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Non-Hodgkin Lymphoma
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,1 Kami J. Maddocks,2 Eva González-Barca,3 Wojciech Jurczak,4 Anna Marina Liberati,5 Sven de Vos,6 Zsolt Nagy,7 Aleš Obr,8 Gianluca Gaidano,9 Pau Abrisqueta,10 Nagesh Kalakonda,11 Marc André,12 Martin Dreyling,13 Tobias Menne,14 Olivier Tournilhac,15 Marinela Augustin,16 Andreas Rosenwald,17 Maren Dirnberger-Hertweck,18 Johannes Weirather,18 Sumeet Ambarkhane18 and Gilles Salles19°
1Medizinische Klinik und Poliklinik II, Universitätsklinik Würzburg, Würzburg, Germany; 2Department of Internal Medicine, Arthur G James Comprehensive Cancer Center, Ohio State University Wexner Medical Center, Columbus, OH, USA; 3Department of Hematology, Institut Catalá d’Oncologia (ICO), Hospital Duran i Reynals, Universitat de Barcelona, Barcelona, Spain; 4Maria Sklodowska–Curie National Research Institute of Oncology, Kraków, Poland; 5Università degli Studi di Perugia, Azienda Ospedaliera Santa Maria di Terni, Terni, Italy; 6Department of Medicine, Ronald Reagan UCLA Medical Center, Santa Monica, CA, USA; 71st Department of Internal Medicine, Semmelweis University, Budapest, Hungary; 8Department of Hemato-Oncology, Palacký University and University Hospital, Olomouc, Czech Republic; 9Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy; 10Department of Hematology, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron University Hospital, Barcelona, Spain; 11Molecular and Clinical Cancer Medicine, University of Liverpool and The Clatterbridge Cancer Centre, Liverpool, UK; 12Department of Haematology, Université Catholique de Louvain, CHU UCL Namur, Yvoir, Belgium; 13Department of Medicine III, LMU University Hospital, Munich, Germany; 14Department of Haematology, Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK; 15Service d’Hématologie Clinique et de Thérapie Cellulaire, CHU Estaing, Clermont-Ferrand, France; 16Department of Hematology and Oncology, Paracelcus Medical University, Klinikum Nürnberg, Nürnberg, Germany; 17Institute of Pathology, University of Würzburg, Würzburg, Germany; 18MorphoSys AG, Planegg, Germany and 19Hématologie, Hospices Civils de Lyon and Université de Lyon, Lyon, France.
°Current address: Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
ABSTRACT
Tafasitamab (MOR208), 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) ineligi- ble for autologous stem-cell transplantation. To assess long-term out- comes, we report an updated analysis with ≥35 months’ follow-up. Patients were aged >18 years, had received one to three prior systemic therapies (including ≥1 CD20-targeting regimen) and Eastern Cooperative Oncology Group performance status 0-2. Patients received 28-day cycles of tafasitamab (12 mg/kg intravenously), once weekly dur- ing cycles 1-3, then every 2 weeks during cycles 4-12. Lenalidomide (25 mg orally) was administered on days 1-21 of cycles 1-12. After cycle 12, progression-free patients received tafasitamab every 2 weeks until dis- ease progression. The primary endpoint was best objective response rate. After ≥35 months’ follow-up (data cut-off: October 30, 2020), the objective response rate was 57.5% (n=46/80), including a complete response in 40.0% of patients (n=32/80) and a partial response in 17.5% of patients (n=14/80). The median duration of response was 43.9 months (95% confidence interval [95% CI]: 26.1-not reached), the median over- all survival was 33.5 months (95% CI: 18.3-not reached) and the median progression-free survival was 11.6 months (95% CI: 6.3-45.7). There
Ferrata Storti Foundation
Haematologica 2021 Volume 106(9):2417-2426
Correspondence:
GILLES SALLES
sallesg@mskcc.org
Received: November 13, 2020. Accepted: May 11, 2021. Pre-published: July1,2021.
https://doi.org/10.3324/haematol.2020.275958 ©2021 Ferrata Storti Foundation
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