Multicenter phase 2 trial of axicabtagene ciloleucel for large B cell lymphoma in patients ineligible for autologous stem cell transplantation

The multicenter phase 2 ALYCANTE trial in France evaluated axicabtagene ciloleucel (axi-cel) as second line therapy for relapsed or refractory large B cell lymphoma (R/R LBCL) in patients ineligible for autologous stem cell transplantation (autoSCT). The study met its primary endpoint with a complete metabolic response of 71.0% (95% CI 58.1-81.8) at 3 months from axi-cell infusion. The median follow-up was 12.0 months (range 2.1-17.9). The figure shows survival outcomes and duration of response. There was no unexpected toxicity. Grade 3-4 cytokine release syndrome and neurologic events occurred in 8.1% and 14.5% of patients, respectively. The authors conclude that these results support axi-cel as second-line therapy for R/R LBCL in patients ineligible for autoSCT.