韓国における再発または難治性びまん性大細胞型B細胞リンパ腫治療のためのチサゲンレクルユーセルに関する実体験

Chimeric antigen receptor T-cell therapy represents a revolutionary advancement in personalized treatment for diffuse large B-cell lymphoma (DLBCL). However, data regarding the use of tisagenlecleucel (tisa-cel) outside of clinical trials remain scarce, especially in East Asia. Therefore, we conducted this study to provide insights into the logistics, efficacy, and safety profile of tisa-cel treatment in Korea.

Clinical data were collected from 46 patients with DLBCL who underwent leukapheresis for commercial tisa-cel manufacturing at Seoul National University Hospital between January 2022 and December 2023. Response evaluations were conducted at 1, 3, 6, and 12 months after tisa-cel infusion.

Overall, 44 patients received tisa-cel infusion. The median time from tisa-cel order placement to product delivery and subsequent infusion was 28 days (range, 24-84) and 42 days (range, 29-118), respectively. The overall response rate was 70.5%, with a complete response rate of 47.7%. Patients who achieved an overall response at 3 months post-infusion had longer overall survival (median, not reached vs 2.6 months, p < 0.001) and progression-free survival (median, 13.0 months vs 1.4 months, p < 0.001) compared to those who did not. Additionally, an elevated baseline LDH was associated with poor survival. Cytokine release syndrome was observed in 70.5% of the patients (grade ⩾3, 4.5%), while immune effector cell-associated neurotoxicity syndrome occurred in 15.9%.

To the best of our knowledge, this study presents the first real-world data on tisa-cel outcomes in Korean patients with DLBCL. Commercial tisa-cel is a feasible treatment option for patients with DLBCL in real-world settings.