Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial.
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Embargo End Date
ICR Authors
Authors
Thieblemont, C
Karimi, YH
Ghesquieres, H
Cheah, CY
Clausen, MR
Cunningham, D
Jurczak, W
Do, YR
Gasiorowski, R
Lewis, DJ
Kim, TM
van der Poel, M
Poon, ML
Feldman, T
Linton, KM
Sureda, A
Hutchings, M
Dinh, MH
Kilavuz, N
Soong, D
Mark, T
Sacchi, M
Phillips, T
Lugtenburg, PJ
Karimi, YH
Ghesquieres, H
Cheah, CY
Clausen, MR
Cunningham, D
Jurczak, W
Do, YR
Gasiorowski, R
Lewis, DJ
Kim, TM
van der Poel, M
Poon, ML
Feldman, T
Linton, KM
Sureda, A
Hutchings, M
Dinh, MH
Kilavuz, N
Soong, D
Mark, T
Sacchi, M
Phillips, T
Lugtenburg, PJ
Document Type
Journal Article
Date
2024-12-01
Date Accepted
2024-09-05
Abstract
Primary results (median follow-up, 10.7 months) from the pivotal EPCORE® 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).
Citation
Leukemia, 2024, 38 (12), pp. 2653 - 2662
Source Title
Leukemia
Publisher
SPRINGERNATURE
ISSN
0887-6924
eISSN
1476-5551
Collections
Research Team
Medicine (RMH)