2026-04-17T07:45:13Zhttps://recercat.cat/oai/request
oai:recercat.cat:2445/1800672025-12-05T12:42:48Zcom_2072_1057col_2072_478916col_2072_478917
RECERCAT author Duell, Johannes author Maddocks, Kami J. author González Barca, Eva author Jurczak, Wojciech author Liberati, Anna Marina author Vos, Sven de author Nagy, Zsolt author Obr, Aleš author Gaidano, Gianluca author Abrisqueta Costa, Pau author Kalakonda, Nagesh author André, Marc author Dreyling, Martin author Menne, Tobias author Tournilhac, Olivier author Augustin, Marinela author Rosenwald, Andreas author Dirnberger-Hertweck, Maren author Weirather, Johannes author Ambarkhane, Sumeet author Salles, Gilles 2021-09-17T08:38:23Z2021-09-17T08:38:23Z2021-07-012021-09-16T08:08:41Z 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. cc by-nc (c) Duell, Johannes et al, 2021 http://creativecommons.org/licenses/by-nc/3.0/es/ info:eu-repo/semantics/openAccess Trasplantament d'òrgans Malalties del sistema limfàtic Cèl·lules B Transplantation of organs Lymphatic diseases B cells 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 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion