CART‐SIE REAL LIFE STUDY: PRIMARY MEDIASTINAL B‐CELL LYMPHOMA (PMBCL) HAVE A SUPERIOR OUTCOME COMPARED TO LARGE B‐CELL LYMPHOMA (LBCL) TREATED WITH AXICABTAGENE CILOLEUCEL

Introduction: In Italy, axicabtagene ciloleucel (axi-cel) is commercially available for the treatment of LBCL, including diffuse large B-cell lymphoma (DLBCL-NOS), high grade (HGBCL), transformed follicular (tFL), and PMBCL patients, relapsed/refractory (R/R) after at least two prior treatments. Methods: The CART-SIE an ongoing prospective retrospective study collecting data on outcome all consecutive patients treated with CAR-T cells. aim this analysis was to compare LBCL axi-cel in Italian real life. Results: From 2019 2022, 444 were infused. Axi-cel administered 192 patients: 57 135 DLBCL-NOS (85), HGBCL (28) tFL (22), respectively. clinical characteristics versus showed: median age 35 56 (p = 0.0001), bulky 33/57 (58%) 47/135 (35%) 0.0035), limited stage 35/57 (61%) 41/135 (31%) Median follow-up time infused 10.99 months (IQR 4.18, 18.03). Overall Response Rate (ORR, complete CR + partial PR) 30-days infusion 44/57 (77%) 30 (53%) PMBCL, 97/135 (72%) 67 (50%) 0.4206). 12-months Survival (OS) 89% (95% CI: 81–98) 70% 62–80) (log-rank p 0.0016); by different histology subtypes, OS 74% 63–86) DLBCL-NOS, 58% 41–81) HGBCL, 76% 58–100) 0.0013). PFS 65% 53–80) 47% 39–57) 0.0160); 40% 30–54) 51% 35–75) 47–90) 0.0420). All grades CRS observed 49/57 (86%) 118/135 (87%) 9 (16%) 12 (9%) severe (grade 3–4) CRS, respectively; ICANS reported 25 (44%) 46 (34%) (21%) 14 (10%) ICANS, Tocilizumab 41 90 (67%) LBCL; steroids 20 36 (27%) patients. Twelve 15 (11%) admitted intensive care unit. Treatment related mortality 3 (5%) (2%) a multivariable model clinically important unbalanced variables, maintained its significantly superior as compared PFS. Conclusions: first real-life comparing prognosis affected R/R axi-cel. had similar incidence ICANS. Encore Abstract—previously submitted EHA 2023 Keywords: aggressive non-Hodgkin lymphoma, cellular therapies Conflicts interests pertinent abstract A. Chiappella Consultant or advisory role: Celgene-BMS, Gilead-Sciences, Ideogen, Janssen, Roche, SecuraBIO, Takeda Other remuneration: Lecture fees/Educational activities: Astrazeneca, Incyte, Janssen-Cilag, Novartis,