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.

Humans Adolescent Adult Rituximab Lenalidomide Bendamustine Hydrochloride / therapeutic use Receptors, Chimeric Antigen Retrospective Studies Lymphoma, Non-Hodgkin / drug therapy Lymphoma, Large B-Cell, Diffuse / drug therapy

DLBCL Lenalidomide Real-world Relapsed/Refractory Tafasitamab

Journal

Annals of hematology

ISSN: 1432-0584

Titre abrégé: Ann Hematol

Pays: Germany

ID NLM: 9107334

Informations de publication

Date de publication:
Jul 2023

Historique:

received: 25 05 2022

accepted: 23 03 2023

medline: 14 6 2023

pubmed: 12 5 2023

entrez: 12 5 2023

Statut: ppublish

Résumé

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).

Identifiants

DOI: 10.1007/s00277-023-05196-4 PMID: 37171597 PMC: PMC10261238

pubmed: 37171597

doi: 10.1007/s00277-023-05196-4

pii: 10.1007/s00277-023-05196-4

pmc: PMC10261238

doi:

Substances chimiques

Rituximab 4F4X42SYQ6

polatuzumab vedotin KG6VO684Z6

tafasitamab QQA9MLH692

Lenalidomide F0P408N6V4

Bendamustine Hydrochloride 981Y8SX18M

Receptors, Chimeric Antigen 0

Banques de données

ClinicalTrials.gov

['NCT04697160']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

1773-1787

Subventions

Organisme : NCI NIH HHS

ID : P30 CA008748

Pays : United States

Commentaires et corrections

Type : ErratumIn

Informations de copyright

Références

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