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Genmab and AbbVie Provide Clarification on Phase 3 EPCORE® DLBCL-1 Trial Evaluating Epcoritamab (DuoBody®-CD3xCD20) in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Key Takeaway: Genmab and AbbVie clarified that the Phase 3 EPCORE DLBCL-1 trial did not meet its primary endpoint of overall survival for the treatment of relapsed/refractory diffuse large B-cell lymphoma. The trial compared epcoritamab to standard chemoimmunotherapy but showed no significant improvement in patient outcomes. Additional results will be submitted for publication in a peer-reviewed journal.

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CONCERNS & RISKS

  • The primary endpoint of overall survival was not met in the trial.
  • The study did not demonstrate a statistically significant improvement in OS.
  • The lack of improvement in OS raises concerns about the efficacy of epcoritamab.

Full Press Release Details

Media Release

COPENHAGEN, Denmark and NORTH CHICAGO, Ill.; July 23, 2026

• Genmab and AbbVie clarify overall survival (OS) was the sole U.S. primary endpoint in the Phase 3 EPCORE®DLBCL-1 trial and was not met
Genmab A/S(Nasdaq: GMAB)andAbbVie (NYSE: ABBV)todayprovidedclarificationonthe primary endpoints from thePhase 3 EPCORE®DLBCL-1 studyevaluating monotherapy epcoritamab (DuoBody®-CD3xCD20),a T-cell engaging bispecific antibody administered subcutaneously, compared with investigator's choice of chemoimmunotherapy (CIT) of either rituximab plus gemcitabine plus oxaliplatin (R-GemOx) or bendamustine plus rituximab (BR) in adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who were ineligible for autologous stem cell transplantation.GenmabandAbbViepreviously announced topline results of the study on January 16, 2026, and additional study results were subsequently presented at the European Hematology Association (EHA) 2026 Congress on June 12, 2026.
EPCORE DLBCL-1 is a global, Phase 3, open label, multi-center, randomized clinical trial with prespecified primary endpoints that differ by region. In the United States, where overall survival (OS) is the sole primary endpoint, the study did not demonstrate a statistically significant improvement in OS and therefore did not meet its primary endpoint.
Additional results of the EPCORE DLBCL-1 study will be submitted for publication in a peer-reviewed medical journal.
About EpcoritamabEpcoritamab is approved under the FDA's accelerated approval pathway for the treatment of adult patients with R/R DLBCL, not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after two or more lines of systemic 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. Genmab and AbbVie continue to evaluate 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. Data from EPCORE DLBCL-2, evaluating fixed duration epcoritamab in combination with standard-of-care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP), in patients with newly diagnosed DLBCL are anticipated in 2026. This follows the recent disclosure of topline results from the Phase 3 EPCORE DLBCL-4 study, evaluating fixed-duration epcoritamab in a chemotherapy-free combination with lenalidomide in patients with R/R DLBCL.
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 more than 65 territories. Where approved, epcoritamab is a readily accessible therapy.
Please see local country prescribing information for all labeled indication and safety information.
About the EPCORE DLBCL-1 TrialEPCORE 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.
More information on this trial can be found athttps://www.clinicaltrials.gov/.
About Diffuse Large B-Cell LymphomaDiffuse 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.ii,iiiIn the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year.ivDLBCL 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.v,viDLBCL 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,vii
About GenmabGenmab 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 visitGenmab.comand follow us onLinkedInandX.About AbbVie in OncologyAbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.
Today, our expansive oncology portfolio is comprised of approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 35 investigational medicines across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit us athttp://www.abbvie.com/oncology.
About AbbVieAbbVie'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 including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
Genmab Contacts:Marisol Peron, Senior Vice President, Global Communications & Corporate AffairsT: +1 609 524 0065; E:mmp@genmab.com AbbVie Contacts:Raquel Powers, Director, Oncology Public AffairsT: +1 847 935 6563; E:raquel.powers@abbvie.com
Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E:acn@genmab.com Todd Bosse, Vice President, Investor RelationsT: +1 847-936-1182; E:todd.bosse@abbvie.com
Genmab Forward-Looking StatementsThis Media Release 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 onwww.genmab.comand the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filingswith the U.S. Securities and Exchange Commission (SEC), which are available atwww.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release 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.
AbbVie Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
iEngelberts 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.iiLymphoma Research Foundation. Diffuse Large B-Cell Lymphoma. Accessed February 2026.https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/dlbcl/iiiPadala, et al. Diffuse Large B-Cell Lymphoma. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. 2023 Apr 24.ivLeukemia and Lymphoma Society. Diffuse Large B-Cell Lymphoma (DLBCL). Accessed February 2026.https://www.lls.org/research/diffuse-large-b-cell-lymphoma-dlbclvSehn, et al. Diffuse Large B-Cell Lymphoma.N Engl J Med. 2021;384:842-858. doi: 10.1056/NEJMra2027612.viKanas, 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.viiCrump, 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.
Media Release no. i10CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122
Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark

Attachment

• 230726_MRi10_EPCORE DLBCL-1 Clarification

Frequently Asked Questions

What was the primary endpoint of the EPCORE DLBCL-1 trial?

The primary endpoint was overall survival (OS), which was not met.

What treatment was evaluated in the EPCORE DLBCL-1 trial?

The trial evaluated epcoritamab compared to standard chemoimmunotherapy.

When were the topline results of the study announced?

The topline results were announced on January 16, 2026.

What is epcoritamab used for?

Epcoritamab is used for treating adult patients with relapsed/refractory DLBCL.

Last updated: Jul 23, 2026