Durable response to lisocabtagene maraleucel in relapsed, refractory MZL
- 20-02-2026
- Non-Hodgkin Lymphoma
- Editor's Choice
- News
medwireNews: The chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (liso-cel) elicits high rates of durable responses in people with relapsed or refractory marginal zone lymphoma (MZL), indicate phase 2 data.
“The safety profile was manageable, and no new safety signals were identified beyond those observed in lisocabtagene maraleucel studies in other B-cell malignancies,” say M Lia Palomba, from Memorial Sloan Kettering Cancer Center in New York, USA, and team in The Lancet.
They add that the results “show that a one-time infusion of lisocabtagene maraleucel is a highly effective treatment option for patients with relapsed or refractory MZL, providing meaningful clinical benefit to a patient population with a high unmet need.”
The team reports the primary analysis of the MZL cohort of the TRANSCEND FL trial, which recruited 77 patients who had received at least two previous lines of systemic therapy from across 30 sites in the USA, Canada, Europe, and Japan.
All patients underwent leukapheresis and 67 received a single intravenous infusion of liso-cel at a target dose of 100 x 106 CAR+ T cells 2–7 days after lymphodepleting chemotherapy.
The median age of the treated patients was 62 years, they had received a median of three prior treatments, and the majority (79%) had high-risk disease as per the MZL-International Prognostic Index. The most common MZL subtype was nodal, in 48% of patients, followed by splenic and extranodal mucosa-associated lymphoid tissue, in a respective 27% and 25%.
Over a median follow-up of 24.1 months, the primary endpoint of overall response rate by independent review was achieved by 95% of the 66 evaluable participants, meeting the predefined criteria for success.
The complete response rate was 62% and the median duration of response was not reached, and neither were the medians for overall and progression-free survival. At the 24-month mark, 90% of the participants were alive and 86% were alive and free from progression.
Palomba and colleagues highlight that “[a]lthough limited by the small number of patients in certain subgroups, subgroup analyses showed consistent results with the overall population, including in subgroups by MZL subtype or high-risk features.”
Manageable safety profile
In all, 88% of patients experienced treatment-emergent adverse events (TEAEs) of grade 3 or worse, with the most frequent being neutropenia (72%), thrombocytopenia (21%), and leukopenia (19%). There were two TEAEs of grade 5, one case each of neutropenic sepsis and T-cell lymphoma.
Grade 3 cytokine release syndrome (CRS) and neurological events each occurred in 4% of patients and there were no grade 4 or 5 events.
“CRS and neurological events were managed by use of the protocol-specified and standard-of-care guidelines, and all events resolved,” notes the team.
Discussing the results, the investigators say that “[t]he efficacy observed with lisocabtagene maraleucel in patients with relapsed or refractory MZL is encouraging and appears to be substantially improved over that shown by the currently approved therapies in this setting.”
They continue: “However, longer follow-up will be needed to further evaluate response durability and survival outcomes in this population with indolent lymphoma.”
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