Background
Phase II, single-arm, multicenter study. 139 patients with R/R FL (grade 1–3a) after ≥2 prior lines including anti-CD20 and alkylating agent. Lisocabtagene maraleucel (liso-cel) is a CD19-targeted CAR-T with 4-1BB costimulatory domain and defined CD4:CD8 composition. TRANSCEND FL assessed liso-cel's efficacy and notably improved safety profile in FL.
Interventions and follow up
Regimen: Lisocabtagene maraleucel (liso-cel) 100 × 10⁶ CAR-T cells IV single infusion after fludarabine/cyclophosphamide lymphodepletion in R/R follicular lymphoma
Primary endpoint: Complete response rate (independent review committee)
mFollow up: ~16.8 months
Primary endpoint: Complete response rate (independent review committee)
mFollow up: ~16.8 months
Results
CR rate (primary): 73.4% (95% CI 64.8–80.8%)
ORR: 95.7%
1-year remission rate (among CRs): 81%
12-month PFS rate: 70.2%
mDOR: Not reached
ORR: 95.7%
1-year remission rate (among CRs): 81%
12-month PFS rate: 70.2%
mDOR: Not reached
Adverse events
CRS/neurologic: CRS any grade 60.4%, grade ≥3 1.4%; neurological events any grade 11.5%, grade ≥3 2.2%; no treatment-related deaths from CRS
Hematologic: Grade ≥3 neutropenia 37.4%, thrombocytopenia 21.6%; minimal grade ≥3 CRS distinguishes liso-cel from axi-cel in FL
Hematologic: Grade ≥3 neutropenia 37.4%, thrombocytopenia 21.6%; minimal grade ≥3 CRS distinguishes liso-cel from axi-cel in FL
Conclusions
Liso-cel achieved a 73.4% CR rate and 95.7% ORR in R/R FL with a markedly improved safety profile — grade ≥3 CRS only 1.4% compared to 7% with axi-cel — confirming liso-cel as the best-tolerated CAR-T option in FL.
Key Limitations
Single-arm Phase II without a randomized comparator. Follow-up (16.8 months) is relatively short for an indolent disease, so durability and curative fraction remain to be confirmed. mDOR not reached precludes firm estimates of long-term benefit. No head-to-head comparison with axi-cel (ZUMA-5) or bispecific antibodies; cross-trial safety comparisons are confounded by differing populations and lymphodepletion.
Clinical Context
TRANSCEND FL supported FDA approval of liso-cel for R/R FL after ≥2 prior lines (May 2024). Its very low grade ≥3 CRS (1.4%) and neurotoxicity (2.2%) make liso-cel the most favorably tolerated CD19 CAR-T in FL and a candidate for outpatient administration. ESMO recognizes CD19 CAR-T as an option in multiply relapsed FL. Choice among liso-cel, axi-cel, and bispecifics (mosunetuzumab, epcoritamab) depends on toxicity tolerance, logistics, and prior exposure.