Outcomes of lisocabtagene maraleucel (liso-cel) in patients (pt) with relapsed or refractory (R/R) mantle cell lymphoma (MCL): First real-world data from the CIBMTR.

7026 Background: Liso-cel, an autologous, CD19-directed CAR T cell product, demonstrated deep, durable responses with manageable safety in pts with R/R MCL in the MCL cohort of TRANSCEND NHL 001 (NCT02631044). In this study, we present the first report of real-world outcomes for pts with R/R MCL who received liso-cel, using data from CIBMTR. Methods: This retrospective study included pts in the US with R/R MCL who received commercial liso-cel from 05/2024 to 09/2025 with ≥ 1 postinfusion assessment reported to CIBMTR. Effectiveness outcomes included ORR, CR rate, duration of response (DOR), PFS, and OS. Safety outcomes included AEs of special interest, nonrelapse mortality (NRM), and death. Results are descriptive. Results: A total of 94 pts were eligible. Median age was 73 y (range, 46–85), 74% were male, 4% (4/92) had ECOG PS ≥ 2, and 65% (53/81) had ≥ 1 clinically significant comorbidity, with cardiac (31%), pulmonary (31%), and obesity (17%) being most common (> 10%). Largest nodal mass > 10 cm, indicative of bulky disease, was observed in 15% of pts (9/60), 31% had ≥ 2 extranodal involvement, and 5% had CNS involvement. Data on TP53 mutation status and Ki-67 score were limited. Median number of prior lines of therapy (including HSCT/cell therapy) was 4 (range, 2–12); 69% of pts (62/90) had refractory disease and 72% (67/93) received bridging therapy. At a median follow-up of 6.0 mo (95% CI, 5.9–6.2), ORR was 88% (95% CI, 80–94) with CR rate of 80% (95% CI, 70–87). Median DOR, PFS, and OS were not reached; 6-month DOR, PFS, and OS rates were 79% (95% CI, 55–91), 79% (95% CI, 68–87), and 92% (95% CI, 83–96.5), respectively. Any-grade (gr) cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome were reported in 65% (gr ≥ 3, 2%) and 37% (gr ≥ 3, 12%) of pts, respectively, with no gr 5 events. Clinically significant infections were reported in 23% of pts, gr 4 thrombocytopenia and/or neutropenia persistent at 30 days after infusion in 18%, and second primary malignancies in 5%, with skin malignancies being the most common. Gr 3/4 organ toxicity occurred in 1 (1%) pt, and none had tumor lysis syndrome. Nine (10%) pts died, including 6 (6%) due to PD. The NRM rate at 6 mo was 1% (95% CI, 0.1–5.4). Of the 36% of pts planned for outpatient infusion, 59% (20/34) were reported as being hospitalized postinfusion with a median (range) time to hospitalization and stay of 5.5 days (1–35) and 4.5 days (2–32), respectively. Conclusions: These results show that liso-cel is associated with high response rates in a broad population of heavily pretreated pts with R/R MCL with early signs of durable benefit and safety profile consistent with TRANSCEND NHL 001. While longer follow-up is needed, this supports the potential of liso-cel to address critical gaps for pts with limited treatment options, providing strong effectiveness and manageable safety.