Clinical benefit of tafasitamab plus lenalidomide in relapsed or refractory diffuse large Bcell lymphoma: real-world data from the EarlyMIND study

Tafasitamab combined with lenalidomide was approved in Europe in 2021 for transplant-ineligible patients with relapsed/ refractory diffuse large B-cell lymphoma. Approval was based on the L-MIND study, which demonstrated a 57.5% overall response rate (ORR), 41.3% complete response (CR) rate, 12.1-month median progression-free survival (PFS), and 33.5-month median overall survival (OS) at 5 years. The multicenter retrospective EarlyMIND study analyzed real-world efficacy and treatment patterns of patients receiving tafasitamab plus lenalidomide for second-line (2L cohort) to fourth-line (3L + 4L cohort) treatment in the French Early Access Program. Outcomes were analyzed overall and according to number of previous lines of treatment. Post hoc analyses were conducted on subgroups based on prognostic factors, performance status, primary refractoriness, cell of origin, and treatment response. Overall, 186 patients were included (2L: N=105; 3L + 4L: N=81). The median age of the patients was 78 years; most patients had early relapsed disease (71.2%), including 60.2% with primary refractory disease. At a median follow-up of 8.2 months, best ORR was 46.8%, with a CR rate of 29%. The ORR was higher in the 2L cohort (50.5%) than in the 3L + 4L cohort (42%). The median PFS and OS were 4.7 and 10 months, respectively, in the overall population, 5.4 and 10.6 months in the 2L cohort, and 3.6 and 8.2 months in the 3L + 4L cohort. Long-lasting responses were observed in patients achieving CR, with median duration of response, PFS, and OS not reached. The median time to CR as best objective response was four cycles, regardless of treatment line. Despite involving a frail population with high-risk disease characteristics, results of this large real-world European retrospective study on tafasitamab plus lenalidomide are encouraging, with almost one third of patients experiencing long-lasting CR.

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Journal
Haematologica
Published
2025-05-15
DOI
https://doi.org/10.3324/haematol.2024.287141
Citations
2
Primary Topic
Lymphoma Diagnosis and Treatment
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article
Field-Weighted Citation Impact
2.94
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article

Clinical benefit of tafasitamab plus lenalidomide in relapsed or refractory diffuse large Bcell lymphoma: real-world data from the EarlyMIND study

Ophélie Cassuto, Thorsten Braun, Jérôme Paillassa, Jérémy Delage et al.
2 citations
Haematologica
Lymphoma Diagnosis and Treatment
2.94
article

Clinical benefit of tafasitamab plus lenalidomide in relapsed or refractory diffuse large Bcell lymphoma: real-world data from the EarlyMIND study

Ophélie Cassuto, Thorsten Braun, Jérôme Paillassa, Jérémy Delage, Adrian Tempescul, Baptiste Delapierre, Gabriel Brisou, Luc‐Matthieu Fornecker, Caroline Serrier, Corinne Haïoun, Camille Villesuzanne, Guillaume Escure, Christophe Nicol, Éric Durot, Charles Herbaux, Laure Lebras, Abderrazak El Yamani, Olivier Tournilhac, Sophie Bernard, Elsa Lestang, Lauris Gastaud, Anne-Sophie Le Bris, Brieuc Chérel, Vadim Ivanov, Frédéric Maloisel, Ludovic Fouillet, Anthony Lévy, Philippe Agapé, Gaëlle Olivier, Laura Jacquemelle
article en
2 citations

Abstract

Tafasitamab combined with lenalidomide was approved in Europe in 2021 for transplant-ineligible patients with relapsed/ refractory diffuse large B-cell lymphoma. Approval was based on the L-MIND study, which demonstrated a 57.5% overall response rate (ORR), 41.3% complete response (CR) rate, 12.1-month median progression-free survival (PFS), and 33.5-month median overall survival (OS) at 5 years. The multicenter retrospective EarlyMIND study analyzed real-world efficacy and treatment patterns of patients receiving tafasitamab plus lenalidomide for second-line (2L cohort) to fourth-line (3L + 4L cohort) treatment in the French Early Access Program. Outcomes were analyzed overall and according to number of previous lines of treatment. Post hoc analyses were conducted on subgroups based on prognostic factors, performance status, primary refractoriness, cell of origin, and treatment response. Overall, 186 patients were included (2L: N=105; 3L + 4L: N=81). The median age of the patients was 78 years; most patients had early relapsed disease (71.2%), including 60.2% with primary refractory disease. At a median follow-up of 8.2 months, best ORR was 46.8%, with a CR rate of 29%. The ORR was higher in the 2L cohort (50.5%) than in the 3L + 4L cohort (42%). The median PFS and OS were 4.7 and 10 months, respectively, in the overall population, 5.4 and 10.6 months in the 2L cohort, and 3.6 and 8.2 months in the 3L + 4L cohort. Long-lasting responses were observed in patients achieving CR, with median duration of response, PFS, and OS not reached. The median time to CR as best objective response was four cycles, regardless of treatment line. Despite involving a frail population with high-risk disease characteristics, results of this large real-world European retrospective study on tafasitamab plus lenalidomide are encouraging, with almost one third of patients experiencing long-lasting CR.

HaematologicaVol. 110(10)
Princess Grace Hospital Centre (MC), Centre Hospitalier Universitaire de Lille (FR), Centre Hospitalier Universitaire Henri-Mondor (FR), Centre Hospitalier de Douai (FR), Assistance Publique Hôpitaux de Marseille (FR), Laval Mayenne Technopole (FR), Centre Hospitalier de Perpignan (FR), Institut de Cancérologie Strasbourg (FR), Institut Européen De La Qualité Totale (FR), Hôpital de la Conception (FR), Assistance Publique – Hôpitaux de Paris (FR), Centre Hospitalier de Saint-Brieuc (FR), Centre Léon Bérard (FR), Centre Hospitalier Universitaire de Reims (FR), Centre Hospitalier de Niort (FR), Centre hospitalier Bretagne Atlantique (FR), Centre Hospitalier Universitaire d'Angers (FR), Centre Hospitalier Universitaire de Caen Normandie (FR), Clinique Saint-Joseph (BE), Centre Hospitalier de la Côte Basque (FR), Centre Hospitalier Universitaire de Clermont-Ferrand (FR), Hôpital Avicenne (FR), Centre Hospitalier Régional Universitaire de Brest (FR), Laboratoire Vision Action Cognition (FR), Centre hospitalier de l'Université Laval (CA), Penn Highlands DuBois (US), Institut Paoli-Calmettes (FR), Centre Hospitalier des Pays de Morlaix (FR), Clinique Ambroise Paré (FR), Centre Hospitalier Saint-Nazaire (FR), Université de Reims Champagne-Ardenne (FR)
Good health and well-being
Openalex Percentile: Top 10%
Lymphoma Diagnosis and Treatment
2.94
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