학술논문
Axicabtagene ciloleucel as second-line therapy in large B cell lymphoma ineligible for autologous stem cell transplantation: a phase 2 trial.
Document Type
Academic Journal
Author
Houot R; Department of Hematology, University Hospital of Rennes, UMR U1236, INSERM, University of Rennes, French Blood Establishment, Rennes, France. roch.houot@chu-rennes.fr.; Bachy E; Department of Hematology, Lyon Sud Hospital Center, INSERM U1111, Lyon, France.; Cartron G; Department of Hematology, University Hospital of Montpellier, UMR-CNRS 5535, Montpellier, France.; Gros FX; Department of Clinical Hematology and Cellular Therapy, University Hospital of Bordeaux, Bordeaux, France.; Morschhauser F; ULR 7365 - GRITA, University Hospital of Lille, Lille, France.; Oberic L; Department of Hematology, Cancer University Institute of Toulouse Oncopole, Toulouse, France.; Gastinne T; Department of Hematology, University Hospital of Nantes, Nantes, France.; Feugier P; Department of Hematology, University Hospital of Nancy, INSERM 1256, University of Lorraine, Vandœuvre-lès-Nancy, France.; Duléry R; Department of Clinical Hematology and Cellular Therapy, Sorbonne University, Saint-Antoine Hospital, AP-HP, INSERM UMR938, Paris, France.; Thieblemont C; Department of Hematology and Oncology, Saint-Louis Hospital, AP-HP, Paris, France.; Joris M; Department of Hematology, University Hospital of Amiens, Amiens, France.; Jardin F; Department of Clinical Hematology, Henri Becquerel Center, INSERM U1245, Rouen, France.; Choquet S; Department of Hematology, University Hospital Pitié Salpêtrière, AP-HP, Sorbonne University, Paris, France.; Casasnovas O; Department of Clinical Hematology, Dijon University Hospital, INSERM UMR1231, Dijon, France.; Brisou G; Department of Hematology, Institut Paoli-Calmettes, Marseille, France.; Cheminant M; Department of Clinical Hematology, Necker-Enfants Malades University Hospital, AP-HP, INSERM UMR1163, Paris, France.; Bay JO; Department of Clinical Hematology and Cellular Therapy, Clermont-Ferrand University Hospital Center, Clermont-Ferrand, France.; Gutierrez FL; Department of Anatomopathology, University Hospital of Rennes, Rennes, France.; Menard C; French Blood Establishment and SITI Laboratory, UMR U1236, INSERM, University of Rennes, University Hospital Center of Rennes, Rennes, France.; Tarte K; French Blood Establishment and SITI Laboratory, UMR U1236, INSERM, University of Rennes, University Hospital Center of Rennes, Rennes, France.; Delfau MH; Department of Immunology, Henri Mondor Hospital, Créteil, France.; Portugues C; Department of Biostatistics, LYSARC, Lyon-Sud Hospital, Pierre-Bénite, France.; Itti E; Department of Nuclear Medicine, Henri Mondor Hospital, Créteil, France.; Palard-Novello X; Department of Nuclear Medicine, University of Rennes, CLCC Eugène Marquis, INSERM, Rennes, France.; Blanc-Durand P; Department of Nuclear Medicine, CHU H. Mondor, U-PEC, AP-HP, Créteil, France.; Al Tabaa Y; Scintidoc Nuclear Medicine Center, Clinique Clémentville, Montpellier, France.; Bailly C; Nantes-Angers Cancer Research Center CRCI2NA, University of Nantes, INSERM UMR1307, CNRS-ERL6075, Nantes, France.; Laurent C; Department of Pathology, Cancer University Institute of Toulouse Oncopole, CHU Toulouse, CRCT INSERM U1037, Toulouse, France.; Lemonnier F; Lymphoid Malignancies Unit, Henri Mondor Hospital, Mondor Institute for Biomedical Research, INSERM U955, University Paris-Est, Créteil, France.
Source
Publisher: Nature Publishing Company Country of Publication: United States NLM ID: 9502015 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1546-170X (Electronic) Linking ISSN: 10788956 NLM ISO Abbreviation: Nat Med Subsets: MEDLINE
Subject
Language
English
Abstract
Axicabtagene ciloleucel (axi-cel) demonstrated superior efficacy compared to standard of care as second-line therapy in patients with high-risk relapsed/refractory (R/R) large B cell lymphoma (LBCL) considered eligible for autologous stem cell transplantation (ASCT); however, in clinical practice, roughly half of patients with R/R LBCL are deemed unsuitable candidates for ASCT. The efficacy of axi-cel remains to be ascertained in transplant-ineligible patients. ALYCANTE, an open-label, phase 2 study, evaluated axi-cel as a second-line therapy in 62 patients with R/R LBCL who were considered ineligible for ASCT. The primary end point was investigator-assessed complete metabolic response at 3 months from the axi-cel infusion. Key secondary end points included progression-free survival, overall survival and safety. The study met its primary end point with a complete metabolic response of 71.0% (95% confidence interval, 58.1-81.8%) at 3 months. With a median follow-up of 12.0 months (range, 2.1-17.9), median progression-free survival was 11.8 months (95% confidence interval, 8.4-not reached) and overall survival was not reached. There was no unexpected toxicity. Grade 3-4 cytokine release syndrome and neurologic events occurred in 8.1% and 14.5% of patients, respectively. These results support axi-cel as second-line therapy in patients with R/R LBCL ineligible for ASCT. ClinicalTrials.gov Identifier: NCT04531046 .
(© 2023. The Author(s).)
(© 2023. The Author(s).)