Results from the global, phase III TRANSFORM study support lisocabtagene maraleucel (liso-cel) as a new second-line treatment recommendation in patients with early relapsed or refractory large B-cell lymphoma (LBCL).
The study was conducted in 47 sites in the United States, Europe, and Japan and compared liso-cel, an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy, with standard of care as second-line therapy in 184 patients aged 18 to 75 years with primary refractory or early (≤12 months) relapsed LBCL.
Criteria for inclusion in the study included an Eastern Cooperative Oncology Group performance status score of 0 or 1, adequate organ function, positron emission tomography–positive disease per Lugano 2014 criteria, and candidacy for autologous hematopoietic stem cell transplantation (AHSCT).
Patients were randomized 1:1 to receive liso-cel (100 × 106 CAR+ T-cells intravenously) or standard of care, which consisted of three cycles of salvage immunochemotherapy (rituximab, dexamethasone, cytarabine, and cisplatin [R-DHAP]; rituximab, ifosfamide, carboplatin, and etoposide [R-ICE]; or rituximab, gemcitabine, dexamethasone, and cisplatin [R-GDP]) delivered intravenously followed by high-dose chemotherapy and AHSCT in responders.
At data cutoff, the median follow-up was 6.2 months. The median event-free survival, which was the study’s primary endpoint, was significantly improved in the liso-cel group (10.1 months) compared with the standard-of-care group (2.3 months; stratified hazard ratio, 0.35; 95% CI, 0.23-0.53; stratified Cox proportional hazards model one-sided P<.0001).
Previous research had demonstrated the efficacy and manageable safety of liso-cel in third-line or later LBCL.
Kamdar M, Solomon SR, Arnason J, et al. lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022;399(10343):2294-2308. doi:10.1016/S0140-6736(22)00662-6