Real-world clinical outcomes of tisagenlecleucel in relapsed or refractory diffuse large B-cell lymphoma: a single-center retrospective study

Introduction: Tisagenlecleucel (Tisa-cel), approved by the Korean Ministry of Food and Drug Safety (MFDS) in 2021 and reimbursed since April 2022, is currently the only second-generation chimeric antigen receptor (CAR) T-cell therapy available in Korea. This study aimed to evaluate the real-world efficacy, safety, logistics, and outcomes of Tisa-cel in Korean patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and identify prognostic factors associated with survival. Methods: We retrospectively analyzed 79 patients with R/R DLBCL who received Tisa-cel at the Catholic Hematology Hospital between April 2022 and January 2025. Results: The median decision-to-infusion and vein-to-vein times were 49 and 40 days, respectively. Bridging chemotherapy was administered to 64 patients, with an overall response rate (ORR) of 40.6% and a complete response (CR) rate of 14.1% before infusion. Three months after Tisa-cel treatment, the ORR and CR rates were 72.9% and 64.4%, respectively. Tisa-cel was administered as third-line therapy in 50.6% of the patients, and 48.1% had refractory disease. Of the patients who experienced relapse (43%), approximately half transitioned to palliative care, 8.8% were enrolled in clinical trials, and 5.9% proceeded to allogeneic transplantation. Non-relapse mortality was 11.7%, primarily due to infections (n = 7) and immune effector cell-associated neurotoxicity syndrome (ICANS)-related events (n = 2). Cytokine release syndrome occurred in 70.9% of patients (grade ≥ 3 in 22.8%) and ICANS in 21.5% (grade ≥ 3 in 8.8%), with a median onset at 2 and 5 days, respectively. Tocilizumab and dexamethasone were used in 45.6% and 13.9% of the patients, respectively. With a median follow-up of 11.6 months, the median progression-free survival was 4.9 months, and the median overall survival was 21.6 months. Achieving CR at 3 months was strongly associated with superior survival (p < 0.001). Discussion: Tisa-cel demonstrated favorable efficacy and manageable safety in Korean patients with R/R DLBCL. Early CR strongly predicted long-term outcomes, whereas ICANS occurrence and steroid use were associated with poorer prognosis, underscoring the need to optimize toxicity management.