Real-World Outcomes of Tisagenlecleucel Versus Standard-of-Care Salvage Chemotherapy in Relapsed or Refractory...

Tisagenlecleucel, a CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy, has shown durable efficacy in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). However, comparative real-world data against standard-of-care (SOC) therapies remain scarce in Asian populations.

We performed a retrospective, propensity score-matched cohort study at two tertiary hospitals in Korea. Adult patients with R/R DLBCL treated in the third-line (3L) or later setting received either tisagenlecleucel (CAR-T cohort) or SOC salvage chemoimmunotherapy. Propensity score matching (1:1) was conducted using age, sex, line of therapy, International Prognostic Index, Eastern Cooperative Oncology Group status, and year of diagnosis. Outcomes included response rates, progression-free survival (PFS), overall survival (OS), and safety.

Among 178 eligible patients (CAR-T, n = 67; SOC, n = 111), 100 were matched (50 per group). The CAR-T cohort achieved a significantly higher overall response rate (68% vs. 28%) and complete response rate (60% vs. 22%). Median PFS was 4.8 months for CAR-T vs. 1.6 months for SOC (hazard ratio [HR], 0.49; P = 0.003), and median OS was 11.9 months vs. 3.3 months (HR, 0.51; P = 0.013). Subgroup analyses generally favored CAR-T across most clinical strata. CAR-T toxicities were manageable, with cytokine release syndrome (16%) and neurotoxicity (6%) observed, while SOC regimens were associated with higher chemotherapy-related cytopenias.

In this real-world propensity score-matched comparison from Asia, tisagenlecleucel demonstrated superior survival and response outcomes compared with SOC salvage chemotherapy in Korean patients with R/R DLBCL, supporting its role as the standard of care in the ≥ 3L setting.