The Outcome of Tisagenlecleucel (Tisa-Cel) Vs Axicabtagene Ciloleucel (Axi-Cel) CD-19 CAR-T Cell Therapy in Relapsed/Refractory NHL: Real World Data from a Single Institution Experience

Background Non-Hodgkin lymphoma (NHL) in Saudi Arabia exhibits an incidence rate of 6.1%, with estimated age adjusted incidence is 6/100,000, presenting at an advanced stage up to 40% stage IV. The CD 19 chimeric antigen receptor (CAR) T-cell therapy targets and eliminates CD19-expressing B cells and shows efficacy against B-cell lymphomas. Methods and patient From November 2020 to May 2023, a 44 patients with relapsed or refractory NHL were included in this retrospective analysis. A 54.5% were male, the median age was 51, and ECOG was 0-3. NHL subtype includes 52% germinal center B-cell (GCB) and 38.6% activated B-cell (ABC), stage III and IV by PET/CT scan was 47.7% for each stage. 9.1% received Axi-Cel CAR-T therapy as second line and 65.9% received ≥ 3 lines of therapy pre CAR-T. 17 patients (16%) relapsed after autologous stem cell transplantation (ASCT) then received CAR-T therapy with Tica-Cel product (n=6). Four patients (9.1%) had controlled CNS disease at the infusion time. All patients received lymphodepletion (LD) therapy with fludarabine and cyclophosphamide (Flu/Cy). 25% (n=11) had bridging chemotherapy therapy before LD, bridging radiation therapy for 13 patients (29.5%). The patients’ characteristics and disease in Table-1. Result Overall response rate (ORR) was 68.2%; complete responses (CR) observed in 43.2% and 25% had partial responses (PR). Disease progression (DP) occurred in 29.5%. In Axi-Cel group, ORR, CR, PR, and DP was 84.2%, 52.6%, 31.6% and 10.5, respectively. In Tica-Cel group; ORR, CR, PR, and DP was 56%, 36%, 20% and 44%, respectively. The estimated 2 years overall survival was 75%; with 89.5% and 64% in Axi-Cel and Tica-Cel, respectively (p=0.47), Figure1. The estimated overall progressive free survival (PFS) was 61.4% with 73.7% in Axi-Cel group and 52% in Tica-Cel group (p=0.2), Figure2, the best PFS was seen in GCB subtype 65.2% vs 47.1% in ABC, (p= 0.05), Figure4. In FL, PFS was 100%, the patient number is small. PFS was 62.5% in-patient with CRS compared with 50% on non-CRS patient, not statistically significant (p= 0.7), Figure3. Cytokines release syndrome (CRS) rate was 90.9% with 9% grade ≥ 3. In Tica-Cel, grade CRS-IV was 9% while 0% in Axi-Cel. Neurotoxicity (NT)-ICANS was 27% with grade ≥ 3 of 13.6% in both groups. Tocilizumab was used in 72.7% with higher number of patients in Axi-Cel (98.5%). CRS treated with Dexamethasone (Dexa) in 36.4%, with 42% and 32% in Axi-Cel and Tica-Cel, respectively. In ICANS; Dexa required in 31.6% of Axi-Cel and 20% in Tica-Cel group. The mortality was 10.5% in Axi-Cel and 36% in Tica-Cel. Table-2. Conclusions CAR-T cell therapy demonstrated promising results for relapsed or refractory NHL. Axi-Cel showed a higher ORR. Toxicity profiles were similar between the two products, with slightly higher grade III-IV ICANS in the Tica-Cel group. Longer follow-up is crucial for better understand the comparative effectiveness of CAR-T therapies.