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Dp074 | Epcoritamab Monotherapy Demonstrates Deep and Durable Responses at 3-year Follow-up in Patients With Relapsed/refractory Follicular Lymphoma

Year: 2025
Type: article
Abstract: Introduction: Epcoritamab (epcor), a subcutaneous CD3xCD20 bispecific antibody, is approved for relapsed/refractory (R/R) follicular lymphoma (FL) after ≥2 prior lines of therapy (3L+) based on EPCORE NHL-1 FL (NCT03625037; US/EU) and NHL-3 FL (NCT04542824; Japan) expansion cohorts (EXP) results. We report 3-y follow-up (FU) from EXP and updated NHL-1 cycle (C) 1 optimization cohort (OPT) results for epcor monotherapy in patients (pts) with 3L+ FL. Methods: Pts with 3L+ CD20+ R/R FL grade (G) 1–3A received epcor in 28-d Cs until disease progression (PD) or unacceptable toxicity. NHL-1 (N=128) and NHL-3 (N=21) EXP were pooled for diversity; OPT is reported separately. Primary endpoints were efficacy (EXP) and CRS incidence and severity (OPT); secondary endpoints were MRD (ClonoSeq®) negativity (EXP), response rates (OPT), and safety (EXP/OPT). Results: As of Dec 2024, median FU was 35 mo and 15.5 mo, and median treatment (tx) duration was 9.7 and 11.4 mo, in EXP (N=149) and OPT (N=86), respectively. Pts had a median of 3 prior lines of tx and high-risk disease features. In pooled EXP, ORR/CRR were 84.6%/67.1% (Table). With longer-term FU, safety from EXP was consistent with previous reports. In EXP, conducted during the COVID-19 pandemic peak, 34.9% of pts had G3-4 infections (18.1% COVID-19) and 7.4% had G5 events (5.4% COVID-19); 28% of pts discontinued (d/c) tx due to tx-emergent adverse events (TEAEs; 12.1% COVID-19). Among 35 pts on ≥2y of tx, 14.3% had G3 or higher infections. In OPT, updated ORR/CRR were 91.9%/73.3%; time-to-event endpoint data were still maturing, with 93% of pts alive. Safety from OPT remained unchanged from prior reports of only low-grade CRS (39.5% G1, 9.3% G2) and no ICANS. In OPT, conducted post COVID-19 pandemic peak, 20.9% of pts had G3-4 infections (7.0% COVID-19, all G3); 1 pt had G5 TEAE of viral respiratory tract infection. TEAEs leading to tx d/c occurred in 11% (1.2% COVID-19). Conclusions: Epcor monotherapy demonstrated deep, durable responses and manageable safety with no new safety signals at 3y in a large and diversified 3L+ FL global population. OPT cohort response rates were consistent with those from EXP and confirmed the favorable safety profile of epcor, with reduced rates and severity of CRS/ICANS with 3-SUD regimen, and lower post-pandemic COVID-19 rates. ©2025 European Hematology Association. Reused with permission. This abstract was accepted at the 2025 EHA Annual Meeting.
Authors: M. Frascione, U. Vitolo, W. Jurczak, P.J. Lugtenburg, E. Gyan, J. C. Chavez, A. Sureda, J. Haaber Christensen, H. Tilly, R. Cordoba, D. J. Lewis, M. Hutchings, M. Roost Clausen, J-M. Sancho, T. Cochrane, S. Leppä, M.E. D. Chamuleau, C. Thieblemont, K. Izutsu, N. Fukuhara, P. F. Caimi, Y. H. Karimi, C. andreadis, J.M. Vose, E. Favaro, P. Patah, M. Geybels, I. Altintas, C. Morehouse, K.M. Linton
Institutions: Candiolo Cancer Institute, Erasmus MC Cancer Institute, Inserm, Centre Hospitalier Universitaire de Tours, Clinical Investigation Center Plurithematic Tours, Moffitt Cancer Center, Institut d'Investigació Biomédica de Bellvitge, Institut Català d'Oncologia, Odense University Hospital, Centre Henri Becquerel, Université de Rouen Normandie, Hospital Universitario Fundación Jiménez Díaz, Derriford Hospital, University Hospitals Plymouth NHS Trust, University of Copenhagen, Rigshospitalet, Vejle Sygehus, Hospital Universitari Germans Trias i Pujol, Gold Coast Hospital, Gold Coast Health, University of Helsinki, Helsinki University Hospital, Hovon, Amsterdam University Medical Centers, Amsterdam UMC Location Vrije Universiteit Amsterdam, Assistance Publique – Hôpitaux de Paris, Hôpital Saint-Louis, National Cancer Center Hospital, Tohoku University Hospital, Cleveland Clinic, University of Michigan, University of California, San Francisco, University of Nebraska Medical Center, AbbVie (United States), University of Manchester, The Christie NHS Foundation Trust, Cancer Research UK Manchester Centre
Language: English
Field: Medicine
Open Access status: green
OpenAlex ID: W7093122185
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