Lisocabtagene Maraleucel 治疗复发/难治性弥漫大 B 细胞淋巴瘤：证据何在？

Lisocabtagene maraleucel (liso-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T cell product, with a CD3 activatory domain connected to 4-1BB costimulatory domain. Liso-cel, unlike the other two approved products-axicabtagene ciloleucel and tisagenlecleucel-is manufactured separately from CD4 and CD8 T cells and then administered as a sequential infusion of the two components at equal target doses. The approval of liso-cel was based on the results of Transcend NHL 001, a single-arm, open-label, multicenter, seamless design trial that enrolled 344 patients, of whom 269 received conforming liso-cel. The most common histology was diffuse large B cell lymphoma, not otherwise specified (DLBCL NOS; n = 137, 51%) followed by DLBCL transformed from indolent lymphomas (n = 78, 29%).

Encouraging results were reported, yielding an objective response rate across all dose levels of 73% [complete remission (CR) = 53%], with an estimated duration of response at 1 year of 55% for all patients and 65% for those achieving a CR. The estimated 12-month overall survival was 58% for all patients and 86% for those achieving a CR.

Cytokine release syndrome and neurological adverse events were reported in 42% and 30%, respectively. This review summarizes the evidence on the safety and effectiveness of liso-cel, resulting in its addition to the current treatment armamentarium of relapsed or refractory large B cell lymphoma.