On November 3, 2025 Genmab A/S (Nasdaq: GMAB) reported that more than 20 abstracts evaluating epcoritamab-bysp, a T-cell engaging bispecific antibody administered subcutaneously, across lines of therapy and B-cell non-Hodgkin’s lymphoma (NHL) subtypes, will be presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper), in Orlando, Florida, and online, December 6-9.
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Data from the epcoritamab development program will showcase its expanding clinical profile and potential utility in earlier lines of therapy with a fixed treatment duration. Presentations include three oral sessions supporting the potential of epcoritamab in the first- and second-line setting in patients with follicular lymphoma (FL) and two oral presentations evaluating epcoritamab in the first-line setting in patients with diffuse large B-cell lymphoma (DLBCL). Additionally, two oral presentations will summarize the efficacy and safety of epcoritamab as monotherapy and in combination for patients with Richter transformation (RT).
"The breadth and depth of data evaluating epcoritamab at this year’s American Society of Hematology (ASH) (Free ASH Whitepaper) meeting spotlight the growing body of clinical evidence supporting the potential of epcoritamab and underscore our commitment to developing epcoritamab as a potential core therapy across a range of B-cell malignancies," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "We look forward to sharing our data at ASH (Free ASH Whitepaper), including the full pivotal results from the Phase 3 EPCORE FL-1 trial evaluating epcoritamab in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma."
2025 R&D Update and ASH (Free ASH Whitepaper) Data Review
On Thursday, December 11 at 11:00 a.m. ET/5:00 p.m. CEST, Genmab will host its 2025 R&D Update and ASH (Free ASH Whitepaper) Data Review. The event will be virtual and webcast live. Details, including the webcast link and registration will be available on www.genmab.com. This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.
All abstracts accepted for presentation have been published and may be accessed on the ASH (Free ASH Whitepaper) website. The following abstracts evaluating epcoritamab have been accepted for presentation at ASH (Free ASH Whitepaper):
Oral Presentations
Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
63 Vitolo et al., 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 Oral December 6, 9:30 – 11:00 AM (Presentation: 10:00 AM – 10:15 AM)
64 Cheah et al., Epcoritamab + R-mini-CHOP results in 2-year remissions and high MRD negativity rates in elderly patients with newly diagnosed DLBCL: results from the EPCORE NHL-2 trial Oral December 6, 9:30 – 11:00 AM (Presentation: 10:15 – 10:30 AM)
464* Merryman et al., Rituximab and epcoritamab as first-line therapy for patients with high-tumor burden follicular lymphoma: Results of a multicenter phase II trial Oral December 7, 9:30-11:00 AM
(Presentation: 9:45 – 10:00 AM)
465 Leslie et al., Epcoritamab with rituximab + lenalidomide (R2) and epcoritamab maintenance deliver deep and durable remissions in previously untreated (1L) follicular lymphoma (FL): 3-year outcomes from EPCORE NHL-2 arms 6 and 7 Oral December 7, 9:30 – 11:00 AM (Presentation: 10:00 – 10:15 AM)
466 Falchi et al., 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 Oral December 7, 9:30 AM – 11:00 AM (Presentation: 10:15 – 10:30 AM)
1015 Thompson et al., Epcoritamab combinations demonstrate promising efficacy in patients (pts) with Richter transformation (RT): first results from arms 2B (epcor + lenalidomide [LEN]) and 2C (epcor + R-CHOP) of the phase 1b/2 EPCORE CLL-1 trial Oral December 8, 4:30 – 6:00 PM (Presentation: 4:30 – 4:45 PM)
1017 Kater et al., Epcoritamab monotherapy demonstrates promising efficacy in patients with Richter transformation (RT): 2-year follow-up results from arm 2A of the phase 1b/2 EPCORE CLL-1 trial Oral December 8, 4:30 – 6:00 PM (Presentation: 5:00 – 5:15 PM)
*Investigator-led trial
Poster Presentations
Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
1820 Noorani et al., Optimal dose of epcoritamab in combination with lenalidomide and rituximab in relapsed or refractory follicular lymphoma – analysis of pharmacokinetics and exposure-response relationships of EPCORE FL-1 phase 3 study Poster December 6, 5:30 – 7:30 PM
1955 Falchi et al., Fixed-duration epcoritamab + R-CHOP in patients with newly diagnosed DLBCL and high IPI scores (3-5) led to sustained remissions and disease-free survival beyond 3-years: results from the EPCORE NHL-2 trial Poster December 6, 5:30 – 7:30 PM
1959 Torres Lopez et al., Outpatient administration of epcoritamab monotherapy for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL): results from the EPCORE NHL-6 by race and ethnicity Poster December 6, 5:30- 7:30 PM
1960 Thieblemont et al., Epcoritamab (epcore) monotherapy offers long-term disease control in large B-cell lymphoma (LBCL): NHL-1 subgroup analysis in patients with prior chimeric antigen receptor T-cell (CAR T) therapy from the 3-year follow-up Poster December 6, 5:30 – 7:30 PM
2721 Park et al., Barriers to receiving CAR T-cell treatment among patients with non-Hodgkin lymphoma who were deemed eligible for CAR T-cell therapy Poster December 6, 5:30 – 7:30 PM
3565 Robinson et al., Phenotype and functional state of endogenous T-cells support T-cell engager therapy in the post-CAR T setting Poster December 7, 6:00 – 8:00 PM
3566 Takacs et al., Exposure to epcoritamab is associated with improved T-cell functionality and dynamic changes in CD8+ T-cells in diffuse large B-cell lymphoma: insights from EPCORE NHL-6 Poster December 7, 6:00 – 8:00 PM
3736 Brody et al., Epcoritamab + GemOx achieves durable >2-year remissions in relapsed/refractory (R/R) 2L+ diffuse large B-cell lymphoma (DLBCL): long-term data reinforce clinical potential of the regimen across a diverse patient population Poster December 7, 6:00 -8:30 PM
4481 Xavier et al., Underreporting of prognostic factors in real-world studies for bispecifics in relapsed or refractory diffuse large B-cell lymphoma Poster December 7, 6:00 – 8:00 PM
5511 Cheah et al., Durable responses in patients with large B-cell lymphoma and 3+ prior lines of therapy who either paused or discontinued epcoritamab monotherapy while in complete response Poster December 8, 6:00 – 8:00 PM
5513 Karimi et al., Sustained remissions beyond 4 years with epcoritamab monotherapy: long-term follow-up results from the pivotal EPCORE NHL-1 trial in patients with relapsed or refractory large B-cell lymphoma Poster December 8, 6:00 – 8:00 PM
5357 Vitolo et al., Fixed-duration epcoritamab in combination with bendamustine + rituximab (BR) for first-line (1L) treatment of follicular lymphoma (FL): 3-year results from EPCORE NHL-2 arm 3 demonstrate deep and durable responses with manageable safety Poster December 8, 6:00 – 8:00 PM
5370 Linton et al., HRQoL in relapsed/refractory follicular lymphoma patients treated with epcoritamab in combination with rituximab plus lenalidomide (E+R2): primary results of patient-reported outcomes from the EPCORE FL-1 trial Poster December 8, 6:00 – 8:00 PM
5393 Strati et al., EPCORE FL-2 phase 3 trial of epcoritamab with rituximab and lanalidomide (R2) vs chemoimmunotherapy (CIT) in previously untreated follicular lymphoma (FL): trial in progress Poster December 8, 6:00 – 8:00 PM
e-Publications
Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
7251 Johnson et al., Epcoritamab monotherapy provides superior efficacy vs non-anthracycline-containing regimens in newly diagnosed elderly DLBCL patients deemed unsuitable for anthracycline-containing regimens: a match-adjusted comparative efficacy analysis Publication NA
7942 Graff et al., Operational efficiencies and cost savings of using one bispecific antibody FDA-approved for both R/R 3L+ DLBCL and FL Publication NA
8075 Ali et al., Effectiveness of epcoritamab in a heterogeneous population with relapsed/refractory diffuse large B-cell lymphoma including post-chimeric antigen receptor T-cell therapy patients: insights from the real-world epcoritamab patient characteristics and outcomes research (Real-EPCOR) study Publication NA
The safety and efficacy of epcoritamab have not been established for these investigational uses.
About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i
Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.
Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.
(Press release, Genmab, NOV 3, 2025, View Source [SID1234659256])