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Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial
JD. Brody, J. Jørgensen, D. Belada, R. Costello, M. Trněný, U. Vitolo, DJ. Lewis, YH. Karimi, A. Sureda, M. André, BE. Wahlin, PJ. Lugtenburg, T. Jiang, K. Karagoz, AJ. Steele, A. Abbas, L. Wang, M. Risum, R. Cordoba
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, klinické zkoušky, fáze II, multicentrická studie, klinické zkoušky, fáze I
NLK
Open Access Digital Library
od 1946-01-01
Open Access Digital Library
od 1946-01-01
ROAD: Directory of Open Access Scholarly Resources
PubMed
39792928
DOI
10.1182/blood.2024026830
Knihovny.cz E-zdroje
- MeSH
- deoxycytidin * analogy a deriváty aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- difúzní velkobuněčný B-lymfom * farmakoterapie mortalita patologie MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- oxaliplatin aplikace a dávkování škodlivé účinky MeSH
- protilátky bispecifické * aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- protokoly protinádorové kombinované chemoterapie * terapeutické užití škodlivé účinky aplikace a dávkování MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- záchranná terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze I MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie 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
Citace poskytuje Crossref.org
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