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Title: Real‐world evidence of tisagenlecleucel for the treatment of relapsed or refractory large B‐cell lymphoma
Author: Iacoboni, Gloria
Villacampa, Guillermo
Martínez Cibrian, Nuria
Bailén, Rebeca
López Corral, Lucia
Sánchez, Jose M.
Guerreiro, Manuel
Caballero, Ana Carolina
Mussetti, Alberto
Sancho, Juan Manuel
Hernani, Rafael
Abrisqueta, Pau
Solano, Carlos
Sureda, Anna
Briones, Javier
Martín García-Sancho, Alejandro
Kwon, Mi
Reguera Ortega, Juan Luis
Barba, Pere
GETH, GELTAMO Spanish Groups
Keywords: Investigació mèdica
Malaltia de Hodgkin
Medicine research
Hodgkin's disease
Issue Date: 1-May-2021
Publisher: Wiley
Abstract: Tisagenlecleucel (tisa-cel) is a second-generation autologous CD19-targeted chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory (R/R) large B-cell lymphoma (LBCL). The approval was based on the results of phase II JULIET trial, with a best overall response rate (ORR) and complete response (CR) rate in infused patients of 52% and 40%, respectively. We report outcomes with tisa-cel in the standard-of-care (SOC) setting for R/R LBCL. Data from all patients with R/R LBCL who underwent leukapheresis from December 2018 until June 2020 with the intent to receive SOC tisa-cel were retrospectively collected at 10 Spanish institutions. Toxicities were graded according to ASTCT criteria and responses were assessed as per Lugano 2014 classification. Of 91 patients who underwent leukapheresis, 75 (82%) received tisa-cel therapy. Grade 3 or higher cytokine release syndrome and neurotoxicity occurred in 5% and 1%, respectively; non-relapse mortality was 4%. Among the infused patients, best ORR and CR were 60% and 32%, respectively, with a median duration of response of 8.9 months. With a median follow-up of 14.1 months from CAR T-cell infusion, median progression-free survival and overall survival were 3 months and 10.7 months, respectively. At 12 months, patients in CR at first disease evaluation had a PFS of 87% and OS of 93%. Patients with an elevated lactate dehydrogenase showed a shorter PFS and OS on multivariate analysis. Treatment with tisa-cel for patients with relapsed/refractory LBCL in a European SOC setting showed a manageable safety profile and durable complete responses.
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It is part of: Cancer Medicine, 2021
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Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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