Cargando…

RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma

ABSTRACT: RE-MIND2 (NCT04697160) compared patient outcomes from the L-MIND (NCT02399085) trial of tafasitamab+lenalidomide with those of patients treated with other therapies for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are autologous stem cell transplant ineligible. We pr...

Descripción completa

Detalles Bibliográficos
Autores principales: Nowakowski, Grzegorz S., Yoon, Dok Hyun, Mondello, Patrizia, Joffe, Erel, Peters, Anthea, Fleury, Isabelle, Greil, Richard, Ku, Matthew, Marks, Reinhard, Kim, Kibum, Zinzani, Pier Luigi, Trotman, Judith, Sabatelli, Lorenzo, Waltl, Eva E., Winderlich, Mark, Sporchia, Andrea, Kurukulasuriya, Nuwan C., Cordoba, Raul, Hess, Georg, Salles, Gilles
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10261238/
https://www.ncbi.nlm.nih.gov/pubmed/37171597
http://dx.doi.org/10.1007/s00277-023-05196-4
_version_ 1785057908707295232
author Nowakowski, Grzegorz S.
Yoon, Dok Hyun
Mondello, Patrizia
Joffe, Erel
Peters, Anthea
Fleury, Isabelle
Greil, Richard
Ku, Matthew
Marks, Reinhard
Kim, Kibum
Zinzani, Pier Luigi
Trotman, Judith
Sabatelli, Lorenzo
Waltl, Eva E.
Winderlich, Mark
Sporchia, Andrea
Kurukulasuriya, Nuwan C.
Cordoba, Raul
Hess, Georg
Salles, Gilles
author_facet Nowakowski, Grzegorz S.
Yoon, Dok Hyun
Mondello, Patrizia
Joffe, Erel
Peters, Anthea
Fleury, Isabelle
Greil, Richard
Ku, Matthew
Marks, Reinhard
Kim, Kibum
Zinzani, Pier Luigi
Trotman, Judith
Sabatelli, Lorenzo
Waltl, Eva E.
Winderlich, Mark
Sporchia, Andrea
Kurukulasuriya, Nuwan C.
Cordoba, Raul
Hess, Georg
Salles, Gilles
author_sort Nowakowski, Grzegorz S.
collection PubMed
description ABSTRACT: RE-MIND2 (NCT04697160) compared patient outcomes from the L-MIND (NCT02399085) trial of tafasitamab+lenalidomide with those of patients treated with other therapies for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are autologous stem cell transplant ineligible. We present outcomes data for three pre-specified treatments not assessed in the primary analysis. Data were retrospectively collected from sites in North America, Europe, and the Asia Pacific region. Patients were aged ≥18 years with histologically confirmed DLBCL and received ≥2 systemic therapies for DLBCL (including ≥1 anti-CD20 therapy). Patients enrolled in the observational and L-MIND cohorts were matched using propensity score-based 1:1 nearest-neighbor matching, balanced for six covariates. Tafasitamab+lenalidomide was compared with polatuzumab vedotin+bendamustine+rituximab (pola-BR), rituximab+lenalidomide (R2), and CD19-chimeric antigen receptor T-cell (CAR-T) therapies. The primary endpoint was overall survival (OS). Secondary endpoints included treatment response and progression-free survival. From 200 sites, 3,454 patients were enrolled in the observational cohort. Strictly matched patient pairs consisted of tafasitamab+lenalidomide versus pola-BR (n = 24 pairs), versus R2 (n = 33 pairs), and versus CAR-T therapies (n = 37 pairs). A significant OS benefit was observed with tafasitamab+lenalidomide versus pola-BR (HR: 0.441; p = 0.034) and R2 (HR: 0.435; p = 0.012). Comparable OS was observed in tafasitamab+lenalidomide and CAR-T cohorts (HR: 0.953, p = 0.892). Tafasitamab+lenalidomide appeared to improve survival outcomes versus pola-BR and R2, and comparable outcomes were observed versus CAR-T. Although based on limited patient numbers, these data may help to contextualize emerging therapies for R/R DLBCL. CLINICAL TRIAL REGISTRATION: NCT04697160 (January 6, 2021) SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00277-023-05196-4.
format Online
Article
Text
id pubmed-10261238
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Springer Berlin Heidelberg
record_format MEDLINE/PubMed
spelling pubmed-102612382023-06-15 RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma Nowakowski, Grzegorz S. Yoon, Dok Hyun Mondello, Patrizia Joffe, Erel Peters, Anthea Fleury, Isabelle Greil, Richard Ku, Matthew Marks, Reinhard Kim, Kibum Zinzani, Pier Luigi Trotman, Judith Sabatelli, Lorenzo Waltl, Eva E. Winderlich, Mark Sporchia, Andrea Kurukulasuriya, Nuwan C. Cordoba, Raul Hess, Georg Salles, Gilles Ann Hematol Original Article ABSTRACT: RE-MIND2 (NCT04697160) compared patient outcomes from the L-MIND (NCT02399085) trial of tafasitamab+lenalidomide with those of patients treated with other therapies for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are autologous stem cell transplant ineligible. We present outcomes data for three pre-specified treatments not assessed in the primary analysis. Data were retrospectively collected from sites in North America, Europe, and the Asia Pacific region. Patients were aged ≥18 years with histologically confirmed DLBCL and received ≥2 systemic therapies for DLBCL (including ≥1 anti-CD20 therapy). Patients enrolled in the observational and L-MIND cohorts were matched using propensity score-based 1:1 nearest-neighbor matching, balanced for six covariates. Tafasitamab+lenalidomide was compared with polatuzumab vedotin+bendamustine+rituximab (pola-BR), rituximab+lenalidomide (R2), and CD19-chimeric antigen receptor T-cell (CAR-T) therapies. The primary endpoint was overall survival (OS). Secondary endpoints included treatment response and progression-free survival. From 200 sites, 3,454 patients were enrolled in the observational cohort. Strictly matched patient pairs consisted of tafasitamab+lenalidomide versus pola-BR (n = 24 pairs), versus R2 (n = 33 pairs), and versus CAR-T therapies (n = 37 pairs). A significant OS benefit was observed with tafasitamab+lenalidomide versus pola-BR (HR: 0.441; p = 0.034) and R2 (HR: 0.435; p = 0.012). Comparable OS was observed in tafasitamab+lenalidomide and CAR-T cohorts (HR: 0.953, p = 0.892). Tafasitamab+lenalidomide appeared to improve survival outcomes versus pola-BR and R2, and comparable outcomes were observed versus CAR-T. Although based on limited patient numbers, these data may help to contextualize emerging therapies for R/R DLBCL. CLINICAL TRIAL REGISTRATION: NCT04697160 (January 6, 2021) SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00277-023-05196-4. Springer Berlin Heidelberg 2023-05-12 2023 /pmc/articles/PMC10261238/ /pubmed/37171597 http://dx.doi.org/10.1007/s00277-023-05196-4 Text en © The Author(s) 2023, corrected publication 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Article
Nowakowski, Grzegorz S.
Yoon, Dok Hyun
Mondello, Patrizia
Joffe, Erel
Peters, Anthea
Fleury, Isabelle
Greil, Richard
Ku, Matthew
Marks, Reinhard
Kim, Kibum
Zinzani, Pier Luigi
Trotman, Judith
Sabatelli, Lorenzo
Waltl, Eva E.
Winderlich, Mark
Sporchia, Andrea
Kurukulasuriya, Nuwan C.
Cordoba, Raul
Hess, Georg
Salles, Gilles
RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma
title RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma
title_full RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma
title_fullStr RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma
title_full_unstemmed RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma
title_short RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma
title_sort re-mind2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-br), car-t therapies, and lenalidomide/rituximab (r2) based on real-world data in patients with relapsed/refractory diffuse large b-cell lymphoma
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10261238/
https://www.ncbi.nlm.nih.gov/pubmed/37171597
http://dx.doi.org/10.1007/s00277-023-05196-4
work_keys_str_mv AT nowakowskigrzegorzs remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT yoondokhyun remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT mondellopatrizia remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT joffeerel remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT petersanthea remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT fleuryisabelle remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT greilrichard remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT kumatthew remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT marksreinhard remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT kimkibum remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT zinzanipierluigi remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT trotmanjudith remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT sabatellilorenzo remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT waltlevae remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT winderlichmark remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT sporchiaandrea remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT kurukulasuriyanuwanc remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT cordobaraul remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT hessgeorg remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma
AT sallesgilles remind2comparativeeffectivenessoftafasitamabpluslenalidomideversuspolatuzumabvedotinbendamustinerituximabpolabrcarttherapiesandlenalidomiderituximabr2basedonrealworlddatainpatientswithrelapsedrefractorydiffuselargebcelllymphoma