Five-Year Analysis of the JULIET Trial of Tisagenlecleucel in Patients With Relapsed/Refractory Large B-Cell Lymphoma
Richard T. Maziarz, Michael Bishop, Constantine S. Tam, Peter Borchmann, Nina Worel, Joseph P. McGuirk, Harald Holte, Edmund K. Waller, Samantha Jaglowski, Charalambos Andreadis, S.R. Foley, Jason R. Westin, Isabelle Fleury, P. Joy Ho, Stephan Mielke, Takanori Teshima, Murali Janakiram, Jingmei Hsu, Koji Izutsu, Marie José Kersten, Monalisa Ghosh, Nina D. Wagner‐Johnston, Koji Kato, Paolo Corradini, Wenlin Ma, Xia Han, Marja Nuortti, Rakesh Awasthi, Kirsten Mundt, Marta Majdan, Harald J. Maier, Andrea Jegerlehner, Gilles Salles, Stephen J. Schuster
Abstract
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.