A real-world experience of axicabtagene ciloleucel CAR-T in refractory/relapsed B-cell lymphoma from a tertiary center in Saudi Arabia

Abstract Introduction: Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 CAR T-cell therapy approved for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) who have received a prior two or more lines of therapy. Our center, King Fahad Medical City in Saudi Arabia, has been administering (axi-cel) since November 2023. This is one of few reported outcomes from middle east. Objective: To evaluate our outcome and the management of complications of CAR-T therapy in a real-world setting. Method: We retrospectively analyzed data from 17 patients aged 31 to 76 years treated with Axicabtagene ciloleucel (axi-cel) between November 2023 and February 2025. Baseline characteristics, response rates, relapse-free survival (RFS), overall survival (OS), and toxicity data including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were collected. Results: A total of 17 patients received Axi-cel for refractory/relapsed large B-cell lymphomas. The median age was 60 years (range 31-76) and 52% (n=9) were males. The median length of inpatient stay was 29 days (range 20-57). Sixteen patients had a diffuse large B-cell lymphoma (DLBCL), while once patient had a primary mediastinal B-cell lymphoma (PMBCL). Majority of patient 88% had a histologic subtype of germinal center B-cell (GCB) subtype of DLBCL, while 1 patient was non-GCB and another patient had a T-cell rich B-cell lymphoma. Prior CAR-T infusion, 76% (n=13) had an advanced stage (IV). Most patient (70%) required 2 line of therapy prior to CAR-T with 24% of the patient has an early disease relapse (<12 month) and 29% had a late relapse after the first line of therapy while the disease was refractory in 47% of the patients. Only 12% of the patient achieved complete response (CR) prior to CAR-T infusion. At day 30 post CAR-T infusion, overall response rate for the total 17 patients based on PET/CT was as follows: Complete response (CR): 76% (n=13), stable disease: 5% (n=1), Disease progression (DP): 18% (n=3). At the time of analysis, 76% (n=13) were alive while 4 patients died, 2 of them due to septic shock and the other 2 patients had a chest infection. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 7 pts (41%). Four patients (24%) had ICANS grade I-II while 3 patients (18%) had ICANS grade III-IV. 76% of the patient required steroids therapy and all of the patients revived Tocilizumab. ICU admission was required in 8 patients (47%). At 12 months, Overall survival (OS) for all pts was 94% and it was 65% at 24 months. Progression-free survival (PFS) was 70% at 12 months. One patient with PMBCL achieved CR but had disease progression after 2 months of CAR-T infusion. Another patient with DLBCL had disease progression in 8 months. Conclusion: This real-word data highlights the effectiveness of Axicabtagene ciloleucel (axi-cel) in treating relapsed/refractory large B-cell lymphomas with manageable CRS and ICANs with similar outcome from the same region.