Axicabtagene ciloleucel compared to tisagenlecleucel for the treatment of aggressive B-cell lymphoma
Por:
Kwon M., Iacoboni G., Reguera J.L., López Corral L., Morales R.H., Ortiz-Maldonado V., Guerreiro M., Caballero A.C., Domínguez M.L.G., Pina J.M.S., Mussetti A., Sancho J.M., Bastos-Oreiro M., Catala E., Delgado J., Henriquez H.L., Sanz J., Calbacho M., Bailén R., Carpio C., Ribera J.M., Sureda A., Briones J., Hernandez-Boluda J.C., Cebrián N.M., Martin J.L.D., Martín A., Barba P.
Publicada:
1 ene 2023
Ahead of Print:
1 ene 2023
Resumen:
Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are CD19-targeted chimeric antigen receptor (CAR) T cells approved for relapsed/refractory (R/R) large B-cell lymphoma (LBCL). We performed a retrospective study to evaluate safety and efficacy of axi-cel and tisa-cel outside the setting of a clinical trial. Data from consecutive patients with R/R LBCL who underwent apheresis for axi-cel or tisa-cel were retrospectively collected from 12 Spanish centers. A total of 307 patients underwent apheresis for axi-cel (n=152) and tisa-cel (n=155) from November 2018 to August 2021, of which 261 (85%) received a CAR T infusion (88% and 82%, respectively). Median time from apheresis to infusion was 41 days for axi-cel and 52 days for tisa-cel (P=0.006). None of the baseline characteristics were significantly different between both cohorts. Both cytokine release syndrome and neurologic events (NE) were more frequent in the axi-cel group (88% vs. 73%, P=0.003, and 42% vs. 16%, P<0.001, respectively). Infections in the first 6 months post-infusion were also more common in patients treated with axi-cel (38% vs. 25%, P=0.033). Non-relapse mortality was not significantly different between the axi-cel and tisa-cel groups (7% and 4%, respectively, P=0.298). With a median follow-up of 9.2 months, median PFS and OS were 5.9 and 3 months, and 13.9 and 11.2 months for axi-cel and tisa-cel, respectively. The 12-month PFS and OS for axi-cel and tisa-cel were 41% and 33% (P=0.195), 51% and 47% (P=0.191), respectively. Factors associated with lower OS in the multivariate analysis were increased lactate dehydrogenase, ECOG =2 and progressive disease before lymphodepletion. Safety and efficacy results in our real-world experience were comparable with those reported in the pivotal trials. Patients treated with axi-cel experienced more toxicity but similar non-relapse mortality compared with those receiving tisa-cel. Efficacy was not significantly different between both products. ©2023 Ferrata Storti Foundation.
Filiaciones:
Kwon M.:
Department of Hematology, Hospital General Universitario Gregorio Marañón, Madrid, Spain
Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain
Iacoboni G.:
Department of Hematology, Vall d’Hebron University Hospital, Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
Department of Medicine, Universitat Autonoma de Barcelona, Bellaterra, Spain
Reguera J.L.:
Department of Hematology, Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla, Sevilla, Spain
López Corral L.:
Department of Hematology, Hospital Clínico Universitario de Salamanca, IBSAL, Salamanca, Spain
Morales R.H.:
Department of Hematology, Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain
Ortiz-Maldonado V.:
Department of Hematology, Hospital Clínic, Barcelona, Spain
Guerreiro M.:
Department of Hematology, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Caballero A.C.:
Department of Hematology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Domínguez M.L.G.:
Department of Hematology, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, Spain
Pina J.M.S.:
Department of Hematology, Hospital Universitario 12 de Octubre, Madrid, Spain
Mussetti A.:
Department of Hematology, Hospital Duran i Reynals, Instituto Catalán de Oncología, Barcelona, Spain
Sancho J.M.:
Department of Hematology, Hospital Universitari Germans Trias i Pujol, Instituto Catalán de Oncología, Josep Carreras Research Institute, Badalona, Spain
Bastos-Oreiro M.:
Department of Hematology, Hospital General Universitario Gregorio Marañón, Madrid, Spain
Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain
Catala E.:
Department of Hematology, Vall d’Hebron University Hospital, Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
Department of Medicine, Universitat Autonoma de Barcelona, Bellaterra, Spain
Delgado J.:
Department of Hematology, Hospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla, Sevilla, Spain
Henriquez H.L.:
Department of Hematology, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, Spain
Sanz J.:
Department of Hematology, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Calbacho M.:
Department of Hematology, Hospital Universitario 12 de Octubre, Madrid, Spain
Bailén R.:
Department of Hematology, Hospital General Universitario Gregorio Marañón, Madrid, Spain
Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain
Carpio C.:
Department of Hematology, Vall d’Hebron University Hospital, Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
Department of Medicine, Universitat Autonoma de Barcelona, Bellaterra, Spain
Ribera J.M.:
Department of Hematology, Hospital Universitari Germans Trias i Pujol, Instituto Catalán de Oncología, Josep Carreras Research Institute, Badalona, Spain
Sureda A.:
Department of Hematology, Hospital Duran i Reynals, Instituto Catalán de Oncología, Barcelona, Spain
Briones J.:
Department of Hematology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Hernandez-Boluda J.C.:
Department of Hematology, Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain
Cebrián N.M.:
Department of Hematology, Hospital Clínic, Barcelona, Spain
Martin J.L.D.:
Department of Hematology, Hospital General Universitario Gregorio Marañón, Madrid, Spain
Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain
Universidad Complutense de Madrid, Madrid, Spain
Martín A.:
Department of Hematology, Hospital Clínico Universitario de Salamanca, IBSAL, Salamanca, Spain
Barba P.:
Department of Hematology, Vall d’Hebron University Hospital, Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
Department of Medicine, Universitat Autonoma de Barcelona, Bellaterra, Spain
Green Published, gold, All Open Access, Bronze, Green
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