Liso-Cel Demonstrates Deep, Durable Responses in R/R Marginal Zone Lymphoma
Lisocabtagene maraleucel led to promising responses in relapsed/refractory marginal zone lymphoma, offering a new option with manageable safety.
Lymphoma: © David A Litman - www.stock.adobe.com
Data presented from the marginal zone lymphoma (MZL) cohort of the TRANSCEND FL trial (NCT04245839) demonstrated high rates of durable responses with the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (liso-cel; Breyanzi) in patients with relapsed or refractory MZL. These findings, unveiled at the 2025 International Conference on Malignant Lymphoma, indicate a potential new therapeutic option for this often-relapsing indolent non-Hodgkin lymphoma.1
The primary analysis of the MZL cohort of TRANSCEND FL, a phase 2, single-arm study, revealed an overall response rate (ORR) of 95.5% (95% CI, 87.3%-99.1%; 1-sided P <.0001) among 66 efficacy-evaluable patients. A complete response (CR) was achieved in 62.1% of patients (95% CI, 49.3%-73.8%; 1-sided P<.0001). At a median follow-up ranging from 21.6 to 24.5 months, the 24-month duration of response rate was 88.6%, the progression-free survival rate was 85.7%, and the overall survival rate was 90.4%.
These results underscore the sustained clinical benefit of this CD19-directed CAR T-cell therapy in a patient population with limited treatment options following relapse.
“Liso-cel achieved high, lasting response rates in patients with relapsed or refractory marginal zone lymphoma, underscoring the potential of this one-time therapy to significantly improve patient outcomes,” said M. Lia Palomba, MD, TRANSCEND FL study investigator and lymphoma and cell therapy specialist at Memorial Sloan Kettering Cancer Center, in a press release. “Currently, the median survival for patients with marginal zone lymphoma with multiple relapses is 3 to 5 years, signifying an urgent need for transformative therapies that can effectively address this hard-to-treat disease.”
The safety profile observed for liso-cel in the MZL cohort was consistent with prior findings for the therapy across other lymphoma types, with no new safety signals identified. The rates of severe cytokine release syndrome (CRS) and neurologic events (NE) were low. Any-grade CRS occurred in 76% of patients, with grade 3 CRS reported in 4% of patients, and there were no reports of grade 4/5 CRS. Any-grade NEs were observed in 33% of patients, with grade 3 NEs occurring in 4% of patients, and no grade 4/5 NEs reported.
As with other CAR T-cell therapies, a Risk Evaluation and Mitigation Strategy (REMS) program is in place to manage potential serious adverse events such as CRS and neurologic toxicities, and patients are monitored for at least four weeks postinfusion.2 Long-term monitoring for secondary malignancies, including T-cell malignancies, is also recommended following treatment with liso-cel.
These data from the TRANSCEND FL trial suggest that lisocabtagene maraleucel offers a promising therapeutic strategy for patients with relapsed or refractory MZL, providing high and durable response rates with a manageable safety profile.
Further investigation and long-term follow-up will continue to elucidate the full potential of this therapy in the MZL population.
About MZL
MZL is the second most common indolent non-Hodgkin lymphoma, accounting for approximately 7% of all non-Hodgkin lymphoma cases.1 While initial therapies often achieve prolonged remissions, a significant proportion of patients experience relapse, necessitating further treatment. Current treatment approaches for relapsed/refractory MZL can include anti-CD20–based chemoimmunotherapy, Bruton tyrosine kinase inhibitors, and immunomodulatory agents. However, for patients who relapse early or become refractory to these treatments, there remains an unmet need for effective and tolerable therapies that can induce deep and durable responses.
REFERENCES:
1. Bristol Myers Squibb presents first data from the marginal zone lymphoma cohort of the Transcend FL trial demonstrating deep and durable responses with Breyanzi (lisocabtagene maraleucel). News release. Bristol Myers Squibb. June 16, 2025. Accessed June 16, 2025. https://tinyurl.com/yc7chdcr
2. Breyanzi (lisocabtagene maraleucel) prescribing information. Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. Accessed June 16, 2025. https://tinyurl.com/mtv35ner
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