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Efficacy and safety of epcoritamab in relapsed or refractory large B-cell lymphoma: 3-year update from the EPCORE NHL-1 trial
Journal article   Open access   Peer reviewed

Efficacy and safety of epcoritamab in relapsed or refractory large B-cell lymphoma: 3-year update from the EPCORE NHL-1 trial

Yasmin H Karimi, Chan Y Cheah, Michael Roost Clausen, David Cunningham, Umar Farooq, Tatyana Feldman, Herve Ghesquieres, Wojciech Jurczak, Kim M Linton, Tycel Phillips, …
Annals of hematology, Vol.105(3), 79
02/04/2026
DOI: 10.1007/s00277-026-06798-4
PMCID: PMC12868022
PMID: 41634395
url
https://doi.org/10.1007/s00277-026-06798-4View
Published (Version of record) Open Access

Abstract

Epcoritamab, a CD3xCD20 bispecific antibody, resulted in deep, durable responses with a manageable safety profile in patients with relapsed/refractory large B-cell lymphoma (LBCL) in EPCORE NHL-1 (NCT03625037). We report results from a 3-year follow-up. Adults with relapsed/refractory LBCL received epcoritamab until progressive disease or unacceptable toxicity. The primary endpoint was overall response rate (ORR). Median age was 64.0 years, 39% of patients received prior CAR T-cell treatment, and 75% were refractory to ≥ 2 consecutive lines of treatment. As of May 3, 2024 (median follow-up 37.1 months [range, 0.3-45.5]), ORR was 59% and complete response (CR) rate 41% by investigator assessment. Median duration of response was 20.8 months (95% confidence interval [CI], 13.0-32.0). Median duration of CR was 36.1 months (20.2-not reached [NR]); the longest ongoing CR was > 43 months. Median progression-free survival was 4.2 months (95% CI, 2.8-5.5) in all patients and 37.3 months (26.0-NR) in patients with CR. Median overall survival was 18.5 months (95% CI, 11.7-27.7) in all patients and NR in patients with CR. Of 119 patients evaluable for minimal residual disease (MRD) assessments, 54 (45%) were MRD-negative at any time during the study. Most common adverse events were cytokine release syndrome (51%), fatigue (25%), and pyrexia (25%), with no new safety signals. Grade 1, 2, and 3 infections occurred in 23%, 34%, and 24% of patients, respectively. The durability of responses and prolonged survival in complete responders suggest long-term disease-free survival with epcoritamab in these patients with relapsed/refractory LBCL.
 Adult Aged Aged, 80 and over Antibodies, Bispecific - administration & dosage Antibodies, Bispecific - adverse effects Antibodies, Bispecific - therapeutic use Antineoplastic Agents, Immunological - adverse effects Antineoplastic Agents, Immunological - therapeutic use Female Follow-Up Studies Humans Lymphoma, Large B-Cell, Diffuse - drug therapy Lymphoma, Large B-Cell, Diffuse - mortality Male Middle Aged Neoplasm Recurrence, Local - drug therapy Recurrence Treatment Outcome

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