Multinational phase 2 trial of tisagenlecleucel for relapsed/refractory large B-cell lymphoma: five-year follow-up of JULIET

The multinational phase 2 JULIET trial evaluated tisagenlecleucel for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL), excluding primary mediastinal LBCL, who had progressed after two or more previous lines of therapy. Five-year results of the trial have now been published. The median follow-up was 74.3 months. The median duration of response was not reached; the 60-month, relapse-free probability was 61% among responders. Higher relapse-free probability (DOR > 70%) was observed in females and those with less than two baseline IPI risk factors or with baseline stage I/II disease. Progression-free survival rate at 60 months was 28% and the overall survival rate at 60 months was 32% for all infused patients and 56% for those achieving complete or partial response. Baseline characteristics associated with achieving a response at any time after infusion included relapsed versus refractory disease, one versus two or more bridging regimens, LDH level ≤ upper limit of normal versus > ULN, and CRP levels ≤ 15 mg/L versus > 15 mg/L. No new safety signals or secondary T-cell malignancies were reported. The authors conclude that these results support the curative potential of tisagenlecleucel in a subset of patients with R/R LBCL.