RT Journal Article
T1 Real-world evidence of tisagenlecleucel for the treatment of relapsed or refractory large B-cell lymphoma.
A1 Iacoboni, Gloria
A1 Villacampa, Guillermo
A1 Martinez-Cibrian, Nuria
A1 Bailén, Rebeca
A1 Lopez Corral, Lucia
A1 Sanchez, Jose M
A1 Guerreiro, Manuel
A1 Caballero, Ana Carolina
A1 Mussetti, Alberto
A1 Sancho, Juan-Manuel
A1 Hernani, Rafael
A1 Abrisqueta, Pau
A1 Solano, Carlos
A1 Sureda, Anna
A1 Briones, Javier
A1 Martin Garcia-Sancho, Alejandro
A1 Kwon, Mi
A1 Reguera-Ortega, Juan Luis
A1 Barba, Pere
A1 GETH, GELTAMO Spanish Groups
K1 clinical cancer research
K1 clinical observations
K1 hematological cancer
K1 non-Hodgkin's lymphoma
AB 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.
YR 2021
FD 2021-05-01
LK http://hdl.handle.net/10668/17730
UL http://hdl.handle.net/10668/17730
LA en
DS RISalud
RD Apr 17, 2025