Real-world outcomes and toxicities of CAR-T in relapsed/refractory follicular lymphoma: a multicenter cohort study

Chimeric antigen receptor T-cell therapy has revolutionized the treatment of relapsed/refractory (R/R) follicular lymphoma (FL). Real-world efficacy and toxicity data are needed because clinical trial populations are often unrepresentative. Therefore, we conducted a multicenter retrospective study of R/R FL patients undergoing commercial axicabtagene ciloleucel (axi-cel) or tisagenlecleucel (tisa-cel) between 2021 and 2024. End points included efficacy measures (overall response rate [ORR], complete response rate [CRR], progression-free survival [PFS], and overall survival [OS]) and toxicity (rates of cytokine release syndrome [CRS] and immune effector cell-associated neurotoxicity syndrome [ICANS]). Among 136 patients, 100 (74%) received axi-cel and 36 (26%) received tisa-cel. Axi-cel patients were younger than tisa-cel patients (median age, 60 vs 68 years; P = .001) and received bendamustine lymphodepletion less often than them (9% vs 33%; P< .001). Median follow-up was 14.4 months (range, 0.8-72.0 months). In the unweighted analysis, compared with tisa-cel, axi-cel was associated with higher ORR (96% vs 80%; P = .007), CRR (88% vs 71%; P = .024), and longer median PFS (30.5 months vs 11.9 months; P = .021). Median OS did not differ significantly between the 2 products (not reached vs 23.6 months; P = .061). The rates of CRS were comparable (75% vs 75%; P = .99), whereas ICANS occurred more frequently with axi-cel than with tisa-cel (42% vs 17%; P = .008). After inverse probability of treatment weighting, efficacy outcomes were largely similar, but axi-cel remained associated with significantly higher toxicity. In real-world settings, both axi-cel and tisa-cel demonstrated efficacy in patients with R/R FL, although PFS was inferior to that reported in clinical trials.