primary Phase 3 results from the epcore FL-1 trial of epcoritamab with rituximab and lenalidomide (R2) versus R2 for relapsed or refractory follicular lymphoma

作者：Lorenzo Falchi, Marcel Nijland, Huiqiang Huang, Kim Linton, John F. Seymour, Rong Tao, Michał Kwiatek, Abel Costa, Theodoros Vassilakopoulos, Richard Greil, Ana Jiménez Ubieto, Shane Gangatharan, Ohad Benjamini, Catherine Thiéblemont, Alessandra Tucci, Anna Elinder-Camburn, Arpád Illés, Jan Novák, Miguel Arturo Pavlovsky, Andrew McDonald, Dok Hyun Yoon, Yuko Mishima, Gauri Sunkersett, Jian Mei, Nabanita Mukherjee, Feng Zhu, Elena Favaro, Franck Morschhauser · 发表于：Blood · 年份：2025 · DOI：10.1182/blood-2025-466 · 被引用次数：2 · 研究领域：CAR-T cell therapy research、Monoclonal and Polyclonal Antibodies Research、Neuroblastoma Research and Treatments

Abstract INTRODUCTION: Patients (pts) with relapsed/refractory (R/R) follicular lymphoma FL have limited second line (2L) treatment options, rituximab and lenalidomideR2being the only 2L alternative to immunochemotherapy-based therapy. Epcoritamab (epcor), a CD3xCD20 bispecific antibody, is approved for R/R FL as monotherapy after ≥2 lines of systemic therapy. Epcor plus R2 (E+R2) is a chemotherapy-free regimen which showed promising antitumor activity (97% overall response rate [ORR], 87% complete response [CR] rate) and manageable safety in the phase 1b/2 EPCORE NHL-2 trial (Falchi et al, ASH 2024). We report the results of EPCORE FL-1: the first global phase 3 trial of fixed-duration bispecific antibody regimen E+R2 vs R2 in pts with 2L+ FL (NCT05409066). METHODS: Adults with CD20+ FL R/R after at least 1 prior line, who met GELF criteria, were randomized to receive E+R2or R2for up to 12 cycles (C). Subcutaneous epcor was administered using a 2-step-up dose (2SUD) or 3-step-up dose (3SUD) regimen and full doses (48mg) thereafter. Epcor was administered weekly in C1–3 and q28 days from C4–12. Intravenous rituximab was administered weekly in C1 and q28 days during C2–5. Oral lenalidomide was administered daily from day 1–21 during C1–12. Pts received mandatory CRS prophylaxis in C1. Dual primary endpoints were ORR and progression-free survival (PFS) assessed by independent review committee per Lugano criteria. Secondary endpoints included CR rate (CRR), overall survival (OS)...