Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma
Sattva S. Neelapu,Frederick L. Locke,Nancy L. Bartlett,Lazaros J. Lekakis,David B. Miklos,Caron A. Jacobson,Ira Braunschweig,Olalekan O. Oluwole,Tanya Siddiqi,Yi Lin,John M. Timmerman,Patrick J. Stiff,Jonathan W. Friedberg,Ian W. Flinn,Andre Goy,Brian T. Hill,Mitchell R. Smith,Abhinav Deol,Umar Farooq,Peter A. McSweeney,Javier Munoz,Irit Avivi,Januario E. Castro,Jason R. Westin,Julio C. Chavez,Armin Ghobadi,Krishna V. Komanduri,Ronald Levy,Eric D. Jacobsen,Thomas E. Witzig,Patrick M. Reagan,Adrian Bot,John J. Rossi,Lynn Navale,Yizhou Jiang,Jeff Aycock,Meg Elias,David Z. Chang,Jeff Wiezorek,William Y. Go +39 more
TLDR
Patients with refractory large B‐cell lymphoma who received CAR T‐cell therapy with axi‐cel had high levels of durable response, with a safety profile that included myelosuppression, the cytokine release syndrome, and neurologic events.Abstract:
BackgroundIn a phase 1 trial, axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, showed efficacy in patients with refractory large B-cell lymphoma after the failure of conventional therapy. MethodsIn this multicenter, phase 2 trial, we enrolled 111 patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, or transformed follicular lymphoma who had refractory disease despite undergoing recommended prior therapy. Patients received a target dose of 2×106 anti-CD19 CAR T cells per kilogram of body weight after receiving a conditioning regimen of low-dose cyclophosphamide and fludarabine. The primary end point was the rate of objective response (calculated as the combined rates of complete response and partial response). Secondary end points included overall survival, safety, and biomarker assessments. ResultsAmong the 111 patients who were enrolled, axi-cel was successfully manufactured for 110 (99%) and administered to 101 (91%)....read more
Citations
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Chimeric Antigen Receptor T-Cell Therapy
Ndiya Ogba,Nicole M. Arwood,Nancy L. Bartlett,Mara Bloom,Patrick A. Brown,Christine E. Brown,Elizabeth Lihua Budde,Robert W. Carlson,Stephanie Farnia,Terry J. Fry,Morgan Garber,Rebecca A. Gardner,Lauren Gurschick,Patricia Kropf,Jeff J. Reitan,Craig S. Sauter,Bijal D. Shah,Elizabeth J. Shpall,Steven T. Rosen +18 more
TL;DR: The current state of CAR T-cell therapy and future strategies that should be considered as the application of this novel immunotherapy expands and evolves are described.
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Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma.
Johannes Duell,Kami J. Maddocks,Eva González-Barca,Wojciech Jurczak,Anna Marina Liberati,Sven de Vos,Zsolt Nagy,Aleš Obr,Gianluca Gaidano,Pau Abrisqueta,Nagesh Kalakonda,Marc André,Martin Dreyling,Tobias Menne,Olivier Tournilhac,Marinela Augustin,Andreas Rosenwald,Maren Dirnberger-Hertweck,Johannes Weirather,Sumeet Ambarkhane,Gilles Salles +20 more
TL;DR: Tafasitamab (MOR208) as discussed by the authors is an Fc-modified, humanized, anti-CD19 monoclonal antibody combined with the immunomodulatory drug lenalidomide was clinically active with a good tolerability profile in the open-label, single-arm, phase II L-MIND study of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) ineligible for autologous stem-cell transplantation.
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Clinical applications of donor lymphocyte infusion from an HLA-haploidentical donor: consensus recommendations from the Acute Leukemia Working Party of the EBMT.
Bhagirathbhai Dholaria,Bipin N. Savani,Myriam Labopin,Leo Luznik,A. Ruggeri,Stephan Mielke,Monzr M. Al Malki,Piyanuch Kongtim,Ephraim J. Fuchs,Xiao-Jun Huang,Franco Locatelli,Franco Aversa,Luca Castagna,Andrea Bacigalupo,Massimo F. Martelli,Didier Blaise,Patrick Ben Soussan,Yolande Arnault,Rupert Handgretinger,Denis-Claude Roy,Paul O'Donnell,Asad Bashey,Scott D. Solomon,Rizwan Romee,Philippe Lewalle,Jorge Gayoso,Michael Maschan,Hillard M. Lazarus,Karen K. Ballen,Sebastian Giebel,Frédéric Baron,Fabio Ciceri,Jordi Esteve,Norbert Claude Gorin,Alexandros Spyridonidis,Christoph Schmid,Stefan O. Ciurea,Arnon Nagler,Mohamad Mohty +38 more
TL;DR: The available evidence on the use of donor lymphocyte infusion from haploidentical donor is summarized, and recommendations on its therapeutic, pre-emptive and prophylactic use in clinical practice are provided.
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TL;DR: Diagnostic criteria for a severe cytokine release syndrome (sCRS) is defined and serum C-reactive protein, a readily available laboratory study, can serve as a reliable indicator for the severity of the CRS.
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