Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial

The primary prespecified interim analysis of a multinational phase 2 trial of tisagenlecleucel in adults with relapsed or refractory follicular lymphoma after two or more treatment lines, or relapsing after autologous stem-cell transplantation. The primary endpoint was the complete response rate.

At the 29 March 2021 data cut-off, 97 of 98 enrolled patients had received tisagenlecleucel, at a median follow-up of 16.59 months (interquartile range 13.8 to 20.21). The primary endpoint was met: in the 94-patient efficacy set the complete response rate was 69.1 per cent (95 per cent confidence interval 58.8 to 78.3) and the overall response rate 86.2 per cent (77.5 to 92.4). Within eight weeks of infusion, in the 97-patient safety set, cytokine release syndrome occurred in 48.5 per cent with no grade 3 or worse case, neurological events in 37.1 per cent with 3 per cent grade 3 or worse, and immune effector cell-associated neurotoxicity syndrome in 4.1 per cent with 1 per cent grade 3 or worse. There were no treatment-related deaths.