Fixed-duration epcoritamab plus R-CHOP in newly diagnosed LBCL with IPI score 3-5: results from the EPCORE NHL-2 trial
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: Patients with newly diagnosed large B-cell lymphoma (LBCL) and International Prognostic Index (IPI) scores ≥3 have inferior outcomes with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). We evaluated efficacy and safety of epcoritamab plus R-CHOP in newly diagnosed LBCL in Arm 1 of the phase 1b/2 EPCORE NHL-2 trial. Adults with CD20+ LBCL and IPI scores 3-5 received R-CHOP (6 cycles) plus epcoritamab for a total of 1 year of treatment. Primary endpoint was investigator-assessed overall response rate (ORR). Key secondary endpoints included complete response (CR) rate, duration of CR (DOCR), progression-free survival (PFS), overall survival (OS), minimal residual disease (MRD) negativity, and safety. Forty-seven patients were treated. Median age was 64 years, 89% had Ann Arbor stage IV, and 53% had bulky disease (≥7 cm). ORR was 98% (95% CI, 89-100) and CR rate 85% (95% CI, 72-94). At median follow-up of 44.2 months, median DOCR, PFS and OS were not reached (NR; 95% CI, NR-NR); estimated 2-year PFS and OS rates were 80% (95% CI, 65-89) and 87% (95% CI, 73-94), respectively. MRD-negativity was achieved in 100% of MRD-evaluable patients. Most common adverse events were neutropenia (74%), anemia (72%), and cytokine release syndrome (CRS; 60%). CRS events were predominantly grade 1-2; all resolved. Epcoritamab plus R-CHOP induced high response rates in patients with newly diagnosed LBCL and IPI scores 3-5. These promising findings support the ongoing phase 3 evaluation of this treatment regimen. This trial was registered at ClinicalTrials.gov (NCT04663347).
Source: Blood
Authors: Lorenzo Falchi, Fritz Offner, Sven de Vos, Joshua D. Brody, Daniel Morillo, Kim Linton, Sylvia Snauwaert, Michael Roost Clausen, Yasmin H. Karimi, Catherine Thieblemont, Umberto Vitolo, Lori A. Leslie, Mayur S. Narkhede, Raúl Córdoba, Toshihiko Oki, Monica Wielgos-Bonvallet, Mina Khoshdeli, Yi Hao, Kimberly Archer, Malene Risum, David Belada
Institutions: Memorial Sloan Kettering Cancer Center, Ghent University Hospital, University of California, Los Angeles, Icahn School of Medicine at Mount Sinai, Hospital Universitario Fundación Jiménez Díaz, University of Manchester, AZ Sint-Jan, Vejle Sygehus, Lillebaelt Hospital, University of Michigan, Assistance Publique – Hôpitaux de Paris, Hôpital Saint-Louis, Candiolo Cancer Institute, University of Alabama at Birmingham, MD Anderson Cancer Center Madrid, AbbVie (United States), Genmab (United States), Genmab (Denmark), University Hospital Hradec Králové
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,500
OpenAlex ID: W7203838853