ELARA

Follicular lymphoma relapses repeatedly and each remission tends to be shorter than the last, so the group that has exhausted antibodies, chemotherapy and often a transplant has needed something that does not depend on chemotherapy sensitivity. ELARA is the multinational phase 2 study of tisagenlecleucel in that group.

Of 98 enrolled patients, 97 received the product. In the 94-patient efficacy set, the complete response rate, the primary endpoint, 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), at a median follow-up of 16.6 months. Within eight weeks of infusion, 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. There were no treatment-related deaths.

The absence of severe cytokine release syndrome is what separates this from the aggressive-lymphoma CAR-T experience and is why the treatment can be given in centres that would not attempt it in diffuse large B-cell lymphoma. ELARA, ZUMA-5 and the bispecific antibody trials together mean that early-progressing follicular lymphoma now has three chemotherapy-free options.