Locke FL, Miklos DB, Jacobson CA, et al. - In patients with early relapsed or refractory large B-cell lymphoma after the receipt of first-line chemoimmunotherapy, administration of axicabtagene ciloleucel (axi-cel) therapy conferred significant improvements, than standard care, in event-free survival and response, with the expected level of high-grade toxic effects.

• In this international, phase 3 trial, patients with large B-cell lymphoma that was refractory to or had relapsed no more than 12 months after first-line chemoimmunotherapy were included.

• They were randomly assigned to receive axicabtagene ciloleucel (axi-cel, an autologous anti-CD19 chimeric antigen receptor T-cell therapy) (n=180) or standard care (n=179).

• In terms of event-free survival, axi-cel therapy was better than standard care; the 24-month event-free survival was 41% and 16% in the axi-cel group and standard-care group, respectively (hazard ratio for event or death, 0.40).

• An interim analysis revealed estimated overall survival, at 2 years, of 61% in the axi-cel group and 52% in the standard-care group.

• Occurrence of adverse events (of grade 3 or higher) was noted in 91% of the patients in the axi-cel group and in 83% of those who received standard care.

• No deaths associated with cytokine release syndrome or neurologic events occurred.