TY - JOUR
T1 - Five-Year Analysis of the JULIET Trial of Tisagenlecleucel in Patients With Relapsed/Refractory Large B-Cell Lymphoma
AU - Maziarz, Richard T.
AU - Bishop, Michael R.
AU - Tam, Constantine S.
AU - Borchmann, Peter
AU - Worel, Nina
AU - McGuirk, Joseph P.
AU - Holte, Harald
AU - Waller, Edmund K.
AU - Jaglowski, Samantha
AU - Andreadis, Charalambos
AU - Foley, Stephen Ronan
AU - Westin, Jason R.
AU - Fleury, Isabelle
AU - Ho, P. Joy
AU - Mielke, Stephan
AU - Teshima, Takanori
AU - Janakiram, Murali
AU - Hsu, Jingmei
AU - Izutsu, Koji
AU - Kersten, Marie José
AU - Ghosh, Monalisa
AU - Wagner-Johnston, Nina
AU - Kato, Koji
AU - Corradini, Paolo
AU - Ma, Wanying
AU - Han, Xia
AU - Nuortti, Marja
AU - Awasthi, Rakesh
AU - Mundt, Kirsten E.
AU - Majdan, Marta
AU - Maier, Harald J.
AU - Jegerlehner, Andrea
AU - Salles, Gilles
AU - Schuster, Stephen J.
PY - 2025/11/1
Y1 - 2025/11/1
N2 - 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.
AB - 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.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=105027176227&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/41252666
U2 - 10.1200/JCO-25-00507
DO - 10.1200/JCO-25-00507
M3 - Article
C2 - 41252666
SN - 0732-183X
JO - Journal of clinical oncology
JF - Journal of clinical oncology
ER -
SDG 3 Good Health and Well-being