Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial

Patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) have poor outcomes (complete response [CR] rates with standard salvage therapy gemcitabine plus oxaliplatin [GemOx], ∼30%; median overall survival [OS], 10 to 13 months). Patients with refractory disease fare worse (CR rate with salvage therapy, 7%; median OS, 6 months). Epcoritamab, a CD3×CD20 bispecific antibody approved for R/R DLBCL after ≥2 therapy lines, has shown promising safety and efficacy in various combinations. We report results from the phase 1b/2 EPCORE NHL-2 trial evaluating epcoritamab plus GemOx in autologous stem cell transplant (ASCT)-ineligible R/R DLBCL. Patients received 48 mg subcutaneous epcoritamab after 2 step-up doses until progression or unacceptable toxicity; GemOx was given once every 2 weeks for 8 doses. The primary end point was overall response rate (ORR). As of 15 December 2023, 103 patients were enrolled (median follow-up, 13.2 months; median age, 72 years). Patients had challenging-to-treat disease: ≥2 prior therapy lines, 62%; prior chimeric antigen receptor T-cell therapy, 28%; primary refractory disease, 52%; refractory to last therapy, 70%. ORR and CR rate were 85% and 61%, respectively. Median duration of CR and OS were 23.6 and 21.6 months, respectively. Common treatment-emergent adverse events were cytopenias and cytokine release syndrome (CRS). CRS events had predictable timing, were primarily low grade (52% overall, 1% grade 3), and resolved without leading to discontinuation. Epcoritamab plus GemOx yielded deep, durable responses and favorable long-term outcomes in ASCT-ineligible R/R DLBCL. This trial was registered at www.clinicaltrials.gov as #NCT04663347.

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Journal
Blood
Published
2025-01-10
DOI
https://doi.org/10.1182/blood.2024026830
Citations
39
Primary Topic
CAR-T cell therapy research
Type
article
Field-Weighted Citation Impact
40.77

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article

Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial

Umberto Vitolo, Andrew J. Steele, Joshua Brody, Kübra Karagoz et al.
39 citations
Blood
CAR-T cell therapy research
40.77
article

Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial

Umberto Vitolo, Andrew J. Steele, Joshua Brody, Kübra Karagoz, Yasmin H. Karimi, Malene Risum, David Belada, Pieternella J. Lugtenburg, Régis Costello, Björn E. Wahlin, Anna Sureda, Marc André, Raúl Córdoba, Marek Trněný, Liwei Wang, Aqeel Abbas, David Lewis, Tony Jiang, Judit Meszaros Jørgensen
article en
39 citations

Abstract

Patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) have poor outcomes (complete response [CR] rates with standard salvage therapy gemcitabine plus oxaliplatin [GemOx], ∼30%; median overall survival [OS], 10 to 13 months). Patients with refractory disease fare worse (CR rate with salvage therapy, 7%; median OS, 6 months). Epcoritamab, a CD3×CD20 bispecific antibody approved for R/R DLBCL after ≥2 therapy lines, has shown promising safety and efficacy in various combinations. We report results from the phase 1b/2 EPCORE NHL-2 trial evaluating epcoritamab plus GemOx in autologous stem cell transplant (ASCT)-ineligible R/R DLBCL. Patients received 48 mg subcutaneous epcoritamab after 2 step-up doses until progression or unacceptable toxicity; GemOx was given once every 2 weeks for 8 doses. The primary end point was overall response rate (ORR). As of 15 December 2023, 103 patients were enrolled (median follow-up, 13.2 months; median age, 72 years). Patients had challenging-to-treat disease: ≥2 prior therapy lines, 62%; prior chimeric antigen receptor T-cell therapy, 28%; primary refractory disease, 52%; refractory to last therapy, 70%. ORR and CR rate were 85% and 61%, respectively. Median duration of CR and OS were 23.6 and 21.6 months, respectively. Common treatment-emergent adverse events were cytopenias and cytokine release syndrome (CRS). CRS events had predictable timing, were primarily low grade (52% overall, 1% grade 3), and resolved without leading to discontinuation. Epcoritamab plus GemOx yielded deep, durable responses and favorable long-term outcomes in ASCT-ineligible R/R DLBCL. This trial was registered at www.clinicaltrials.gov as #NCT04663347.

BloodVol. 145(15)
Charles University (CZ), Genmab (United States) (US), University of Michigan (US), Aarhus University Hospital (DK), Derriford Hospital (GB), Karolinska Institutet (SE), AbbVie (United States) (US), Assistance Publique Hôpitaux de Marseille (FR), Institut Català d'Oncologia (ES), Theories and Approaches of Genomic Complexity (FR), Michigan Medicine (US), Hospital Universitario Fundación Jiménez Díaz (ES), University Hospital Hradec Králové (CZ), Erasmus MC Cancer Institute (NL), Candiolo Cancer Institute (IT), General University Hospital in Prague (CZ), Genmab (Denmark) (DK), UCLouvain (BE), Icahn School of Medicine at Mount Sinai (US)
Bristol-Myers Squibb, Gilead Sciences, Seagen, Servier
Openalex Percentile: Top 0%
CAR-T cell therapy research
40.77
DOIOpen Access PDFOpenAlex
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