Five-Year Analysis of the JULIET Trial of Tisagenlecleucel in Patients With Relapsed/Refractory Large B-Cell Lymphoma.

We report the 5-year analysis of tisagenlecleucel in 115 infused patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL) from the single-arm, open-label, multicenter, global, phase II JULIET trial (ClinicalTrials.gov identifier: NCT02445248), with a median follow-up of 74.3 months. The median duration of response (DOR) 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 International Prognostic Index risk factors or with baseline stage I/II disease. The estimated probability of progression-free survival at 60 months was 28%. The probability of overall survival (OS) 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, lactate dehydrogenase level ≤upper limit of normal (ULN) versus >ULN, and C-reactive protein levels <15 mg/L versus >15 mg/L. Baseline characteristics associated with long-term OS included lactate dehydrogenase ≤ULN and C-reactive protein <15 mg/L. No new safety signals or secondary T-cell malignancies were reported. These findings continue to support the curative potential of tisagenlecleucel in a subset of patients with r/r LBCL.