Real-World Analysis Reveals Liso-Cel Elicits High Response Rates in R/R Mantle Cell Lymphoma

A single infusion of the CD19-directed CAR T-cell therapy lisocabtagene maraleucel (liso-cel; Breyanzi) elicited responses with signals of durable benefit in a real-world cohort of patients with relapsed/refractory mantle cell lymphoma (MCL), according to data from a Center for International Blood and Marrow Transplant Research (CIBMTR) registry analysis presented at the 2026 EHA Congress.¹

Liso-cel elicited an objective response rate (ORR) of 89% (95% CI, 82%-94%) among the 121 patients with postinfusion assessment, with a complete response (CR) rate of 79% (95% CI, 71%-86%). Notably, response rates were comparable among the 53% of patients (n = 64) who would have been ineligible for TRANSCEND MCL (NCT02631044), with an ORR of 86% (95% CI, 75%-93%) and a CR rate of 75% (95% CI, 63%-85%).

At a median follow-up of 6 months (95% CI, 5.9-6.2), the median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were all not reached. The 6-month DOR rate was 81% (95% CI, 66.5%-90%), the 6-month PFS rate was 79% (95% CI, 70%-86%), and the 6-month OS rate was 92% (95% CI, 85%-96%).

“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, study authors, led by Jennifer J. Huang, MD, of Fred Hutchinson Cancer Center and the University of Washington in Seattle, wrote in the poster. “Liso-cel represents an important treatment option for [these] patients, including [those] with high-risk disease features who have limited treatment choices.”

Why do real-world liso-cel data matter for relapsed/refractory MCL?

The autologous, CD19-directed CAR T-cell product was FDA approved in May 2024 for use in adult patients with relapsed/refractory MCL who have previously received at least 2 lines of systemic therapy, including a BTK inhibitor.² The decision was supported by results from TRANSCEND-MCL (NCT02631044), which showed that liso-cel induced an ORR of 85.3% (95% CI, 74.6%-92.7%) and a CR rate of 67.6% (95% CI, 55.2%-78.5%). The median DOR was 13.3 months (95% CI, 6.0-23.3) after a median follow-up of 22.2 months (95% CI, 16.7-22.8).

At the time of the approval, Leo I. Gordon, MD, of Feinberg School of Medicine, Robert H. Lurie Cancer Center, further discussed the significance of the decision with OncLive^®:³

In November 2025, the European Commission also approved liso-cel for use in this patient population.⁴ This decision was also based on findings from the MCL cohort of TRANSCEND NHL 001. In terms of safety, it was reported that incidences of grade 3 or higher cytokine release syndrome (CRS) or neurologic events were low with liso-cel, at rates of 1% and 9%, respectively.¹

The present analysis represents the first report of real-world effectiveness and safety with liso-cel in R/R MCL, according to study authors.

How was the CIBMTR real-world liso-cel analysis designed?

The retrospective, observational study included patients in the United States with R/R MCL who received commercial liso-cel between May 2024 and December 2025; patients had at least 1 postinfusion assessment reported to the CIBMTR registry. The data cutoff date for the analysis was December 2, 2025.

Effectiveness outcomes comprised ORR, CR rate, time to response, DOR, PFS, and OS; safety end points included CRS, immune effector cell–associated neurotoxicity syndrome (ICANS), clinically significant infections, cytopenia at day 30, second primary malignancy, nonrelapse mortality (NRM), and deaths.

Of 160 patients infused with commercial liso-cel as available from the registry, 39 had no postinfusion assessment, leaving 121 patients in the analysis cohort; 3 patients did not have response data available, which left 118 patients evaluable for response.

The cohort reflected an older, comorbidity-burdened population. The median age at infusion was 71 years (range, 46-85), with 72% of patients aged 65 years or older, and 66% had at least 1 clinically significant comorbidity. Most patients (95%) had an ECOG performance status of 0 or 1. Disease was refractory in 68% of patients, 52% had extranodal involvement, 34% had elevated lactate dehydrogenase before infusion, and 72.5% received bridging therapy. Thirteen percent of patients had bulky disease. The median number of prior lines of therapy was 4 (range, 2-12); 98% had received a BTKi, 26% had received a BCL2 inhibitor, and 22% had undergone hematopoietic stem cell transplantation. Data on TP53 mutation status were limited; among those assessed, 17% (5/29) had a TP53 deletion at diagnosis by fluorescence in situ hybridization.

A substantial proportion of patients was infused in the outpatient setting; among the 47 outpatient-infused patients, 60% were subsequently hospitalized, with a median time to hospitalization of 5.5 days (range, 1-51) after infusion and a median hospital stay of 5 days (range, 1-32).

What did the safety analysis show with liso-cel in R/R MCL?

The safety profile was consistent with TRANSCEND MCL, with predominantly low-grade CRS and ICANS. CRS of any grade occurred in 65% of patients (n = 79) and was primarily grade 1 (45%) or grade 2 (18%); 2 patients (2%) had grade 4 CRS, and there were no grade 5 CRS events.

ICANS of any grade occurred in 36% of patients (n = 44), with grade 3 or higher events reported in 14% of patients. There was 1 patient with grade 5 ICANS whose primary cause of death was reported as disease persistence/progression, with ICANS as a contributing cause. The median time from infusion to onset of CRS and ICANS was 4 days (IQR, 3.0-6.0) and 7 days (IQR, 5.0-9.5), respectively; the median duration was 3.0 days (IQR, 2.0-5.0) and 4.5 days (IQR, 2.0-8.5), respectively.

The incidence of cytopenia at day 30 was low, at 17%, and the median time to platelet or neutrophil recovery was 47 days (range, 32-187). Clinically significant infections occurred in 24% of patients; bacterial infection was the most common (17%), followed by viral (9%), other (5%), and fungal (3%) infections. Second primary malignancies were reported in 7% of patients.

A total of 14 patients (12%) died, with most deaths attributable to disease persistence/progression (8%). The 6-month NRM rate was low, at 2% (95% CI, 0%-5.5%).

References

1. Huang JJ, Brooks T, Romancik J, et al. Outcomes of lisocabtagene maraleucel in patients with relapsed or refractory mantle cell lymphoma: first real-world data from the CIBMTR. Presented at: 2026 European Hematology Association Congress; June 11-14, 2026; Stockholm, Sweden. Abstract PF935.
2. FDA approves lisocabtagene maraleucel for relapsed or refractory mantle cell lymphoma. News release. FDA. May 30, 2024. Accessed June 15, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma
3. Gordon LI. Dr Gordon on the FDA approval of liso-cel in relapsed/refractory MCL. OncLive.com. May 30, 2024. Accessed June 15, 2026. https://www.onclive.com/view/dr-gordon-on-the-fda-approval-of-liso-cel-in-relapsed-refractory-mcl
4. Bristol Myers Squibb receives approval from the European Commission to expand use of CAR T cell therapy Breyanzi for relapsed or refractory mantle cell lymphoma. News release. Bristol Meyers Squibb. November 24, 2025. Accessed June 15, 2026. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Receives-Approval-from-the-European-Commission-to-Expand-Use-of-CAR-T-Cell-Therapy-Breyanzi-for-Relapsed-or-Refractory-Mantle-Cell-Lymphoma/default.aspx