The academic point‐of‐care anti‐CD19 chimeric antigen receptor T‐cell product varnimcabtagene autoleucel (ARI‐0001 cells) shows efficacy and safety in the treatment of relapsed/refractory B‐cell non‐Hodgkin lymphoma

Author:

Martínez‐Cibrián Núria1,Ortiz‐Maldonado Valentín12ORCID,Español‐Rego Marta23,Blázquez Andrea1,Cid Joan245ORCID,Lozano Miquel245,Magnano Laura12ORCID,Giné Eva126,Correa Juan G.1,Mozas Pablo12ORCID,Rodríguez‐Lobato Luis Gerardo12,Rivero Andrea12,Montoro‐Lorite Mercedes1,Ayora Pilar1,Navarro Sergio23,Alserawan Leticia3,González‐Navarro E. Azucena3,Castellà Maria23,Sánchez‐Castañón María3,Cabezón Raquel3,Benítez‐Ribas Daniel23,Setoaín Xavier578,Rodríguez Sonia9,Brillembourg Helena1,Varea Sara210,Olesti Eulalia2510,Guillén Elena210,Sáez‐Peñataro Joaquín210,de Larrea Carlos Fernández125,López‐Guillermo Armando1256ORCID,Pascal Mariona23,Urbano‐Ispizua Álvaro125,Juan Manel235,Delgado Julio1256ORCID

Affiliation:

1. Department of Hematology Hospital Clínic Barcelona Spain

2. Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) Barcelona Spain

3. Department of Immunology Hospital Clínic Barcelona Spain

4. Apheresis Unit Hospital Clínic Barcelona Spain

5. University of Barcelona Barcelona Spain

6. CIBERONC Madrid Spain

7. Department of Nuclear Medicine Hospital Clínic Barcelona Spain

8. CIBERBBN Madrid Spain

9. Department of Radiology Hospital Clínic Barcelona Spain

10. Department of Clinical Pharmacology Hospital Clínic Barcelona Spain

Abstract

SummaryVarnimcabtagene autoleucel (var‐cel) is an academic anti‐CD19 chimeric antigen receptor (CAR) product used for the treatment of non‐Hodgkin lymphoma (NHL) in the CART19‐BE‐01 trial. Here we report updated outcomes of patients with NHL treated with var‐cel. B‐cell recovery was compared with patients with acute lymphoblastic leukaemia (ALL). Forty‐five patients with NHL were treated. Cytokine release syndrome (any grade) occurred in 84% of patients (4% grade ≥3) and neurotoxicity in 7% (2% grade ≥3). The objective response rate was 73% at Day +100, and the 3‐year duration of response was 56%. The 3‐year progression‐free and overall survival were 40% and 52% respectively. High lactate dehydrogenase was the only covariate with an impact on progression‐free survival. The 3‐year incidence of B‐cell recovery was lower in patients with NHL compared to ALL (25% vs. 60%). In conclusion, in patients with NHL, the toxicity of var‐cel was manageable, while B‐cell recovery was significantly prolonged compared to ALL. This trial was registered as NCT03144583.

Funder

Instituto de Salud Carlos III

Generalitat de Catalunya

Publisher

Wiley

Subject

Hematology

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