RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union), Priority Review (United States), Priority Review (China), Breakthrough Therapy (United States)

Structure/Sequence

Sequence Code 143818L

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Sequence Code 319323760L

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Sequence Code 319323796H

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Sequence Code 616714422H

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Clinical Trials associated with Epcoritamab

NCT07365306

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Epcoritamab-R-GemOx With Consolidative ASCT and Additional Epcoritamab in Relapsed/Refractory Transplant-Eligible DLBCL

This phase II trial tests how well epcoritamab in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) works as treatment given after the cancer has not responded to other treatments (salvage therapy) before autologous stem cell transplant in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Epcoritamab is a so-called bispecific antibody, a molecule that can bind simultaneously to two different receptors (proteins present on the cell surface). Epcoritamab binds to a receptor called CD3 with one part of the antibody and to a receptor called CD20 with another part of the antibody. CD3 is expressed on T cells, which are important cells of the immune system that help the body fight cancers and infections. CD20 is expressed on the surface of DLBCL cells. By simultaneous binding to CD3 and CD20, epcoritamab brings T cells and DLBCL cells close together and activates the T cells to kill the lymphoma cells. Rituximab is a so-called monoclonal antibody, a molecule that binds to a single receptor. Like epcoritamab, rituximab binds to CD20. After binding to CD20, rituximab activates the immune system to kill the lymphoma cell through several different mechanisms. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Giving epcoritamab-R-GemOx as therapy before an autologous stem cell transplant may help kill cancer cells in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

Start Date30 Dec 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06919939

/ RecruitingPhase 2IIT

Phase 2 Study of Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma

The purpose of this study is to determine whether combining Loncastuximab Tesirine with Epcoritamab is tolerable and effective for reducing and/or eliminating lymphoma cells in the body.

Start Date01 Feb 2026

Sponsor / Collaborator

University of Miami

[+2]

NCT07218510

/ RecruitingPhase 2IIT

A Phase 2 Study of Venetoclax + Obinutuzumab Followed by Epcoritamab in Previously Untreated Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (LonGEVity)

This phase II trial tests the effect of venetoclax and obinutuzumab followed by epcoritamab in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that have not previously received treatment. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Epcoritamab, a bispecific monoclonal antibody, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. The combination of venetoclax and obinutuzumab is a standard treatment for CLL/SLL and has been found to be safe and effective. Adding epcoritamab to standard treatment with venetoclax and obinutuzumab may lead to deeper and longer-lasting responses in patients with untreated CLL/SLL.

Start Date09 Jan 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

100 Clinical Results associated with Epcoritamab

100 Translational Medicine associated with Epcoritamab

100 Patents (Medical) associated with Epcoritamab

130

Literatures (Medical) associated with Epcoritamab

01 Feb 2026·International Journal of Laboratory Hematology

Atypical Lymphocytosis Induced by T Cell‐Engaging Therapy in Patients With Hematological Malignancies

Article

Author: Kim, Hyun Kyung ; Kim, Tae‐Shin ; Chang, Yoon Hwan ; Kim, Seon Young

ABSTRACT:

Introduction:

Atypical lymphocytes (ALYs) are activated lymphocytes with distinct morphological characteristics, often observed in various infections, autoimmune diseases, drug reactions, and malignancies. Their appearance may resemble leukemic or lymphoma cells, making it essential to differentiate ALYs, particularly in patients with hematological malignancies. With the advent of T‐cell engagers (TCEs), a novel class of immuno‐oncology drugs, this study aimed to investigate their effect on peripheral blood profiles, including ALYs.

Methods:

We retrospectively analyzed complete blood count (CBC) data and peripheral blood morphology from 28 patients enrolled in clinical trials of various TCEs targeting multiple myeloma and B‐cell lymphomas. The drugs studied included cevostamab, linvoseltamab, glofitamab, teclistamab, talquetamab, elranatamab, and epcoritamab.

Results:

A transient increase in ALYs was observed in 11 of the 28 patients treated with TCEs. This was confirmed by changes in cell morphology and flow cytometric parameters obtained from the CBC analyzer. ALY elevation appeared to be influenced by drug type, administration route, and combination therapies. In addition, a sudden and transient decrease in both monocytes and lymphocytes was noted in peripheral blood following cevostamab treatment.

Conclusion:

The observed increase in ALYs likely reflects immune activation induced by TCEs. Understanding ALY dynamics during TCE treatment is crucial for clinicians and pathologists when interpreting patient test results. Furthermore, ALY testing may serve as a potential marker for predicting the effectiveness of TCE therapies.

01 Jan 2026·Lancet Haematology

Epcoritamab monotherapy for Richter transformation (EPCORE CLL-1): findings from a single-arm, multicentre, open-label, phase 1b/2 trial

Article

Author: Poulsen, Christian Bjørn ; Eichhorst, Barbara ; Shadman, Mazyar ; Oki, Toshihiko ; Kater, Arnon P ; Steele, Andrew J ; Christensen, Jacob Haaber ; Holst Mørch, Marie ; Janssens, Ann ; Guan, Meijian ; Rios, Marcia ; Eradat, Herbert ; Sandoval-Sus, Jose D ; Thompson, Meghan C ; Offner, Fritz ; Bellido, Mar ; Valentin, Rebecca

BACKGROUND:

Richter transformation is one of the most challenging B-cell lymphomas to treat, particularly in patients with high-risk chronic lymphocytic leukaemia features or who have had previous therapy for chronic lymphocytic leukaemia. Median survival remains 6-12 months across various therapeutic approaches. We evaluated the safety and preliminary activity of epcoritamab monotherapy, a subcutaneous CD3×CD20 bispecific antibody, in patients with Richter transformation.

METHODS:

This multicentre, open-label, phase 1b/2 trial was conducted at 24 centres in nine countries (Australia, Belgium, Denmark, Germany, Israel, Italy, Spain, The Netherlands, and USA). Eligible patients were aged 18 years or older and had histologically confirmed Richter transformation (diffuse large B-cell lymphoma [DLBCL]), an Eastern Cooperative Oncology Group performance status of 0-2, and up to two previous lines of Richter transformation-directed therapy. The trial includes dose-escalation and dose-expansion phases. The expansion groups evaluate epcoritamab monotherapy (group 2A), epcoritamab plus lenalidomide (group 2B), and epcoritamab plus the combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; group 2C). The current report describes results from group 2A. Epcoritamab was administered subcutaneously in step-up doses followed by 48 mg every week for cycles 1-3, every 2 weeks for cycles 4-9, and every 4 weeks thereafter until disease progression or unacceptable toxicity. The primary endpoint was investigator-assessed overall response rate per Lugano 2014 criteria in the full analysis set (all patients who received ≥1 dose of epcoritamab). It was evaluated against a null hypothesis of 30% versus an alternative of 50%. Prespecified subgroup analyses by line of therapy for Richter transformation and TP53 aberration and/or del(17p) status were performed. Safety was assessed in all treated patients. This trial is ongoing and registered with ClinicalTrials.gov, NCT04623541.

FINDINGS:

Between Oct 18, 2021, and March 21, 2025, we enrolled 42 patients with Richter transformation. The median age was 69 years (range 50-80); and 32 (76%) of 42 patients were male and ten (24%) were female. Race or ethnicity data were available for 40 patients (37 [88%] identified as White, two [5%] as Asian, and one [2%] as Black or African American; ethnicity was not reported for two patients). The median time from diagnosis of chronic lymphocytic leukaemia or small lymphocytic lymphoma to Richter transformation was 7·6 years (range 0-23·9). 21 (50%) of 42 patients received epcoritamab as first-line Richter transformation-directed therapy. At a median follow-up of 22·9 months (range 0·5-39·9), 20 of 42 patients had a response with an investigator-assessed overall response rate of 47·6% (95% CI 32·0-63·6), which did not meet the prespecified alternative hypothesis (50%). Overall response occurred in 12 of 21 patients in the first-line population (overall response rate 57·1%, 34·0-78·2), in eight of 21 patients in the second-line or later-line population (38·1%, 18·1-61·6), and in eight of 20 patients with TP53 aberration and/or del(17p) alteration at baseline (40%, 19·1-63·9). The most common grade 3-4 adverse events were neutropenia in 19 (45%) of 42 patients, anaemia in 16 (38%) patients, thrombocytopenia in 16 (38%) patients, infection in nine (21%) patients, pneumonia in four (10%) patients, and COVID-19 in two (5%) patients. Cytokine release syndrome occurred in 36 (86%) patients with three (7%) being grade 3, immune effector cell-associated neurotoxicity syndrome in five (12%; all grade 1-2) patients and clinical tumour lysis syndrome in two (5%; all grade 1-2) patients. Three fatal adverse events were reported, one each due to general physical health deterioration in the context of progressive disease, sepsis, and cerebrovascular accident; none were considered by the investigator to be related to study treatment.

INTERPRETATION:

In patients with Richter transformation, epcoritamab monotherapy showed clinically meaningful antitumour activity, although the investigator-assessed overall response rate was below the alternative hypothesis of 50%, with a safety profile consistent with previous studies. These findings support further investigation of epcoritamab as a potential treatment option for patients with Richter transformation.

FUNDING:

Genmab A/S and AbbVie.

01 Jan 2026·LANCET

Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial

Article

BACKGROUND:

An unmet need persists for chemotherapy-free regimens that induce durable responses for relapsed or refractory follicular lymphoma. Lenalidomide and rituximab (R²) is an accepted standard of care in this population. The EPCORE FL-1 trial aimed to evaluate the efficacy and safety of epcoritamab plus R² versus R² in participants with relapsed or refractory follicular lymphoma after at least one previous line of chemoimmunotherapy.

METHODS:

In this multicountry, open-label, phase 3 trial, participants were randomly allocated (1:1) to fixed-duration epcoritamab plus R² or R² for up to 12 cycles. Epcoritamab was administered weekly in cycles 1-3 and every 4 weeks in cycles 4-12, lenalidomide once daily during cycles 1-12 (days 1-21), and rituximab weekly during cycle 1 and monthly in cycles 2-5. The dual primary endpoints were overall response rate and progression-free survival by independent review committee. The data reported here are from a planned interim analysis carried out after 78% of progression-free survival events had occurred. This study is registered with ClinicalTrials.gov, NCT05409066, and EudraCT, 2021-000169-34, and is ongoing (closed to recruitment).

FINDINGS:

Out of 668 participants screened for eligibility across 189 academic and non-academic centres in 30 countries across Africa, Asia, Australia, Europe, North America, and South America, a total of 488 participants were randomly allocated, 243 to epcoritamab plus R² and 245 to R². The trial met its dual primary endpoints, showing superiority of epcoritamab plus R² over R² in overall response rate and progression-free survival. With a median follow-up of 14·8 months (IQR 11·4-19·0), overall response rate was 95% (95% CI 92-97) with epcoritamab plus R² versus 79% (74-84; p<0·0001) with R². Progression-free survival was longer with epcoritamab plus R² versus R² (hazard ratio 0·21 [95% CI 0·14-0·31], p<0·0001); estimated 16-month progression-free survival favoured epcoritamab plus R² (85·5% vs 40·2%). Grade 3 or higher adverse events were more frequent with epcoritamab plus R² (219 [90%] of 243 participants) versus R² (161 [68%] of 238 participants). Cytokine release syndrome was low grade with epcoritamab plus R² (grade 1 in 28 [21%] participants and grade 2 in seven [5%] participants) and manageable, and all events were resolved.

INTERPRETATION:

Epcoritamab plus R² resulted in significantly higher response rate and longer progression-free survival versus R² among participants with follicular lymphoma who had received at least one line of therapy. Epcoritamab plus R² had more grade 3 or higher adverse events versus R². Adverse events were manageable and consistent with the established safety profiles of the individual components, with no new safety findings identified. These findings position epcoritamab plus R² as a new standard of care for second-line or subsequent treatment of follicular lymphoma.

FUNDING:

AbbVie and Genmab.

229

News (Medical) associated with Epcoritamab

22 Jan 2026

·news.abbvie.com

AbbVie Announces Topline Results for Epcoritamab (DuoBody® CD3xCD20) from Phase 3 EPCORE® DLBCL-1 Trial in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Based on the topline results from the EPCORE® DLBCL-1 trial, AbbVie along with partner Genmab will engage global regulatory authorities to discuss next steps Jan. 16, 2026 -- AbbVie (NYSE: ABBV) today announced topline results from the Phase 3 EPCORE® DLBCL-1 trial evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, compared to investigator's choice of chemoimmunotherapy in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The study demonstrated an improvement in progression-free survival (PFS) (HR: 0.74 [95% CI 0.60 to 0.92])*. Improvements were observed in complete response rates (CRR), duration of response (DoR), and time to next treatment among patients treated with epcoritamab. The study did not demonstrate a statistically significant improvement in overall survival (OS) (HR: 0.96 [95% CI 0.77 to 1.20]). EPCORE DLBCL-1 is the first Phase 3 study to demonstrate improvement in PFS in patients with R/R DLBCL who were treated with a CD3xCD20 T-cell engaging bispecific monotherapy. The global study enrolled 483 patients with R/R DLBCL with at least one prior line of therapy (73% had received two or more prior lines) who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The adverse events observed in this study appear consistent with known safety of epcoritamab. AbbVie and Genmab are working to assess the potential impact of various factors, including the COVID-19 pandemic (trial conducted at the peak of the Omicron variant and prior to the widespread availability of vaccines) and the increased availability of novel anti-lymphoma therapies during the study timeline. The data will be submitted for presentation at a future medical meeting, and AbbVie and Genmab will engage global regulatory authorities to determine next steps. DLBCL is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30% of all NHL cases.1,2 In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year.3 DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.4,5 DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, management can still be challenging.4,6 Epcoritamab (EPKINLY® in the U.S. and Japan and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in more than 65 countries. AbbVie and Genmab remain committed to advancing epcoritamab, with ongoing clinical programs evaluating the therapy as a monotherapy and in combination regimens across treatment lines and a broad range of hematologic malignancies. EPCORE DLBCL-1 (NCT04628494) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy, either rituximab plus gemcitabine plus oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR), in patients with relapsed or refractory DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The trial started on January 13, 2021, and is ongoing. 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.7 Epcoritamab (approved under the brand name EPKINLY® in countries including the U.S. and Japan, and TEPKINLY® in the European Union) has received regulatory approval in certain lymphoma indications in more than 65 countries. Epcoritamab is being co-developed by AbbVie and Genmab 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 DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. The safety and efficacy of epcoritamab has not been established for these investigational uses. AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. 1Lymphoma Research Foundation. Diffuse Large B-Cell Lymphoma. Accessed December 2025. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/dlbcl/ 2Padala, et al. Diffuse Large B-Cell Lymphoma. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. 2023 Apr 24. 3Leukemia and Lymphoma Society. Diffuse Large B-Cell Lymphoma (DLBCL). Accessed November 2024. https://www.lls.org/research/diffuse-large-b-cell-lymphoma-dlbcl 4Sehn, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384:842-858. doi: 10.1056/NEJMra2027612. 5Kanas, et al. Epidemiology of Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) in the United States and Western Europe: Population-Level Projections for 2020-2025. Leuk Lymphoma. 2022;63(1):54-63. doi: 10.1080/10428194.2021.1975188. 6Crump, et al. Outcomes in Refractory Diffuse Large B-Cell Lymphoma: Results From the International SCHOLAR-1 Study. Blood. 2017;130(16):1800-1808. doi: 10.1182/blood-2017-03-769620. 7Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625. The content above comes from the network. if any infringement, please contact us to modify.

$AbbVie Announces Topline Results for Epcoritamab (DuoBody® CD3xCD20) from Phase 3 EPCORE® DLBCL-1 Trial in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)$

Clinical ResultDrug ApprovalImmunotherapyCell Therapy

19 Jan 2026

·www.biospace.com

Genmab Announces Topline Results for Epcoritamab (DuoBody® CD3xCD20) from Phase 3 EPCORE® DLBCL-1 Trial in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Company Announcement Based on the topline results from the EPCORE ® DLBCL-1 trial, Genmab will engage global regulatory authorities to discuss next steps COPENHAGEN, Denmark; January 16, 2026 – Genmab A/S (Nasdaq: GMAB) today announced topline results from the Phase 3 EPCORE DLBCL-1 trial evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, which demonstrated an improvement in progression-free survival (PFS) (HR: 0.74 [95% CI 0.60 to 0.92]) * in patients treated with epcoritamab monotherapy. Additionally, improvements were observed in the complete response rate, duration of response, and time to next treatment among patients treated with epcoritamab monotherapy. EPCORE DLBCL-1 is the first Phase 3 study to demonstrate an improvement in PFS in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who were treated with a CD3xCD20 T-cell engaging bispecific monotherapy. The study demonstrated an overall survival (OS) of HR: 0.96 [95% CI 0.77 to 1.20], which did not reach statistical significance. The global study enrolled 483 patients with R/R DLBCL with at least one prior line of therapy (73% had received two or more prior lines) who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The study evaluated the safety and efficacy of epcoritamab monotherapy compared to investigator’s choice of either rituximab plus gemcitabine and oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR). The adverse events observed in this study appear consistent with the known safety pro epcoritamab. Further analysis of the results is ongoing, including the potential impact of various factors, such as the COVID-19 pandemic and increasing availability of novel anti-lymphoma therapies. The full trial results will be submitted for presentation at a future medical meeting. Genmab and AbbVie will engage with global regulatory authorities to discuss next steps. Data is anticipated in 2026 from two Phase 3 trials evaluating fixed duration epcoritamab in patients with DLBCL, including EPCORE DLBCL-2, a front-line study evaluating epcoritamab in combination with standard-of-care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP), and EPCORE DLBCL-4, evaluating epcoritamab in combination with lenalidomide versus chemo-immunotherapy in patients with relapsed or refractory DLBCL. “The EPCORE DLBCL-1 trial is the first Phase 3 study evaluating a bispecific antibody monotherapy to demonstrate improvements in progression-free survival in patients with relapsed or refractory DLBCL,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “The results from this global trial contribute to the growing body of evidence supporting epcoritamab and build upon the robust foundation established by epcoritamab, which has been used to treat thousands of patients in need of additional therapeutic options. Together with our partner, AbbVie, we remain deeply committed to advancing the development of epcoritamab as a potential core therapy across a broad range of B-cell malignancies.” Epcoritamab (approved under the brand name EPKINLY ® in countries including the U.S. and Japan, and as TEPKINLY ® in the European Union) has received regulatory approval in certain lymphoma indications in more than 65 countries. Genmab and AbbVie remain committed to advancing the potential of epcoritamab, with ongoing clinical programs evaluating the therapy as a monotherapy and in combination regimens across treatment lines and a broad range of hematologic malignancies. *Based on intent-to-treat principle. About Diffuse Large B-Cell Lymphoma Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases. i , ii In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year. iii DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men. iv , v DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge. iv , vi About the EPCORE DLBCL-1 Trial EPCORE DLBCL-1 ( NCT04628494 ) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, DuoBody ® -CD3xCD20) compared to investigator's choice of chemotherapy, either rituximab plus gemcitabine plus and oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR), in patients with relapsed or refractory DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The trial started on January 13, 2021, and is ongoing. More information on this trial can be found at . 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. vii 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. Where approved, epcoritamab is a readily accessible therapy. 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 three ongoing Phase 3, open-label, randomized trials, among them a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL ( NCT05578976 ), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL ( NCT06508658 ), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R 2 ) compared to chemoimmunotherapy in patients with previously untreated FL ( NCT06191744 ). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit for more information. About Genmab Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X . Contact: Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs T: +1 609 524 0065; E: mmp@genmab.com Andrew Carlsen, Vice President, Head of Investor Relations T: +45 3377 9558; E: acn@genmab.com This Company Announcement contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at . Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab ® ; the Y-shaped Genmab logo ® ; Genmab in combination with the Y-shaped Genmab logo ® ; HuMax ® ; DuoBody ® ; HexaBody ® ; DuoHexaBody ® , HexElect ® and KYSO™. EPCORE ® , EPKINLY ® , TEPKINLY ® and their designs are trademarks of AbbVie Biotechnology Ltd. i Lymphoma Research Foundation. Diffuse Large B-Cell Lymphoma. Accessed December 2025. ii Padala, et al. Diffuse Large B-Cell Lymphoma. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. 2023 Apr 24. iii Leukemia and Lymphoma Society. Diffuse Large B-Cell Lymphoma (DLBCL). Accessed November 2024. iv Sehn, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med . 2021;384:842-858. doi: 10.1056/NEJMra2027612. v Kanas, et al. Epidemiology of Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) in the United States and Western Europe: Population-Level Projections for 2020-2025. Leuk Lymphoma . 2022;63(1):54-63. doi: 10.1080/10428194.2021.1975188. vi Crump, et al. Outcomes in Refractory Diffuse Large B-Cell Lymphoma: Results From the International SCHOLAR-1 Study. Blood . 2017;130(16):1800-1808. doi: 10.1182/blood-2017-03-769620. vii Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625. Company Announcement no. 01 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Genmab A/S Carl Jacobsens Vej 30 2500 Valby Denmark Attachment 011626_CA01_EPCORE DLBCL-1 TOPLINE

Phase 3ImmunotherapyClinical ResultDrug Approval

19 Jan 2026

·www.biospace.com

AbbVie, Genmab’s Bispecific Misses Key Overall Survival Endpoint in Phase III Lymphoma Study

iStock, Wel_nofri Despite the late-stage miss, analysts maintained confidence in the Epkinly program, with Truist Securities saying the result “doesn’t waver our optimism” regarding the bispecific antibody’s ongoing frontline trial. AbbVie and Genmab’s bispecific antibody Epkinly did not significantly improve overall survival in a late-stage study of patients with a specific type of relapsed or refractory diffuse large B cell lymphoma. Analysts appeared to find these results discouraging but maintained faith in the Epkinly franchise. In a note to investors on Friday, William Blair called the outcome “unfortunate” but added that it “doesn’t detract from key second/first-line DLBCL readouts in 2026.” Similarly, while Truist Securities found the overall survival (OS) miss “disappointing,” the analysts said in a Friday note that it “doesn’t waver our optimism on [Epkinly’s] frontline trial.” The Phase III EPCORE DLBCL-1 trial, which is still ongoing, has enrolled 483 patients with relapsed or refractory disease who can’t undergo high-dose chemotherapy or autologous stem cell transplantation. Results announced on Friday showed a 4% improvement in OS in patients treated with Epkinly versus those given an investigator’s choice of chemotherapy. This effect did not reach statistical significance. The FDA is considering OS as a primary endpoint for EPCORE DLBCL-1, William Bair explained on Friday. The analysts added that failing to elicit a significant benefit here has raised questions/concerns from investors as to whether the current relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) indication, approved under the accelerated pathway in May 2023 , is at risk. As an accelerated nod, Epkinly’s continued approval in this indication depends on the verification of its clinical benefit in a Phase III confirmatory study. Despite the miss, “we believe it is unlikely Epkinly would lose accelerated approval in DLBCL,” the analysts added. Beyond OS, Epkinly did show a significant improvement in progression-free survival, cutting the risk of disease progression or death by 26% compared to chemotherapy. The bispecific also led to improvements in other endpoints, including complete response rate, duration of response and time to next treatment. With these findings, AbbVie and Genmab said they will approach global health authorities to determine the best path forward for Epkinly in this indication. The two companies originally partnered in June 2020 to collaborate on the development of Epkinly and today share commercialization responsibilities in the U.S. In DLBCL, the companies are also running the Phase III EPCORE-DLBCL-4 study, which is assessing Epkinly in combination with lenalidomide against chemo-immunotherapy, according to Friday’s release . There is also the late-stage EPCORE DLBCL-2, combining Epkinly with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone. Both studies are set to read out this year.

Phase 3ImmunotherapyAccelerated ApprovalPhase 2Clinical Result

100 Deals associated with Epcoritamab

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Large B-cell lymphoma	Canada	AbbVie, Inc.	13 Oct 2023
Recurrent Grade 3b Follicular Lymphoma	Canada	AbbVie, Inc.	13 Oct 2023
Mediastinal large B-cell lymphoma	Japan	Genmab A/S	25 Sep 2023
Recurrent Follicular Lymphoma	Japan	Genmab A/S	25 Sep 2023
Refractory Follicular Lymphoma	Japan	Genmab A/S	25 Sep 2023
Diffuse large B-cell lymphoma recurrent	European Union	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma recurrent	Iceland	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma recurrent	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma recurrent	Norway	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma refractory	European Union	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma refractory	Iceland	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma refractory	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma refractory	Norway	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse Large B-Cell Lymphoma	United States	Genmab, Inc.	19 May 2023
High grade B-cell lymphoma	United States	Genmab, Inc.	19 May 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory Grade 3a Follicular Lymphoma	Phase 3	United States	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	China	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Japan	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Australia	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Belgium	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Brazil	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Bulgaria	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Canada	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Croatia	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Czechia	Genmab A/S	05 Feb 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04628494 (EPCORE DLBCL-1, Company_Website) Manual	Phase 3	Diffuse large B-cell lymphoma refractory \| Diffuse large B-cell lymphoma recurrent	483	Epcoritamab	rmfmgyhgwh(jjbzdamssm): HR = 0.74 (95.0% CI, 0.6 - 0.92) View more	Negative	16 Jan 2026
				rituximab + gemcitabine + oxaliplatin (R-GemOx) or bendamustine + rituximab (BR)
NCT04623541 (EPCORE CLL-1, Pubmed \| Lancet Haematol)	Phase 1/2	Richter's syndrome	42	Epcoritamab	wybnhmbmse(gazrorsjjj) = 5% patients skttjdmlld (jjvypmgozd ) View more	Positive	01 Jan 2026
				Epcoritamab (TP53 aberration and/or del(17p) alteration)
NCT05409066 (EPCORE FL-1, Pubmed \| Lancet)	Phase 3	Refractory Follicular Lymphoma Second line	488	Epcoritamab + Lenalidomide + Rituximab	laizqqrtxu(azummumhmc) = ssmyicptmv rofgitixwm (zxpryqpcxz, 92 - 97) View more	Superior	01 Jan 2026
				Lenalidomide + Rituximab	laizqqrtxu(azummumhmc) = fzfzulmlxz rofgitixwm (zxpryqpcxz, 74 - 84) View more
NCT05409066 (EPCORE FL-1, BusinessWire) Manual	Phase 3	Follicular Lymphoma Second line	488	EPKINLY+rituximab+lenalidomide	vmokfroukj(gfwipsqxdb) = eptmgznftk zgnghcyuwd (wpnuzrdqha, 91.5 - 97.4) View more	Positive	07 Dec 2025
				rituximab+lenalidomide	vmokfroukj(gfwipsqxdb) = tssqsqpbot zgnghcyuwd (wpnuzrdqha, 73.6 - 84.1) View more
NCT05451810 (EPCORE™ NHL6, ASH2025)	Phase 2	Diffuse Large B-Cell Lymphoma Third line	92	Epcoritamab	dikymwxsdg(qksrfslubz) = eyahvoqpgt tjbdatonfa (isxgnvhkuu, 32.1 - 53.1) View more	Positive	06 Dec 2025
NCT04623541 (EPCORE CLL-1, ASH2025)	Phase 1/2	Richter's syndrome First line	42	Epcoritamab 48 mg (1L RT-directed therapy)	iuezugvlix(zmdxkorngk) = vglosuofra trrzfcxlcl (yqymawuzlv, 34 - 78) View more	Positive	06 Dec 2025
				Epcoritamab 48 mg (second- or later-line (2L+) settings)	iuezugvlix(zmdxkorngk) = knnojbjvsz trrzfcxlcl (yqymawuzlv, 18 - 62) View more
NCT03625037 (EPCORE NHL-1, ASH2025)	Phase 2	Third line	157	Epcoritamab	bjagqffpby(trcjefjcfl) = oxdhzaixuz ysyqdiacxu (axnkofwckp ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	-	31	Epcoritamab	jmncbdqtuu(xbkxhknywx) = oknvusncsr mkwsuuyenz (mvejrogzic )	Positive	06 Dec 2025
				Glofitamab	jmncbdqtuu(xbkxhknywx) = liiayyfyow mkwsuuyenz (mvejrogzic ) View more
ASH2025	Not Applicable	Lymphoma	12	Epcoritamab	drejphaorb(gbfgznjoqs) = dtixajyipb qakvtaayom (dectbepemn )	Positive	06 Dec 2025
ASH2025	Not Applicable	Large B-cell lymphoma	17	Epcoritamab or Glofitamab	yoamuttthh(jpjlakkalz) = 1 patient had grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS). owmfscvyqi (tajwjkikca ) View more	Positive	06 Dec 2025
				Epcoritamab or Glofitamab

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