Multinational phase 2 trial of lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma

The marginal zone lymphoma (MZL) cohort of the phase 2 TRANSCEND FL trial, at 30 centers in the USA, Canada, Europe, and Japan, evaluated the CD19-directed CAR T-cell therapy lisocabtagene maraleucel (liso-cel) for relapsed or refractory (R/R) MZL. The trial included patients who had at least two previous lines of systemic therapy. Patients received liso-cel at a dose of 100 x 10⁶ CAR T cells. Primary end point was overall response rate (ORR) per independent review committee. Of 77 leukapheresed patients, 67 received liso-cel and 66 were efficacy evaluable. MZL subtypes included nodal (48%), splenic (27%), and extranodal-mucoas-associated lymphoid tissue (25%). Median number of previous lines of therapy was 3 (IQR 2-4). Median follow-up was 24.1 months.The ORR was 95% (95% CI 87.3-99.9), meeting the primary endpoint. All patients experienced a treatment-related adverse event. Grade 3 cytokine release syndrome or neurological events occurred in 4% each (no grade 4 or 5 events); 16% had grade ≥ 3 infections. The authors conclude that liso-cel showed high rates of durable responses in R/R MZL patients.