Discussion
EVENTS
ELARA is a phase 2, multicenter, global, pivotal trial of tisagenlecleucel, a second-generation anti-CD19 CAR-T therapy [Tisagenlecleucel demonstrated high rates of durable response, with a CRR of 100% in Japanese patients compared with the overall study population (Based on safety data reported in the global ELARA and ZUMA-5 trials, tisagenlecleucel (grade ≥ 3 CRS/neurological events: 0%/3% in the ELARA trial) could potentially be more tolerable than axicabtagene ciloleucel (grade ≥ 3 CRS/neurological events: 7%/19% in the ZUMA-5 trial), in this patient setting [Based on the transgene-time profiles and cellular kinetic parameters, cellular kinetics in Japanese patients were similar to those observed in the whole study population, suggesting ethnic insensitivity [This report has some limitations to consider when interpreting the results. The analysis has a limited number of patients (In summary, the results from the ELARA Japanese subset analysis of tisagenlecleucel showed high efficacy and a manageable safety profile in adult patients with r/r FL after ≥ 2 prior lines of therapy. The clinical outcomes in this subset analysis were promising (despite the limited number of patients) and are consistent with those of the overall ELARA study population. Tisagenlecleucel could offer a potential new treatment option for adult Japanese patients with r/r FL.
