Bishop MR, Dickinson M, Purtill D, et al. - Tisagenlecleucel is not better than standard salvage therapy for patients with aggressive lymphoma that was refractory to or progressing within 12 months after first-line therapy.

• In this international phase 3 trial, a total of 322 aggressive lymphoma patients refractory to or progressing within 12 months after first-line therapy were randomized to receive tisagenlecleucel with optional bridging therapy (tisagenlecleucel group) or salvage chemotherapy and autologous hematopoietic stem-cell transplantation (standard-care group).

• Lymphoma progression at week 6 was evident in 25.9% of the patients in the tisagenlecleucel group vs in 13.8% of those in the standard-care group.

• Both groups showed a median event-free survival of 3.0 months (hazard ratio for event or death in the tisagenlecleucel group, 1.07).

• In the tisagenlecleucel group, a response occurred in 46.3%, vs in 42.5% in the standard-care group.

• Deaths due to adverse events occurred in ten patients in the tisagenlecleucel group and 13 in the standard-care group.