Lisocabtagene maraleucel (Breyanzi; liso-cel) demonstrated real-world efficacy as a treatment for patients with relapsed/refractory mantle cell lymphoma (MCL), according to findings from a retrospective, observational study presented in a poster session at the European Hematology Association (EHA) 2026 Congress.
Among 118 patients treated with the CAR T product eligible for post-infusion assessment with available response data, the objective response rate (ORR) was 89% (95% CI, 82%-94%), with 79% (95% CI, 71%-86%) achieving a complete response (CR). The median duration of response (DOR) was not reached, with a 6-month DOR rate of 81% (95% CI, 66.5%-90%). Notably, a higher ORR was observed in this real-world cohort vs patients treated in the MCL cohort of the TRANSCEND NHL 001 trial (NCT02631044).2Moreover, the rates of response were similar among patients deemed ineligible for TRANSCEND MCL; the ORR was 86% (95% CI, 75%-93%), and the CR rate was 75% (95% CI, 63%-85%).
Furthermore, the median progression-free survival (PFS) was not reached in this population, with a 6-month rate of was 79% (95% CI, 70%-86%). The median overall survival (OS) was not reached, with a 6-month rate of 92% (95% CI, 85%-96%). A total of 12% of patients had died; the most common cause was disease progression (8%). Deaths resulted from pulmonary failure, septic shock, traumatic subdural hemorrhage, and a cause not provided in 1 patient each.
The 6-month non-relapse mortality (NRM) rate was 2% (95% CI, 0%-5.5%), and the 6-month cumulative incidence of relapse or progression was 19% (95% CI, 12%-27%).
“These early real-world results demonstrate that liso-cel achieves high response rates with signs of durable benefit in a broad population of patients with [relapsed/refractory] MCL, with outcomes consistent with the pivotal clinical trial,” presenting author Jennifer J. Huang, MD, PhD, assistant professor in the Division of Hematology and Oncology at the University of Washington School of Medicine and the Clinical Research Division of Fred Hutch Cancer Center, wrote in the presentation with study coinvestigators.1 “Liso-cel represents an important treatment option for patients with [relapsed/refractory] MCL, including patients with high-risk disease features who have limited treatment choices.”
Patients with relapsed/refractory MCL who received commercial liso-cel and had a minimum of 1 post-infusion safety and response assessment were eligible for inclusion in the real-world study. The study period spanned May 2024 to the data cutoff date of December 2, 2025.
The median age was 71 years (range, 46-85), with 72% of patients being 65 years and older. A total of 85% of patients were White, and 95% had an ECOG performance status of 0 to 1. Most patients had extranodal involvement prior to infusion (52%), received bridging therapy (72.5%), and had Ki-67–positive status at diagnosis (97.5%). The median number of prior therapy lines was 4 (range, 2-12); the most common treatments were covalent Bruton tyrosine kinase inhibitors (95%).
The assessed efficacy outcomes of the study were ORR, CR rate, time to response, DOR, PFS, and OS. Safety outcomes included the rate of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), clinically significant infections, cytopenia at day 30, and second primary malignancies.
The real-world safety was consistent with the safety observed in the TRANSCEND NHL 001 MCL cohort. CRS of any grade was observed among 65% of patients, with 2% experiencing grade 4 events and no grade 5 events observed.Moreover, the rate of ICANS was 36%, which included 14% of patients experiencing grade 3 or higher events; 1 grade 4 and 1 grade 5 event was observed across the real-world population. For the grade 5 ICANS event, the primary cause of death was reported as disease progression with ICANS noted as a contributing cause.
The median time from infusion to onset of CRS or ICANS was 4.0 days (IQR, 3.0-6.0) and 7.0 days (IQR, 5.0-9.5), respectively. The median duration of CRS and ICANS events was 3.0 days (95% CI, 2.0-5.0) and 4.5 days (2.0-8.5), respectively. A total of 48% of patients experiencing CRS received tocilizumab (Actemra) alone, and 43% of those experiencing ICANS received corticosteroids alone.
Other adverse effects (AEs) of special interest included cytopenia, with 17% of patients experiencing at least 1 event. The median time to platelet or neutrophil recovery was 47 days (range, 32-187). Moreover, clinically significant infections were observed in 24% of patients, with bacterial infections emerging as the most common (17%). A further 7% experienced second primary malignancies.
References
- Huang JJ, Brooks T, Romancik J, et al. Outcomes of lisocabtagene maraleucel (liso-cel) In patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL): first real-world data from the CIBMTR. Presented at: European Hematology Association 2026 Congress; June 11-14, 2026; Stockholm, Sweden. Abstract PF935.
- Wang M, Siddiqi T, Gordon LI, et al. Lisocabtagene maraleucel in relapsed/refractory mantle cell lymphoma: primary analysis of the mantle cell lymphoma cohort from TRANSCEND NHL 001, a phase I multicenter seamless design study. J Clin Oncol. 2024;42(10):1146-1157. doi:10.1200/JCO.23.02214
