P021 | CAR-T CELL THERAPY OUTCOMES IN RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA: INSIGHTS FROM A SOUTHERN ITALY REGION

Axicabtagene ciloleucel (Axi-cel) and Tisagenlecleucel (Tisa-cel) are 2nd autologous CD19-targeted chimeric antigen receptor (CAR) T-cell therapies approved for patients with relapsed/refractory (R/R) Diffuse Large Cell B Lymphoma (DLBCL). Here, we report retrospective mono-regional real world outcomes of patients treated with Axi-cel and Tisa-cel in the standard of care (SoC) setting for R/R DLBCL, from the Calabrian CAR-T center of CTMO of Reggio Calabria. Since 2020, 52 DLBCL patients have been screened. Clinical characteristics were: median age 66 years (IQR: 52-68,5), median number of prior lines of therapy was 2, with 63,4% refractory to last treatment; 25% failed a prior autologous stem cell transplantation. Bridging therapy was performed in 83,3% of the patients: 48,7% chemoimmunotherapy, 19,5% chemo alone, 2,5% lenalidomide, 7,3% radiotherapy, 7,3% steroids alone. In 12,1% of cases no bridging therapy was performed. Overall response rate (ORR) to bridging was 20%, with 5,7% of complete responses (CRs). All patients received lymphodepletion. Of evaluable patients who underwent CAR-T infusion, 27 (62,8%) received Axi-cel (10 in second-line,17 from third line of treatment), while 14 (32,8%) were treated with Tisa-cel. At day 30, ORR was 45,5% for Axi-cel and 35,7% for Tisa-cel (p=0,6), while at day 90 ORR was 68,4% (63,3% CR) for Axi-cel and 33,3% (22,2% CR) for Tisa-cel (p=0,048). At a median follow-up of 6,9 months (IQR:3,4-12,7), median OS was 8,4 months for Tisa-cel and was not reached for Axi-cel (p=0,09), while median PFS was 3 months for Tisa-cel and 8,8 months for Axi-cel (p=0,04). On univariate analysis, ORR at 30 and 90 days significantly associated with better prognosis, while tumor bulk and >1 of extranodal sites, correlated with worse outcomes. Grade 3 or higher of Cytokine release syndrome (CRS) and neurotoxicity (ICANS) occurred in 3,7% and in 11,1% of Axi-cel treated patients, while no events were observed in the Tisa-cel group. Non relapse mortality (11,3%) was highly influenced by COVID-19 early pandemic (one grade 5 CRS, one cardiac arrest and three COVID-19). In conclusion, outcomes of R/R DLBCL treated with CAR-T cells in our real-life setting are similar to other real-world data and further suggest optimization of early referral process, to better select patients and finally define the real-world cost-effectiveness landscape for this promising therapeutic strategy.