Genmab与AbbVie澄清EPCORE DLBCL-1在美国唯一主要终点OS未达标

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)
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July 23, 2026
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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) and
AbbVie (NYSE: ABBV)
today provided clarification on the primary endpoints from the
Phase 3 EPCORE
DLBCL-1 study
evaluating 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.
Genmab
and
AbbVie
previously 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 Epcoritamab
Epcoritamab 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 names 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 indications and safety information.
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
https://www.clinicaltrials.gov/
.
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.
ii,iii
In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year.
iv
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.
v,vi
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,vii
EPKINLY
(epcoritamab-bysp) U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION
What is EPKINLY?
EPKINLY is a prescription medicine used to treat adults with:
certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory) after 2 or more treatments.
follicular lymphoma (FL) that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab
follicular lymphoma (FL) that has come back or that did not respond after 2 or more treatments.
EPKINLY for the treatment of DLBCL is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY.
It is not known if EPKINLY is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Important Warnings—EPKINLY can cause serious side effects, including:
Cytokine release syndrome (CRS)
, which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule.
Neurologic problems
that can be serious, and can be life-threatening, and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.
People with DLBCL or high-grade B-cell lymphoma
may be hospitalized after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems.
People with FL
may be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS and neurologic problems.
Tell your healthcare provider or get medical help right away
if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss.
These may be symptoms of CRS or neurologic problems.
If you have any symptoms that impair consciousness,
do not
drive or use heavy machinery or do other dangerous activities until your symptoms go away.
EPKINLY can cause other serious side effects, including:
Infections
that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion.
Low blood cell counts,
which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems.
Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.
Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you
have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby.
If you are a female who can become pregnant
, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.
The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include
CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain.
The most common severe abnormal laboratory test results with EPKINLY when used alone
include decreased white blood cells, decreased red blood cells, and decreased platelets.
The most common side effects of EPKINLY when used together with lenalidomide and rituximab in FL include
rash
upper respiratory tract infections, tiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever.
The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab
include decreased white blood cells and decreased platelets.
These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects.
You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).
Please see
Medication Guide
, including Important Warnings.
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
X
About AbbVie in Oncology
AbbVie 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 at
http://www.abbvie.com/oncology
About AbbVie
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 including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at
www.abbvie.com
. Follow @abbvie on
LinkedIn,
Facebook
Instagram
YouTube.
Genmab Contacts:
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
AbbVie Contacts:
Raquel Powers, Director, Oncology Public Affairs
T: +1 847 935 6563; E:
raquel.powers@abbvie.com
Todd Bosse, Vice President, Investor Relations
T: +1 847-936-1182; E:
todd.bosse@abbvie.com
Genmab Forward-Looking Statements
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
www.genmab.com
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
www.sec.gov
. 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.
AbbVie Forward-Looking Statements
Some 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.
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.
ii
Lymphoma Research Foundation. Diffuse Large B-Cell Lymphoma. Accessed February 2026.
https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/dlbcl/
iii
Padala, et al. Diffuse Large B-Cell Lymphoma. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. 2023 Apr 24.
Leukemia and Lymphoma Society. Diffuse Large B-Cell Lymphoma (DLBCL). Accessed February 2026.
https://www.lls.org/research/diffuse-large-b-cell-lymphoma-dlbcl
v
Sehn, et al. Diffuse Large B-Cell Lymphoma.
N Engl J Med
. 2021;384:842-858. doi: 10.1056/NEJMra2027612.
vi
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.
vii
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.
The information in the press releases on these pages was factually accurate on the date of publication. These press releases remain on AbbVie's website for historical purposes only. AbbVie assumes no duty to update the information to reflect subsequent developments. Readers should not rely upon the information in these pages as current or accurate after their publication dates.
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