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http://hdl.handle.net/2445/180067
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DC Field | Value | Language |
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dc.contributor.author | Duell, Johannes | - |
dc.contributor.author | Maddocks, Kami J. | - |
dc.contributor.author | González Barca, Eva | - |
dc.contributor.author | Jurczak, Wojciech | - |
dc.contributor.author | Liberati, Anna Marina | - |
dc.contributor.author | Vos, Sven de | - |
dc.contributor.author | Nagy, Zsolt | - |
dc.contributor.author | Obr, Aleš | - |
dc.contributor.author | Gaidano, Gianluca | - |
dc.contributor.author | Abrisqueta Costa, Pau | - |
dc.contributor.author | Kalakonda, Nagesh | - |
dc.contributor.author | André, Marc | - |
dc.contributor.author | Dreyling, Martin | - |
dc.contributor.author | Menne, Tobias | - |
dc.contributor.author | Tournilhac, Olivier | - |
dc.contributor.author | Augustin, Marinela | - |
dc.contributor.author | Rosenwald, Andreas | - |
dc.contributor.author | Dirnberger-Hertweck, Maren | - |
dc.contributor.author | Weirather, Johannes | - |
dc.contributor.author | Ambarkhane, Sumeet | - |
dc.contributor.author | Salles, Gilles | - |
dc.date.accessioned | 2021-09-17T08:38:23Z | - |
dc.date.available | 2021-09-17T08:38:23Z | - |
dc.date.issued | 2021-07-01 | - |
dc.identifier.issn | 1592-8721 | - |
dc.identifier.uri | http://hdl.handle.net/2445/180067 | - |
dc.description.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) 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. | - |
dc.format.extent | 10 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Ferrata Storti Foundation | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.3324/haematol.2020.275958 | - |
dc.relation.ispartof | Haematologica, 2021, vol. 106, num. 9, p. 2417-2426 | - |
dc.relation.uri | https://doi.org/10.3324/haematol.2020.275958 | - |
dc.rights | cc by-nc (c) Duell, Johannes et al, 2021 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/3.0/es/ | * |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | Trasplantament d'òrgans | - |
dc.subject.classification | Malalties del sistema limfàtic | - |
dc.subject.classification | Cèl·lules B | - |
dc.subject.other | Transplantation of organs | - |
dc.subject.other | Lymphatic diseases | - |
dc.subject.other | B cells | - |
dc.title | 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 | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2021-09-16T08:08:41Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 34196165 | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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10314-Article Text-75832-2-10-20210830.pdf | 508.58 kB | Adobe PDF | View/Open |
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