Liso-cel (CD19 CAR-T) Delivers 100% CR/ORR With Minimal CRS/Neurotoxicity in Japanese R/R FL

Lisocabtagene maraleucel (liso-cel) is an autologous CD19-directed CAR-T cell therapy evaluated in the Japanese subgroup of the Phase 2 TRANSCEND FL study (NCT04245839) in second-line or later relapsed/refractory follicular lymphoma after anti-CD20– and alkylator-containing therapy. Among 10 treated patients (9 efficacy-evaluable; median age 67; median 3 prior lines), IRC-assessed ORR and CR were both 100% (95% CI 66.4–100); median DOR and PFS were not reached with 24-month DOR and PFS rates both 88.9% (only 1 relapse) and OS 100% at a median 31-month follow-up. Safety looked unusually clean for CAR-T (any-grade CRS 30%, neurologic events 10%, infections 30%; no grade ≥3 CRS/NEs/infections) versus the other approved CAR-T benchmark in R/R FL, axi-cel in ZUMA-5 (ORR ~94%, CR ~79%, but grade ≥3 CRS ~6% and grade ≥3 neurologic AEs ~15%).