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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 Duell, Johannes Maddocks, Kami J. González Barca, Eva Jurczak, Wojciech Liberati, Anna Marina Vos, Sven de Nagy, Zsolt Obr, Aleš Gaidano, Gianluca Abrisqueta Costa, Pau Kalakonda, Nagesh André, Marc Dreyling, Martin Menne, Tobias Tournilhac, Olivier Augustin, Marinela Rosenwald, Andreas Dirnberger-Hertweck, Maren Weirather, Johannes Ambarkhane, Sumeet Salles, Gilles Trasplantament d'òrgans Malalties del sistema limfàtic Cèl·lules B Transplantation of organs Lymphatic diseases B cells 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. 2021-09-17T08:38:23Z 2021-09-17T08:38:23Z 2021-07-01 2021-09-16T08:08:41Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Reproducció del document publicat a: https://doi.org/10.3324/haematol.2020.275958 Haematologica, 2021, vol. 106, num. 9, p. 2417-2426 https://doi.org/10.3324/haematol.2020.275958 cc by-nc (c) Duell, Johannes et al, 2021 http://creativecommons.org/licenses/by-nc/3.0/es/ info:eu-repo/semantics/openAccess Ferrata Storti Foundation Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))