Best Treatment Option for Patients With Refractory Aggressive B-Cell Lymphoma in the CAR-T Cell Era: Real-World Evidence From GELTAMO/GETH Spanish Groups.

Abstract

Real-world evidence comparing the efficacy of chimeric antigen receptor (CAR) T-cell therapy against that of the previous standard of care (SOC) for refractory large B-cell lymphoma (LBCL) is scarce. We retrospectively collected data from patients with LBCL according to SCHOLAR-1 criteria treated with commercial CAR T-cell therapy in Spain (204 patients included and 192 treated, 101 with axicabtagene ciloleucel [axi-cel], and 91 with tisagenlecleucel [tisa-cel]) and compared the results with a historical refractory population of patients (n = 81) obtained from the GELTAMO-IPI study. We observed superior efficacy for CAR-T therapy (for both axi-cel and tisa-cel) over pSOC, with longer progression-free survival (PFS) (median of 5.6 vs. 4-6 months, p ≤ 0.001) and overall survival (OS) (median of 15 vs. 8 months, p < 0.001), independently of other prognostic factors (HR: 0.59 (95% CI: 0.44-0.80); p < 0.001] for PFS, and 0.45 [(95% CI: 0.31-0.64)] for OS). Within the CAR-T cohort, axi-cel showed longer PFS (median of 7.3 versus 2.8 months, respectively, p = 0.027) and OS (58% versus 42% at 12 months, respectively, p = 0.048) than tisa-cel. These differences were maintained in the multivariable analysis. On the other hand, axi-cel was independently associated with a higher risk of severe cytokine release syndrome and neurotoxicity. Our results suggest that the efficacy of CAR-T cell therapy is superior to pSOC in the real-world setting. Furthermore, axi-cel could be superior in efficacy to tisa-cel, although more toxic, in this group of refractory patients according to SCHOLAR-1 criteria.

• Authors: Mariana Bastos-Oreiro, Antonio Gutierrez, Juan Luís Reguera, Gloria Iacoboni, Lucía López-Corral, María José Terol, Valentín Ortíz-Maldonado, Jaime Sanz, Luisa Guerra-Dominguez, Rebeca Bailen, Alberto Mussetti, Pau Abrisqueta, Rafael Hernani, Hugo Luzardo, Juan-Manuel Sancho, Javier Delgado-Serrano, Antonio Salar, Carlos Grande, Leyre Bento, Sonia González de Villambrosía, Daniel García-Belmonte, Anna Sureda, Antonio Pérez-Martínez, Pere Barba, Mi Kwon, Alejandro Martín García-Sancho
• Journal: Frontiers in immunology (Front Immunol) Vol. 13 Pg. 855730 ( 2022) ISSN: 1664-3224 [Electronic] Switzerland
• PMID: 35911769 (Publication Type: Journal Article)
• Copyright: Copyright © 2022 Bastos-Oreiro, Gutierrez, Reguera, Iacoboni, López-Corral, Terol, Ortíz-Maldonado, Sanz, Guerra-Dominguez, Bailen, Mussetti, Abrisqueta, Hernani, Luzardo, Sancho, Delgado-Serrano, Salar, Grande, Bento, González de Villambrosía, García-Belmonte, Sureda, Pérez-Martínez, Barba, Kwon and Martín García-Sancho.

Chemical References

• Antigens, CD19
• Receptors, Chimeric Antigen

Topics

• Antigens, CD19
• Humans
• Lymphoma, Large B-Cell, Diffuse (pathology)
• Receptors, Chimeric Antigen (genetics)
• Retrospective Studies
• T-Lymphocytes