Fixed-duration epcoritamab monotherapy induces high response and MRD-negativity rates in elderly patients with newly diagnosed large B-cell lymphoma (LBCL) and comorbidities: Results from EPCORE DLBCL-3

作者：Umberto Vitolo, Johannes Duell, Juan Miguel Bergua Burgués, Wojciech Jurczak, Michał Kwiatek, Marie Maerevoet, Sergio Ortegon Alcaide, David Belada, Won Seog Kim, Richard Greil, Raúl Córdoba, Juan‐Manuel Sancho, David Sibon, Catherine Thieblemont, Takahiro Kumode, Monica Wielgos-Bonvallet, Tony Jiang, Yanli Wang, S. McGoldrick, Evelyn Guo, Franck Morschhauser, Feng Jung Sherida H. Woei-A-Jin · 发表于：Blood · 年份：2025 · DOI：10.1182/blood-2025-63 · 被引用次数：2 · 研究领域：CAR-T cell therapy research、Monoclonal and Polyclonal Antibodies Research、Lymphoma Diagnosis and Treatment

Abstract Introduction: A proportion of newly diagnosed (1L) patients (pts) with LBCL are ineligible for standard curative chemotherapy with full-dose R-CHOP due to age or comorbidities. Alternative regimens (eg, R-mini-CHOP) and other investigational single-agent bispecifics have shown limited efficacy in the 1L setting. EPCORE® DLBCL-3 (NCT05660967) is a 2-stage, phase 2 trial evaluating fixed-duration epcoritamab (epcor), a CD3×CD20 bispecific antibody, as monotherapy or combined with lenalidomide in elderly pts with 1L LBCL and comorbidities. Based on promising efficacy and manageable safety in stage 1, epcor monotherapy was selected for further enrollment in stage 2. Here we report efficacy and safety of epcor monotherapy, including first results from stage 2. Methods: Pts with 1L, CD20+ LBCL ineligible for anthracycline-based chemotherapy due to age ≥80 y or ≥75 y with comorbidities received SC epcor monotherapy: step-up dosing (0.16 mg on cycle 1 day 1 [C1D1]; 0.8 mg on C1D8) followed by 48 mg QW in C1–3 and Q4W in C4–12, for up to 1 y. Cytokine release syndrome (CRS) prophylaxis was mandatory during C1 and continued as needed; adequate hydration was recommended for all Cs. Primary endpoint was complete response (CR) rate per investigator (Lugano criteria). Minimal residual disease (MRD) negativity was assessed as a secondary endpoint in responders by circulating tumor DNA using the exploratory AVENIO assay (cutoff, <1 mutant molecule per mL). Results: As of May ...