Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphoma

Epcoritamab is a subcutaneous CD3xCD20 bispecific antibody approved as monotherapy for relapsed/refractory (R/R) follicular lymphoma (FL). We evaluated fixed-duration epcoritamab with rituximab plus lenalidomide (R 2 ) in R/R FL in arm 2 of EPCORE NHL-2 (phase 1b/2). Patients received epcoritamab (2...

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Authors: Falchi, Lorenzo, Sureda, Anna, Lugtenburg, Pieternella J., Leppä, Sirpa, Vermaat, Joost S. P., Nijland, Marcel, Christensen, Jacob Haaber, Vos, Sven de, Holte, Harald, Merryman, Reid W., Abrisqueta, Pau, Linton, Kim M., Sunkersett, Gauri, Hoehn, Daniela, Rana, Ali, Abbas, Aqeel, Marek, Jennifer, Hao, Yi, Steele, Andrew J., Morehouse, Christopher, Hutchings, Martin, Belada, David
Format: article
Status:Published version
Publication Date:2025
Country:España
Institution:Universidad de Oviedo (UNIOVI)
Repository:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/226921
Online Access:https://hdl.handle.net/2445/226921
Access Level:Open access
Keyword:Malalties de la retina
Despreniment de retina
Teràpia sistèmica
Rana, Ali
Retinal diseases
Retinal detachment
Systemic therapy
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spelling Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphomaFalchi, LorenzoSureda, AnnaLugtenburg, Pieternella J. Leppä, SirpaVermaat, Joost S. P.Nijland, MarcelChristensen, Jacob HaaberVos, Sven deHolte, HaraldMerryman, Reid W.Lugtenburg, Pieternella J.Abrisqueta, PauLinton, Kim M.Sunkersett, GauriHoehn, DanielaRana, AliAbbas, AqeelMarek, JenniferHao, YiSteele, Andrew J.Morehouse, ChristopherHutchings, MartinBelada, DavidMalalties de la retinaDespreniment de retinaTeràpia sistèmicaRana, AliRetinal diseasesRetinal detachmentSystemic therapyEpcoritamab is a subcutaneous CD3xCD20 bispecific antibody approved as monotherapy for relapsed/refractory (R/R) follicular lymphoma (FL). We evaluated fixed-duration epcoritamab with rituximab plus lenalidomide (R 2 ) in R/R FL in arm 2 of EPCORE NHL-2 (phase 1b/2). Patients received epcoritamab (2 step-up doses, then 48-mg full doses) for up to 2 years, and R 2 for up to 12 cycles (28 days per cycle). The primary end point was overall response rate (ORR) per investigator assessment (Lugano criteria). As of 21 September 2024, 108 patients received >= 1 epcoritamab dose in expansion (median follow-up, 28.2 months). Median age was 65 years; 57% had 1 previous line of therapy. ORR and complete response (CR) rate were 96% and 88%, respectively; CR rates in patients with high-risk features were 90% (primary refractory), 82% (refractory to anti-CD20 and an alkylating agent), and 83% (disease progression within 24 months of first-line therapy). Two-year estimates for remaining in CR, progression-free survival, overall survival, and not starting next antilymphoma therapy were 82%, 76%, 90%, and 84%, respectively. Minimal residual disease negativity was observed in 86% of evaluable patients (clonoSEQ assay). Common treatment-emergent adverse events (TEAEs) included neutropenia (65%), COVID-19 (59%), and cytokine release syndrome (CRS; 51%). Grade >= 3 TEAEs occurred in 87% of patients; 5 had grade 5 TEAEs (all COVID-19). CRS events were mostly low grade (grade 1, 38%; grade 2, 11%; grade 3, 2%), all resolved, and none led to epcoritamab discontinuation. Fixed-duration epcoritamab plus R 2 demonstrated deep, durable responses with manageable safety and favorable outcomes in R/R FL, irrespective of risk features. American Society of Hematology2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/226921Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Dipòsit Digital de la UBinstname:Universidad de Oviedo (UNIOVI)InglésReproducció del document publicat a: https://doi.org/10.1182/blood.2025029909Blood, 2025, vol. 146, num. 22, 2629-2640https://doi.org/10.1182/blood.2025029909cc-by-nc-nd (c) American Society of Hematology, 2025https://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/2269212026-05-27T06:46:51Z
dc.title.none.fl_str_mv Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphoma
title Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphoma
spellingShingle Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphoma
Falchi, Lorenzo
Malalties de la retina
Despreniment de retina
Teràpia sistèmica
Rana, Ali
Retinal diseases
Retinal detachment
Systemic therapy
title_short Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphoma
title_full Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphoma
title_fullStr Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphoma
title_full_unstemmed Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphoma
title_sort Fixed-duration epcoritamab plus R2 drives favorable outcomes in relapsed or refractory follicular lymphoma
dc.creator.none.fl_str_mv Falchi, Lorenzo
Sureda, Anna
Lugtenburg, Pieternella J.
Leppä, Sirpa
Vermaat, Joost S. P.
Nijland, Marcel
Christensen, Jacob Haaber
Vos, Sven de
Holte, Harald
Merryman, Reid W.
Lugtenburg, Pieternella J.
Abrisqueta, Pau
Linton, Kim M.
Sunkersett, Gauri
Hoehn, Daniela
Rana, Ali
Abbas, Aqeel
Marek, Jennifer
Hao, Yi
Steele, Andrew J.
Morehouse, Christopher
Hutchings, Martin
Belada, David
author Falchi, Lorenzo
author_facet Falchi, Lorenzo
Sureda, Anna
Lugtenburg, Pieternella J.
Leppä, Sirpa
Vermaat, Joost S. P.
Nijland, Marcel
Christensen, Jacob Haaber
Vos, Sven de
Holte, Harald
Merryman, Reid W.
Lugtenburg, Pieternella J.
Abrisqueta, Pau
Linton, Kim M.
Sunkersett, Gauri
Hoehn, Daniela
Rana, Ali
Abbas, Aqeel
Marek, Jennifer
Hao, Yi
Steele, Andrew J.
Morehouse, Christopher
Hutchings, Martin
Belada, David
author_role author
author2 Sureda, Anna
Lugtenburg, Pieternella J.
Leppä, Sirpa
Vermaat, Joost S. P.
Nijland, Marcel
Christensen, Jacob Haaber
Vos, Sven de
Holte, Harald
Merryman, Reid W.
Lugtenburg, Pieternella J.
Abrisqueta, Pau
Linton, Kim M.
Sunkersett, Gauri
Hoehn, Daniela
Rana, Ali
Abbas, Aqeel
Marek, Jennifer
Hao, Yi
Steele, Andrew J.
Morehouse, Christopher
Hutchings, Martin
Belada, David
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Malalties de la retina
Despreniment de retina
Teràpia sistèmica
Rana, Ali
Retinal diseases
Retinal detachment
Systemic therapy
topic Malalties de la retina
Despreniment de retina
Teràpia sistèmica
Rana, Ali
Retinal diseases
Retinal detachment
Systemic therapy
description Epcoritamab is a subcutaneous CD3xCD20 bispecific antibody approved as monotherapy for relapsed/refractory (R/R) follicular lymphoma (FL). We evaluated fixed-duration epcoritamab with rituximab plus lenalidomide (R 2 ) in R/R FL in arm 2 of EPCORE NHL-2 (phase 1b/2). Patients received epcoritamab (2 step-up doses, then 48-mg full doses) for up to 2 years, and R 2 for up to 12 cycles (28 days per cycle). The primary end point was overall response rate (ORR) per investigator assessment (Lugano criteria). As of 21 September 2024, 108 patients received >= 1 epcoritamab dose in expansion (median follow-up, 28.2 months). Median age was 65 years; 57% had 1 previous line of therapy. ORR and complete response (CR) rate were 96% and 88%, respectively; CR rates in patients with high-risk features were 90% (primary refractory), 82% (refractory to anti-CD20 and an alkylating agent), and 83% (disease progression within 24 months of first-line therapy). Two-year estimates for remaining in CR, progression-free survival, overall survival, and not starting next antilymphoma therapy were 82%, 76%, 90%, and 84%, respectively. Minimal residual disease negativity was observed in 86% of evaluable patients (clonoSEQ assay). Common treatment-emergent adverse events (TEAEs) included neutropenia (65%), COVID-19 (59%), and cytokine release syndrome (CRS; 51%). Grade >= 3 TEAEs occurred in 87% of patients; 5 had grade 5 TEAEs (all COVID-19). CRS events were mostly low grade (grade 1, 38%; grade 2, 11%; grade 3, 2%), all resolved, and none led to epcoritamab discontinuation. Fixed-duration epcoritamab plus R 2 demonstrated deep, durable responses with manageable safety and favorable outcomes in R/R FL, irrespective of risk features.
publishDate 2025
dc.date.none.fl_str_mv 2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/226921
url https://hdl.handle.net/2445/226921
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1182/blood.2025029909
Blood, 2025, vol. 146, num. 22, 2629-2640
https://doi.org/10.1182/blood.2025029909
dc.rights.none.fl_str_mv cc-by-nc-nd (c) American Society of Hematology, 2025
https://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by-nc-nd (c) American Society of Hematology, 2025
https://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv American Society of Hematology
publisher.none.fl_str_mv American Society of Hematology
dc.source.none.fl_str_mv Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
reponame:Dipòsit Digital de la UB
instname:Universidad de Oviedo (UNIOVI)
instname_str Universidad de Oviedo (UNIOVI)
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869402587803942912
score 15,811543

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