Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study.


Journal

Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500

Informations de publication

Date de publication:
15 09 2022
Historique:
received: 11 10 2021
revised: 07 01 2022
accepted: 16 05 2022
pubmed: 9 6 2022
medline: 17 9 2022
entrez: 8 6 2022
Statut: ppublish

Résumé

In RE-MIND2 (NCT04697160), patient-level outcomes from the L-MIND study (NCT02399085) of tafasitamab plus lenalidomide were retrospectively compared with patient-level matched observational cohorts treated with National Cancer Care Network (NCCN)/European Society for Medical Oncology (ESMO)-listed systemic therapies for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Data were collected from health records of eligible patients aged ≥18 years with histologically confirmed DLBCL who had received ≥2 systemic therapies for DLBCL (including ≥1 anti-CD20 therapy). Patients from L-MIND were matched with patients from the RE-MIND2 observational cohort using estimated propensity score-based 1:1 nearest-neighbor matching, balanced for nine covariates. The primary analysis compared tafasitamab plus lenalidomide with patients who received any systemic therapy for R/R DLBCL (pooled in one cohort) or bendamustine plus rituximab (BR) or rituximab plus gemcitabine and oxaliplatin (R-GemOx; as two distinct cohorts). The primary endpoint was overall survival (OS). Secondary endpoints included treatment response and time-to-event outcomes. In RE-MIND2, 3,454 patients were enrolled from 200 sites in North America, Europe, and Asia-Pacific. Strictly matched pairs of patients consisted of tafasitamab plus lenalidomide versus systemic therapies pooled (n = 76 pairs), versus BR (n = 75 pairs), and versus R-GemOx (n = 74 pairs). Significantly prolonged OS was reported with tafasitamab plus lenalidomide versus systemic pooled therapies [hazard ratios (HR): 0.55; P = 0.0068], BR (HR: 0.42; P < 0.0001), and R-GemOx (HR: 0.47; P = 0.0003). RE-MIND2, a retrospective observational study, met its primary endpoint, demonstrating prolonged OS with tafasitamab plus lenalidomide versus BR and R-GemOx. See related commentary by Cherng and Westin, p. 3908.

Identifiants

pubmed: 35674661
pii: 704803
doi: 10.1158/1078-0432.CCR-21-3648
pmc: PMC9475241
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Oxaliplatin 04ZR38536J
Rituximab 4F4X42SYQ6
Bendamustine Hydrochloride 981Y8SX18M
Lenalidomide F0P408N6V4
tafasitamab QQA9MLH692

Banques de données

ClinicalTrials.gov
['NCT02399085', 'NCT04697160']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

4003-4017

Subventions

Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States

Commentaires et corrections

Type : CommentIn

Informations de copyright

©2022 The Authors; Published by the American Association for Cancer Research.

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Auteurs

Grzegorz S Nowakowski (GS)

Division of Hematology, Mayo Clinic, Rochester, Minnesota.

Dok Hyun Yoon (DH)

Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.

Anthea Peters (A)

Department of Oncology, University of Alberta, Edmonton, Alberta, Canada.

Patrizia Mondello (P)

Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.

Erel Joffe (E)

Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.

Isabelle Fleury (I)

Institut d'Hématologie-Oncologie-Transplantation Cellulaire, Maisonneuve-Rosemont Hospital, Montréal University, Montreal, Quebec, Canada.

Richard Greil (R)

Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-CCCIT, and Cancer Cluster Salzburg, Salzburg, Austria.

Matthew Ku (M)

Department of Haematology, St Vincent's Hospital and University of Melbourne, Melbourne, Victoria, Australia.

Reinhard Marks (R)

University Hospital Freiburg Internal Medicine I, Freiburg im Breisgau, Germany.

Kibum Kim (K)

Department of Pharmacotherapy, University of Utah, Salt Lake City, Utah.
Department of Pharmacy Systems, Outcomes and Policy, University of Illinois at Chicago, Chicago, Illinois.

Pier Luigi Zinzani (PL)

IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia "Seràgnoli" & Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale Università di Bologna, Bologna, Italy.

Judith Trotman (J)

Haematology Department, Concord Repatriation General Hospital, University of Sydney, Concord, New South Wales, Australia.

Dan Huang (D)

MorphoSys AG, Planegg, Germany.

Eva E Waltl (EE)

MorphoSys AG, Planegg, Germany.

Mark Winderlich (M)

MorphoSys AG, Planegg, Germany.

Nuwan C Kurukulasuriya (NC)

MorphoSys US, Inc., Boston, Massachusetts.

Sumeet Ambarkhane (S)

MorphoSys AG, Planegg, Germany.

Georg Hess (G)

Department of Hematology, Oncology and Pneumology, University Medical Center, Johannes Gutenberg-University, Mainz, Germany.

Gilles Salles (G)

Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.

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Classifications MeSH