C012 | Novel Analysis of Results From the Pivotal Epcore Nhl-1 Study: Outcomes in Patients With Relapsed/refractory Large B-cell Lymphoma and Complete Response at 2-years With Epcoritamab Monotherapy
Year: 2025
Type: article
Abstract: Background: Depth and duration of CR correlate with long-term outcomes in LBCL. Epcor is a subcutaneous CD3xCD20 bispecific antibody approved for the treatment (tx) of pts with DLBCL or high-grade BCL after ≥2 lines of tx (LOT). In the 3-y follow-up (FU) from NHL-1 (NCT03625037), epcor led to durable CRs, with a 36-mo median CR duration (mDOCR), 37-mo median PFS (mPFS), and not reached (NR) median OS (mOS) in pts with R/R LBCL who had CR. We report long-term outcomes in pts from NHL-1 who were in CR 2y after starting tx. Methods: Pts with R/R CD20+ LBCL and ≥2 prior LOT received epcor in 28-d cycles (C; 0.16- and 0.8-mg step-up doses in C1; 48-mg full dose thereafter; QW C1–3; Q2W C4–9; Q4W C≥10) until progressive disease (PD) or unacceptable toxicity. Primary endpoint was ORR. Results: As of May 3, 2024 data cutoff (DCO), 41% (65/157) of pts had CR, of whom 49% (n=32) remained in CR at 2y. Among the 32 pts in CR at 2y, median age was 63y, 47% were male, and 66% were refractory to ≥2 consecutive prior LOT. At DCO, median FU for pts in CR at 2y was 37 mo (range 32−46). All but 1 had a response (CR or partial response) by the 2nd assessment at wk 12. mDOCR, mPFS, mOS were NR, and ~96% of pts remained in CR at 3y. At the DCO, the longest ongoing CR was >43mo. Overall epcor safety profile in pts in CR at 2y was consistent with that of the intention-to-treat population. Median tx duration was 35mo (range 8–43). 81% (26/32) of pts remained on tx at 2y. 19% (5/26) of pts still on tx at 2y had ≥1 serious infection after 2y, most commonly pneumonia (n=4). Two pts had a fatal infection (COVID-19 pneumonia, pneumonia) after 2y. At DCO, 19/32 (59%) pts with CR at 2y were still on tx. One pt discontinued (d/c) due to PD; 12 d/c for reasons other than PD, most commonly adverse events (n=6, including the 2 pts with fatal infections above). In 12 pts who d/c due to reasons other than PD, CR was maintained for a median of 14mo (range 2−28) after tx d/c. Conclusions: This subgroup analysis of pts with R/R LBCL in CR at 2y after starting epcor highlights long-term disease remission, OS, and long-term disease control with epcor in some pts with 3L+ R/R LBCL. Long-term safety remained manageable. ©2025 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2025 ASCO Annual Meeting. All rights reserved.
Authors: P.L. Zinzani, Y. H. Karimi, J.M. Vose, M. Roost Clausen, D. Cunningham, U. Farooq, T. Feldman, H. Ghesquieres, W. Jurczak, K.M. Linton, T. Phillips, W.S. Kim, P. Jafarinasabian, M. Geybels, D. Soong, B. D. Månsson, C. W. Eskelund, M. Atiya, M. Hutchings, C. Thieblemont, C.Y. Cheah
Institutions: Istituto di Ematologia di Bologna, University of Michigan, University of Nebraska Medical Center, Vejle Sygehus, Royal Marsden NHS Foundation Trust, University of Iowa, Hackensack Meridian Health, Hackensack Meridian School of Medicine, Hospices Civils de Lyon, Hôpital Lyon Sud, University of Manchester, The Christie NHS Foundation Trust, Cancer Research UK Manchester Centre, City of Hope, U-M Rogel Cancer Center, Samsung Medical Center, AbbVie (United States), University of Copenhagen, Rigshospitalet, Assistance Publique – Hôpitaux de Paris, Hôpital Saint-Louis, The University of Western Australia, Sir Charles Gairdner Hospital
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7093123745
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