AbbVie Announces Positive Phase 3 Results for Epcoritamab Plus Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

• Topline results from Phase 3 EPCORE^® DLBCL-4 trial evaluating epcoritamab in combination with lenalidomide demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL)
• EPCORE DLBCL-4 demonstrated improved PFS with a chemotherapy-free combination treatment regimen in patients with R/R DLBCL

NORTH CHICAGO, Ill., June 29, 2026 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating the combination of epcoritamab, a T-cell engaging bispecific antibody, and lenalidomide, compared to rituximab plus gemcitabine plus oxaliplatin (R-GemOx) in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who received at least one prior line of therapy. Based on topline results from the prespecified primary analysis, the trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS). The risk of disease progression and death was reduced by 60% (HR 0.40 [95% CI 0.30, 0.55]; p-value <0.0001) and 56% (HR 0.44 [95% CI 0.33, 0.60]; p-value <0.0001), based on different censoring rules in the U.S. and outside the U.S., respectively.

The safety profile of epcoritamab when administered in combination with lenalidomide was consistent with the known safety profiles of the individual agents (epcoritamab and lenalidomide).

"Despite recent advances, there remains a critical need for innovative therapies to improve outcomes for those battling DLBCL, an aggressive and often difficult-to-treat cancer," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "Today's encouraging topline results highlight the potential of epcoritamab, a fixed-treatment therapy, in combination with lenalidomide, as a meaningful treatment option after initial disease progression."

AbbVie and Genmab will engage global regulatory authorities to discuss next steps. Data will be submitted for presentation at a future medical meeting.

About the EPCORE^® DLBCL-4 Trial

EPCORE DLBCL-4 (NCT06508658) is a global Phase 3 open label, multi-center, randomized trial to evaluate the efficacy of epcoritamab (GEN3013, DuoBody^®-CD3xCD20) in combination with lenalidomide compared to chemoimmunotherapy, rituximab plus gemcitabine plus oxaliplatin (R-GemOx), in adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including patients with diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), high-grade B-Cell lymphoma (HGBL) with MYC and B-cell/lymphoma 2 (BCL2) and/or BCL6 rearrangements, follicular lymphoma grade 3B (FL3B), T-cell/histiocyte-rich large B-Cell lymphoma (TCHR LBLC), and Epstein-Barr Virus-positive diffuse large B-cell lymphoma (EBV+ DLBCL). Patients in the trial were previously treated with at least one line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy, and failed or relapsed after, or were not a candidate for autologous stem cell transplantation (ASCT) and ineligible for or unable to receive CAR-T since DLBCL diagnosis. Patients received subcutaneous epcoritamab (cycles 1–3, once weekly; cycles 4–12, once every 4 weeks) and oral lenalidomide (25 mg/day on days 1–21) for a total of twelve 28-day cycles or intravenously infused R-GemOx for up to four cycles (each cycle lasting 28 days). The trial started on August 13, 2024, and is ongoing.

More information on this trial can be found at www.clinicaltrials.gov. (NCT06508658).

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.¹

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 and territories. 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 filings for the investigational relapsed or refractory diffuse large B-cell lymphoma (DLBCL) study. 

AbbVie and Genmab 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. Please visit www.clinicaltrials.gov for more information.

USE & IMPORTANT SAFETY INFORMATION for EPKINLY^® (epcoritamab-bysp) in U.S.

What is EPKINLY?

EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory) after 2 or more treatments. EPKINLY for the treatment of DLBCL is approved based on patient response data. A study is 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 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.

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 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 include decreased white blood cells, decreased red 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 Full Prescribing Information and Medication Guide, including Important Warnings.

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, X (formerly Twitter), and YouTube.

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.

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