| Autor: |
Duell J; Medizinische Klinik und Poliklinik II, Universitätsklinik Würzburg, Würzburg, Germany., Maddocks KJ; Department of Internal Medicine, Arthur G James Comprehensive Cancer Center, Ohio State University Wexner Medical Center, Columbus, OH, USA., González-Barca E; Department of Hematology, Institut Catalá d'Oncologia (ICO), Hospital Duran i Reynals, Universitat de Barcelona, Barcelona, Spain., Jurczak W; Maria Sklodowska-Curie National Research Institute of Oncology, Kraków, Poland., Liberati AM; Università degli Studi di Perugia, Azienda Ospedaliera Santa Maria di Terni, Terni, Italy., De Vos S; Department of Medicine, Ronald Reagan UCLA Medical Center, Santa Monica, CA, USA., Nagy Z; 1st Department of Internal Medicine, Semmelweis University, Budapest, Hungary., Obr A; Department of Hemato-Oncology, Palacký University and University Hospital, Olomouc, Czech Republic., Gaidano G; Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy., Abrisqueta P; Department of Hematology, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital, Barcelona, Spain., Kalakonda N; Molecular and Clinical Cancer Medicine, University of Liverpool and The Clatterbridge Cancer Centre, Liverpool, United Kingdom., André M; Department of Haematology, Université Catholique de Louvain, CHU UCL Namur, Yvoir, Belgium., Dreyling M; Department of Medicine III, LMU University Hospital, Munich, Germany., Menne T; Department of Haematology, Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, United Kingdom., Tournilhac O; Service d'Hématologie Clinique et de Thérapie Cellulaire, CHU Estaing, Clermont-Ferrand, France., Augustin M; Department of Hematology and Oncology, Paracelcus Medical University, Klinikum Nürnberg, Nürnberg, Germany., Rosenwald A; Institute of Pathology, University of Würzburg, Würzburg, Germany., Dirnberger-Hertweck M; MorphoSys AG, Planegg, Germany., Weirather J; MorphoSys AG, Planegg, Germany., Ambarkhane S; MorphoSys AG, Planegg, Germany., Salles G; Hématologie, Hospices Civils de Lyon and Université de Lyon, Lyon, France. sallesg@mskcc.org. |
| Abstrakt: |
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) ineligible for autologous stem-cell transplantation. To assess long-term outcomes, 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 during 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 disease 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 overall 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 were no unexpected toxicities. Subgroup analyses revealed consistent long-term efficacy results across most subgroups of patients. This extended follow-up of L-MIND confirms the long duration of response, meaningful overall survival, and well-defined safety profile of tafasitamab plus lenalidomide followed by tafasitamab monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma ineligible for autologous stem cell transplantation. ClinicalTrials.gov identifier: NCT02399085. |
