For patients with refractory or relapsed large B-cell lymphoma, axicabtagene ciloleucel (axi-cel) leads to improvements in event-free survival and response compared with standard care, according to a study published online Dec. 11 in the New England Journal of Medicine and presented at the annual meeting of the American Society of Hematology, held from Dec. 11 to 14 in Atlanta.
Frederick L. Locke, M.D., from the H. Lee Moffitt Cancer Center in Tampa, Florida, and colleagues conducted a trial involving patients with large B-cell lymphoma that was refractory to or had relapsed no more than 12 months after first-line chemoimmunotherapy. Participants were randomly assigned to either axi-cel or standard care (two or three cycles of chemoimmunotherapy, followed by high-dose chemotherapy with autologous stem cell transplantation in those with a response to chemoimmunotherapy; 180 and 179 patients, respectively).
The researchers found that at a median follow-up of 24.9 months, median event-free survival was 8.3 and 2.0 months in the axi-cel and standard care groups, respectively; 24-month event-free survival was 41 and 16 percent, respectively (hazard ratio for event or death, 0.40). Overall, 83 and 50 percent of patients in the axi-cel and standard care groups, respectively, had a response, with complete response occurring in 65 and 32 percent, respectively. The estimated overall survival at two years was 61 and 52 percent in the axi-cel and standard care groups, respectively, in an interim analysis. Adverse events of grade 3 or higher occurred in 91 and 83 percent of those receiving axi-cel or standard care, respectively.
“We observed a clear improvement with axi-cel, as compared with standard care, in event-free survival and the percentage of patients with a response,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Kite Pharma, a Gilead Company, which manufactures axicabtagene ciloleucel and funded the study.