and co-researchers.
The researchers conducted an international phase 3 trial which enrolled a total of 322 patients with aggressive lymphoma who were refractory to or progressing within 12 months after first-line therapy. Patients were either assigned to tisagenlecleucel with optional bridging therapy or salvage chemotherapy and autologous hematopoietic stem-cell transplantation (HSCT, standard-care group).
The primary endpoint was event-free survival (EFS) with secondary endpoints being response and safety.
“The median time from leukapheresis to tisagenlecleucel infusion was 52 days. A total of 25.9% of the patients in the tisagenlecleucel group had lymphoma progression at week 6, as compared with 13.8% of those in the standard-care group,” reported Dr Bishop and co-authors.
Further, in both groups the median EFS was 3 months (HR 1.07; 95% CI, 0.82-1.40; P = 0.61). The researchers reported a response occurred in 46.3% of the patients in the tisagenlecleucel group and in 42.5% in the standard-care group, respectively.
“Tisagenlecleucel was not superior to standard salvage therapy in this trial. Additional studies are needed to assess which patients may obtain the most benefit from each approach,” concluded Dr Bishop, et al.—Alexa Stoia
