Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial
Language English Country United States Media print
Document type Journal Article, Clinical Trial, Phase II, Multicenter Study, Clinical Trial, Phase I
PubMed
39792928
PubMed Central
PMC12000653
DOI
10.1182/blood.2024026830
PII: 535030
Knihovny.cz E-resources
- MeSH
- Deoxycytidine * analogs & derivatives administration & dosage adverse effects therapeutic use MeSH
- Lymphoma, Large B-Cell, Diffuse * drug therapy mortality pathology MeSH
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Oxaliplatin administration & dosage adverse effects MeSH
- Antibodies, Bispecific * administration & dosage adverse effects therapeutic use MeSH
- Antineoplastic Combined Chemotherapy Protocols * therapeutic use adverse effects administration & dosage MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Salvage Therapy MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase I MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Names of Substances
- Deoxycytidine * MeSH
- Oxaliplatin MeSH
- Antibodies, Bispecific * MeSH
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.
Biostatistics Genmab Plainsboro NJ
Clinical Science Genmab Plainsboro NJ
Department of Haematology Aarhus University Hospital Aarhus Denmark
Department of Internal Medicine Icahn School of Medicine at Mount Sinai New York NY
Department of Medical Oncology Candiolo Cancer Institute FPO IRCCS Turin Italy
Division of Haematology Department of Medicine at Huddinge Karolinska Institutet Stockholm Sweden
Medical Genmab Copenhagen Denmark
Oncology Clinical Development AbbVie North Chicago IL
Translational Data Science Genmab Plainsboro NJ
Translational Medicine Genmab Plainsboro NJ
University of Michigan Division of Hematology and Oncology Ann Arbor MI
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ClinicalTrials.gov
NCT04663347
