Epcoritamab

Oncology R&D News Data presented at 13th Society of Hematologic Oncology (SOHO) Annual Meeting NORTH CHICAGO, Ill., Sept. 3, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced updated results from the Phase 2 EPCORE® NHL-6 trial (NCT05451810) evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of epcoritamab monotherapy, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy. Results from the study demonstrated that the incidence and severity of cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) following treatment with epcoritamab were consistent with previous epcoritamab studies in R/R DLBCL. These results were shared today during a poster presentation (Abstract #ABCL-1224) at the 13th Society of Hematologic Oncology (SOHO) Annual Meeting. In the study, 88 patients received the first full dose (48 mg) of epcoritamab monotherapy. Of these, 81 patients (92%) were monitored in the outpatient setting and seven (8%) in the inpatient setting. Overall, CRS events occurred in 37 (40.2%) of patients during the entire trial period (n=92), were primarily low grade (Grade 1-2), all resolved with a median time of two days, and no events led to treatment discontinuation. ICANS occurred in seven patients (7.6%), were primarily low grade (Grade 1-2), all resolved with a median time of three days, and no events led to treatment discontinuation. "The EPCORE® NHL-6 trial results are notable, as current bispecific antibody treatments for relapsed and refractory diffuse large B-cell lymphoma patients may require in-hospital monitoring for cytokine release syndrome after certain initial doses and as needed after subsequent doses," said Jeff Sharman, M.D., disease chair, hematology research, Sarah Cannon Research Institute (SCRI) at Willamette Valley Cancer Institute in Eugene, Oregon. "The possibility of treating patients in the outpatient setting is encouraging, and it may enable more people to have access to this treatment option across various sites of care, including community settings." The study also showed an overall response rate (ORR) of 64.3% and a complete response (CR) rate of 47.6%, at a median follow-up of 5.8 months, in patients (n=42) treated with epcoritamab after only one prior line of systemic therapy. In patients treated with epcoritamab following two or more lines of systemic therapy (n=50), with a median follow-up of 10.8 months, the study showed an ORR of 60.0% and a CR rate of 38.0%. Currently, epcoritamab is approved for R/R DLBCL after two or more prior lines of systemic therapy and is being investigated for use in earlier lines of therapy. See approved indication and important safety information below. "The updated EPCORE® NHL-6 trial findings presented at the Society of Hematologic Oncology Annual Meeting suggest that treatment of relapsed/refractory diffuse large B-cell lymphoma with epcoritamab can be safe in the outpatient setting. This potential shift to outpatient care could help improve access to treatment," said Svetlana Kobina, M.D., Ph.D, vice president, oncology medical affairs, AbbVie. "AbbVie remains committed to building on our leadership in blood cancer, which includes advancing research with our partner Genmab, that firmly establishes the impact of investigational epcoritamab in successive lines of treatment across B-cell malignancies." DLBCL is the most common type of non-Hodgkin's 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 The use of epcoritamab in an outpatient setting for the first full dose in R/R DLBCL and as monotherapy in DLBCL in the second-line setting has not been approved by the U.S. FDA or any other Health Authority. About the EPCORE® NHL-6 Trial EPCORE® NHL-6 is a Phase 2 open-label clinical trial evaluating the safety of outpatient administration of subcutaneous epcoritamab as monotherapy in adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The primary objective of the trial was to assess adverse events within three months of treatment initiation with epcoritamab monotherapy. The primary outcome measures were the percentage of participants experiencing Grade 3 or higher cytokine release syndrome (CRS) events, immune cell-associated neurotoxicity syndrome (ICANS) events, and/or neurotoxicity (Ntox) events. Secondary outcomes included responses to treatment as determined by Lugano 2014 criteria and assessed by investigators. EPCORE® NHL-6 enrolled 92 patients with R/R DLBCL who had received at least one prior line of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy. At the time of data cutoff (January 15, 2025), 92 patients had received ≥1 dose of epcoritamab (community: n=41; academic: n=51). Median follow-up was 7.6 months (range, 6.0-9.2) and 50% remained on treatment. Median age was 69 years, 83% had Ann Arbor stage III-IV, 24% had prior CAR T, 24% had bulky disease ≥7cm, and 51% had International Prognostic Index (IPI) ≥3. More information can be found at https://www.clinicaltrials.gov/ (NCT05451810). 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.7 Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies 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 have not been established for these investigational uses. EPKINLY® (epcoritamab-bysp) U.S. INDICATIONS & 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), high-grade B-cell lymphoma, or follicular lymphoma (FL) that has come back or that did not respond to previous treatment after receiving 2 or more treatments. EPKINLY 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 life-threatening. 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 should be hospitalized for 24 hours 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, or feeling weak or generally unwell. 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), 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. In DLBCL or high-grade B-cell lymphoma, the most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets. In follicular lymphoma the most common side effects of EPKINLY include injection site reactions, CRS, COVID-19, tiredness, upper respiratory tract infections, muscle and bone pain, rash, diarrhea, fever, cough, and headache. The most common severe abnormal laboratory test results include decreased white blood cells and decreased red blood cells. 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. Globally, prescribing information varies; refer to the individual country product label for complete information. 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 comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials 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 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, oncology, neuroscience and eye care – 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. 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, and changes to laws and regulations applicable to our industry. 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 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. 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. Contacts: Media: Anisha Bagchi Manix Email: anisha.manix@abbvie.com Investors: Todd Bosse Email: todd.bosse@abbvie.com _______________________________________ 1 Lymphoma Research Foundation. Diffuse Large B-Cell Lymphoma. Accessed November 2024. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/dlbcl/ 2 Padala, et al. Diffuse Large B-Cell Lymphoma. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. 2023 Apr 24. 3 Leukemia and Lymphoma Society. Diffuse Large B-Cell Lymphoma (DLBCL). Accessed November 2024. https://www.lls.org/research/diffuse-large-b-cell-lymphoma-dlbcl 4 Sehn, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384:842-858. doi: 10.1056/NEJMra2027612. 5 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. 6 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. 7 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. US-EPCOR-250039 SOURCE AbbVie

AbbVie and Genmab’s epcoritamab has shown promise as part of a combination treatment for relapsed or refractory follicular lymphoma (FL). The phase 3 EPCORE FL-1 trial has been comparing subcutaneous epcoritamab plus rituximab and lenalidomide (R2) against R2 alone in adult patients. The study achieved its dual primary endpoints of overall response rate and progression-free survival, lowering the risk of disease progression or death by 79%. The safety profile of the combination was also found to be consistent with the known safety profiles of the individual regimens. Approximately 15,000 people develop FL, a slow growing form of non-Hodgkin lymphoma, every year in the US. The disease is considered incurable, with patients frequently relapsing and the prognosis worsening after each subsequent relapse. Epcoritamab, which already holds approvals in certain lymphoma indications under the brand names Epkinly and Tepkinly, is an IgG1-bispecific antibody designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induce T-cell-mediated killing of CD20-positive cells. The US Food and Drug Administration (FDA) recently granted priority review to the drug in combination with R2 following at least one prior systemic therapy, setting a target review date of 30 November this year. If approved, epcoritamab in combination R2 would be the first bispecific antibody combination regimen available in the US as a second-line treatment option for patients with relapsed or refractory FL. Genmab’s chief executive officer, Jan van de Winkel, said: “While therapeutic options exist for patients with relapsed or refractory FL, response rates tend to decline and durability diminishes with each subsequent line of treatment, which can increase the risk of the disease transforming into aggressive large-cell lymphoma. “The results from this trial, and the decision from the FDA to accept the supplemental Biologics License Application for priority review, demonstrate the potential of this epcoritamab combination therapy to reshape the treatment landscape…” The announcement comes just over a year after the FDA granted accelerated approval to epcoritamab as a single agent for adults with relapsed or refractory FL who have received at least two lines of prior therapy. Both AbbVie and Genmab share commercial responsibilities for epcoritamab in the US and Japan, while AbbVie is responsible for further global commercialisation.