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Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial

delete2024-09-25
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C
Catherine Thiéblemont *
Y
Yasmin Karimi
H
Hervé Ghesquières
C
Chan Y. Cheah
M
Michael Roost Clausen
D
David Cunningham
W
Wojciech Jurczak
Y
Young Rok
R
Robin Gasiorowski
D
David Lewis
T
Tae Min Kim
M
Marjolein van der Poel
M
Michelle Poon
T
Tatyana Feldman
K
Kim Linton
A
Anna Sureda
M
Martin Hutchings
M
Minh H Dinh
N
Nurgul Kilavuz
D
David Soong
T
Thomas Mark
M
Mariana Sacchi
T
Tycel Phillips
P
Pieternella J. Lugtenburg
DOI:10.1038/s41375-024-02410-8delete
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Abstract

Abstract

En 中文
Primary results (median follow-up, 10.7 months) from the pivotal EPCORE (R) NHL-1 study in relapsed or refractory (R/R) large B-cell lymphoma (LBCL) demonstrated deep, durable responses with epcoritamab, a CD3xCD20 bispecific antibody, when used as monotherapy. We report long-term efficacy and safety results in patients with LBCL (N = 157; 25.1-month median follow-up). As of April 21, 2023, overall response rate was 63.1% and complete response (CR) rate was 40.1%. Estimated 24-month progression-free survival (PFS) and overall survival (OS) rates were 27.8% and 44.6%, respectively. An estimated 64.2% of complete responders remained in CR at 24 months. Estimated 24-month PFS and OS rates among complete responders were 65.1% and 78.2%, respectively. Of 119 minimal residual disease (MRD)-evaluable patients, 45.4% had MRD negativity, which correlated with longer PFS and OS. CR rates were generally consistent across predefined subgroups: 36% prior chimeric antigen receptor (CAR) T-cell therapy, 32% primary refractory disease, and 37% International Prognostic Index >= 3. The most common treatment-emergent adverse events were cytokine release syndrome (51.0%), pyrexia (24.8%), fatigue (24.2%), and neutropenia (23.6%). These results underscore the long-term benefit of epcoritamab for treating R/R LBCL with deep responses across subgroups, including patients with hard-to-treat disease and expected poor prognosis (ClinicalTrials.gov Registration: NCT03625037).
Keywords:
HEALTH-ORGANIZATION CLASSIFICATION
TAFASITAMAB PLUS LENALIDOMIDE
NON-HODGKIN-LYMPHOMA
SINGLE-ARM
OPEN-LABEL
MULTICENTER
OUTCOMES
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