Brody, Joshua D.Jørgensen, JuditBelada, DavidCostello, RegisTrněný, MarekVitolo, UmbertoLewis, David JohnKarimi, Yasmin H.Sureda, AnnaAndré, MarcWahlin, Björn E.Lugtenburg, Pieternella J.Jiang, TonyKaragoz, KubraSteele, Andrew J.Abbas, AqeelWang, LiweiRisum, MaleneCórdoba, Raúl2025-07-162025-07-162025-12-010006-4971https://hdl.handle.net/2445/222293Patients 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.11 p.application/pdfengcc-by-nc-nd (c) American Society of Hematology, 2025http://creativecommons.org/licenses/by-nc-nd/3.0/es/Persones gransAutoanticossosMedicaments antineoplàsticsOlder peopleAutoantibodiesAntineoplastic agentsinfo:eu-repo/semantics/article7591712025-07-16info:eu-repo/semantics/openAccess39792928