High 3-year efficacy and favourable safety of liso-cel in 3L+ FL

After 3 years of follow-up, results from the TRANSCEND FL study confirm the high efficacy and sustained favourable safety profile of lisocabtagene maraleucel (liso-cel) in patients with third-line or later relapsed/refractory follicular lymphoma (3L+ R/R FL). A single infusion resulted in high rates of deep and durable responses, as well as favourable survival outcomes, regardless of early progression after first-line chemoimmunotherapy (POD24) or prior exposure to bendamustine [1].

Liso-cel is a CD19-directed CAR T-cell therapy that has demonstrated favourable efficacy with a manageable safety profile across B-cell malignancies. In the primary analysis of the open-label phase 2 TRANSCEND FL study (NCT04245839), liso-cel achieved an overall response rate (ORR) of 97% with a favourable safety profile in patients with R/R FL [2]. Prof. Alejandro Martín García-Sancho (University of Salamanca, Spain) presented 3-year follow-up results for patients with 3L+ FL from the TRANSCEND FL trial [1].

In total, 107 patients were evaluable for safety and 103 for efficacy. The median age was 62 years (range 23–80); 95 patients (89%) had Ann Arbor stage III/IV disease, and 61 (57%) had high-risk disease per FL International Prognostic Index.

Three-year response rates were consistent with the primary analysis, as noted by Prof. García-Sancho. The ORR was 97% (95% CI 92–99%); the complete response rate (CRR) was 94% (95% CI 88–98%). The median duration of response was not reached; 70% of patients (95% CI, 60–78%) remained in response at 3 years.

Subgroup analyses demonstrated an ORR exceeding 95% in patients with high-risk features, including POD24, bulky disease, and double-refractory disease. Patients who received bendamustine ≥12 months prior to leukapheresis showed durable responses and high 3-year progression-free survival rates, comparable to the overall population.

Long-term safety analyses confirmed a favourable long-term safety profile for liso-cel, with no new signals identified. Grade ≥3 neutropenia and hypogammaglobulinaemia decreased over time, and the rate of severe infection remained low. These findings support the feasibility of outpatient management and suggest a potential for reduced healthcare resource utilisation with liso-cel in clinical practice.

Dreyling M, et al. Three-year efficacy and longitudinal safety of lisocabtagene maraleucel (liso-cel) in patients with third-line or later (3l+) follicular lymphoma (fl) from TRANSCEND FL. OS02-02, EBMT congress 2026, 22–25 March, Madrid, Spain.
Morschhauser F, et al. Nat Med. 2024;30(8):2199-2207.