Five-Year Analysis of the JULIET Trial of Tisagenlecleucel in Patients With Relapsed/Refractory Large B-Cell Lymphoma
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.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (34)
Richard T. Maziarz
2Knight Cancer Institute, Oregon Health & Science University, Portland, OR
Michael R. Bishop
Constantine S. Tam
40Department of Haematology, Alfred Hospital and Monash University, Melbourne, VIC, Australia
Peter Borchmann
Uniklinik Koeln, Koeln, Germany
Nina Worel
8Medical University of Vienna, Department of Transfusion Medicine and Cell Therapy, Vienna, Austria
Joseph P. McGuirk
Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, Westwood, KS
Harald Holte
8Department of Oncology, Oslo University Hospital and KG Jebsen Center for B-cell Malignancies, Oslo, Norway
Edmund K. Waller
Samantha Jaglowski
17Center for International Blood & Marrow Transplant Research® Medical College of Wisconsin, Milwaukee, United States
Charalambos Andreadis
1University of California, San Francisco, United States
Stephen Ronan Foley
Juravinski Hospital and Cancer Centre, McMaster University, Hamilton, ON, Canada
Jason R. Westin
Isabelle Fleury
2Maisonneuve-Rosemont Hospital, Institut Universitaire d'Hémato-Oncologie et de Thérapie Cellulaire, Montreal, Canada
P. Joy Ho
4Department of Haematology, Royal Prince Alfred Hospital, Camperdown, Australia
Stephan Mielke
16Karolinska University Hospital, Stockholm, Sweden
Takanori Teshima
Murali Janakiram
10City of Hope, Duarte, United States
Jingmei Hsu
NYU Perlmutter Cancer Center, NYU Grossman School of Medicine, New York, NY
Koji Izutsu
National Cancer Center Hospital, Tokyo, Japan
Marie José Kersten
Monalisa Ghosh
Nina Wagner-Johnston
9The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
Koji Kato
Paolo Corradini
8Istituto Nazionale Tumori IRCCS, Haematology, Milan, Italy
Wanying Ma
Daiichi Sankyo, Inc., Basking Ridge, NJ
Xia Han
Marja Nuortti
Novartis Pharma AG, Basel, Switzerland
Rakesh Awasthi
32Novartis Pharmaceuticals Corporation, East Hanover, United States
Kirsten E. Mundt
Novartis Pharma AG, Basel, Switzerland
Marta Majdan
Novartis Pharmaceuticals Corporation, East Hanover, NJ
Harald J. Maier
Novartis Pharma AG, Basel, Switzerland
Andrea Jegerlehner
Novartis Pharma AG, Basel, Switzerland
Gilles Salles
41Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York, NY
Stephen J. Schuster
Lymphoma Program, Abramson Cancer Center, Division of Hematology Oncology, Department of Medicine, University of Pennsylvania