Dp015 | Epcoritamab + R-ice in Patients With Relapsed/refractory Diffuse Large B-cell Lymphoma Eligible for Autologous Stem Cell Transplantation: Epcore Nhl-2
Year: 2025
Type: article
Abstract: Introduction: Pts with LBCL are often refractory to salvage chemoimmunotherapy (CIT). An unmet need remains to optimize salvage therapy (tx), allowing more pts to go to ASCT. We present results from the NHL-2 trial (NCT04663347) of epcor, a subcutaneous CD3xCD20 bispecific antibody, plus R-ICE in pts with R/R DLBCL eligible for ASCT. Methods: Pts had R/R DLBCL, were eligible for R-ICE and ASCT, and had ≥1 prior line of tx (LOT). Pts received epcor (0.16- and 0.8-mg step-up doses in cycle [C]1 and 48 mg thereafter; QW C1–4; Q2W C5–9; Q4W C10+) and R-ICE (C1−3). C1−4 were 21 d and C5+ were 28 d. Tx was given until ASCT, progressive disease (PD), or unacceptable toxicity. Primary endpoint was investigator-assessed overall response rate (ORR; Lugano criteria). Results: As of Dec 18, 2024, 31 pts received epcor+R-ICE. Median follow-up was 11 mo (range, 6−15). Median age was 62 y, 55% were male, 61% were Ann Arbor stage III/IV, 81% had 1 prior LOT, and 65% had progressed within 12 mo of 1L tx. ORR was 87%; 65% of pts had a CR and 23% had PR. High ORRs and CR rates were seen in subgroups of interest. Of 31 pts, 20 (65%) received ASCT. Before ASCT, 13/20 pts were in CR and 7/20 in PR. 5/7 pts with PR achieved CR after ASCT. Of the 11 pts who did not proceed to ASCT, 3 (10%) remained on epcor (1 in CR and 2 in PR) and 8 (26%) discontinued tx due to PD (n=6) or other reasons (n=2). Of those, 6 proceeded to a subsequent tx. At 6 mo, ~81% of responses were ongoing, 74% of pts were progression free, and 100% of pts were alive. Most common TEAEs were neutropenia (74%), anemia (68%), and thrombocytopenia (68%). CRS (grade 1/2) occurred in 52%; all resolved. One pt had grade 1 ICANS, which resolved. Infections occurred in 18 (58%) pts; 5 (16%) had serious infections. There were no CTLS, grade 5 TEAEs, or epcor discontinuations due to TEAEs. Conclusions: Epcor+R-ICE demonstrated high CR rates in pts with R/R DLBCL eligible for ASCT, most of whom were high risk, having progressed <12 mo of 1L tx. Safety was manageable, with no discontinuations due to AEs. These results demonstrate that epcor, when combined with CIT, may optimize salvage tx, increasing the proportion of pts proceeding to ASCT compared with historical rates, providing a greater chance of a cure. ©2025 European Hematology Association. Reused with permission. This abstract was accepted at the 2025 EHA Annual Meeting.
Authors: G. Musuraca, S. De Vos, D. Morillo, R. Cordoba, P. Gomez Prieto, J. Darrah, E. Hawkes, R. Mous, A. Sureda, R.W. Merryman, T. Jiang, J. Marek, L. Wang, M. Risum, C. Thieblemont, P. Abrisqueta, M. Trneny, U. Vitolo
Institutions: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, University of California, Los Angeles, Ronald Reagan UCLA Medical Center, Los Angeles Medical Center, Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario La Paz, Cedars-Sinai Medical Center, Olivia Newton-John Cancer Wellness & Research Centre, Austin Health, University Medical Center Utrecht, Institut d'Investigació Biomédica de Bellvitge, Institut Català d'Oncologia, Dana-Farber Cancer Institute, AbbVie (United States), Assistance Publique – Hôpitaux de Paris, Hôpital Saint-Louis, Vall d'Hebron Hospital Universitari, Charles University, Candiolo Cancer Institute
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7093123193
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