- More than 20 abstracts, including seven oral presentations, highlight advancements from the epcoritamab development program supporting the expanded clinical profile and potential of epcoritamab for a broader range of B-cell malignancies
- New data demonstrate potential of epcoritamab in first and second-line settings in follicular lymphoma (FL) and first-line in diffuse large B-cell lymphoma (DLBCL)
- Results from Phase 3 EPCORE FL-1 trial, evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with relapsed or refractory (R/R) follicular lymphoma (FL) accepted for oral presentation
Genmab A/S (Nasdaq: GMAB) today announced that more than 20 abstracts evaluating epcoritamab-bysp, a T-cell engaging bispecific antibody administered subcutaneously, across lines of therapy and B-cell non-Hodgkin's lymphoma (NHL) subtypes, will be presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH), in Orlando, Florida, and online, December 6-9.
Data from the epcoritamab development program will showcase its expanding clinical profile and potential utility in earlier lines of therapy with a fixed treatment duration. Presentations include three oral sessions supporting the potential of epcoritamab in the first- and second-line setting in patients with follicular lymphoma (FL) and two oral presentations evaluating epcoritamab in the first-line setting in patients with diffuse large B-cell lymphoma (DLBCL). Additionally, two oral presentations will summarize the efficacy and safety of epcoritamab as monotherapy and in combination for patients with Richter transformation (RT).
"The breadth and depth of data evaluating epcoritamab at this year's American Society of Hematology meeting spotlight the growing body of clinical evidence supporting the potential of epcoritamab and underscore our commitment to developing epcoritamab as a potential core therapy across a range of B-cell malignancies," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "We look forward to sharing our data at ASH, including the full pivotal results from the Phase 3 EPCORE FL-1 trial evaluating epcoritamab in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma."
2025 R&D Update and ASH Data Review
On Thursday, December 11 at 11:00 a.m. ET/5:00 p.m. CEST, Genmab will host its 2025 R&D Update and ASH Data Review. The event will be virtual and webcast live. Details, including the webcast link and registration will be available on www.genmab.com. This meeting is not an official program of the ASH Annual Meeting.
All abstracts accepted for presentation have been published and may be accessed on the ASH website. The following abstracts evaluating epcoritamab have been accepted for presentation at ASH:
Oral Presentations
Abstract Number | Abstract Title | Type of Presentation | Date/Time of Presentation |
63 | Vitolo et al., Fixed-duration epcoritamab monotherapy induces high response and MRD-negativity rates in elderly patients with newly diagnosed large B-cell lymphoma (LBCL) and comorbidities: results from EPCORE DLBCL-3 | Oral | December 6, 9:30 11:00 AM
|
64 | Cheah et al., Epcoritamab R-mini-CHOP results in 2-year remissions and high MRD negativity rates in elderly patients with newly diagnosed DLBCL: results from the EPCORE NHL-2 trial | Oral | December 6, 9:30 11:00 AM
|
464* | Merryman et al., Rituximab and epcoritamab as first-line therapy for patients with high-tumor burden follicular lymphoma: Results of a multicenter phase II trial | Oral | December 7, 9:30-11:00 AM
|
465 | Leslie et al., Epcoritamab with rituximab lenalidomide (R2) and epcoritamab maintenance deliver deep and durable remissions in previously untreated (1L) follicular lymphoma (FL): 3-year outcomes from EPCORE NHL-2 arms 6 and 7 | Oral | December 7, 9:30 11:00 AM
|
466 | Falchi et al., Primary phase 3 results from the EPCORE FL-1 trial of epcoritamab with rituximab and lenalidomide (R2) versus R2 for relapsed or refractory follicular lymphoma | Oral | December 7, 9:30 AM 11:00 AM
|
1015 | Thompson et al., Epcoritamab combinations demonstrate promising efficacy in patients (pts) with Richter transformation (RT): first results from arms 2B (epcor lenalidomide [LEN]) and 2C (epcor R-CHOP) of the phase 1b/2 EPCORE CLL-1 trial | Oral | December 8, 4:30 6:00 PM
|
1017 | Kater et al., Epcoritamab monotherapy demonstrates promising efficacy in patients with Richter transformation (RT): 2-year follow-up results from arm 2A of the phase 1b/2 EPCORE CLL-1 trial | Oral | December 8, 4:30 6:00 PM
|
*Investigator-led trial | |||
Poster Presentations
Abstract Number | Abstract Title | Type of Presentation | Date/Time of Presentation |
1820 | Noorani et al., Optimal dose of epcoritamab in combination with lenalidomide and rituximab in relapsed or refractory follicular lymphoma analysis of pharmacokinetics and exposure-response relationships of EPCORE FL-1 phase 3 study | Poster | December 6, 5:30 7:30 PM |
1955 | Falchi et al., Fixed-duration epcoritamab R-CHOP in patients with newly diagnosed DLBCL and high IPI scores (3-5) led to sustained remissions and disease-free survival beyond 3-years: results from the EPCORE NHL-2 trial | Poster | December 6, 5:30 7:30 PM |
1959 | Torres Lopez et al., Outpatient administration of epcoritamab monotherapy for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL): results from the EPCORE NHL-6 by race and ethnicity | Poster | December 6, 5:30- 7:30 PM |
1960 | Thieblemont et al., Epcoritamab (epcore) monotherapy offers long-term disease control in large B-cell lymphoma (LBCL): NHL-1 subgroup analysis in patients with prior chimeric antigen receptor T-cell (CAR T) therapy from the 3-year follow-up | Poster | December 6, 5:30 7:30 PM |
2721 | Park et al., Barriers to receiving CAR T-cell treatment among patients with non-Hodgkin lymphoma who were deemed eligible for CAR T-cell therapy | Poster | December 6, 5:30 7:30 PM |
3565 | Robinson et al., Phenotype and functional state of endogenous T-cells support T-cell engager therapy in the post-CAR T setting | Poster | December 7, 6:00 8:00 PM |
3566 | Takacs et al., Exposure to epcoritamab is associated with improved T-cell functionality and dynamic changes in CD8+ T-cells in diffuse large B-cell lymphoma: insights from EPCORE NHL-6 | Poster | December 7, 6:00 8:00 PM |
3736 | Brody et al., Epcoritamab GemOx achieves durable >2-year remissions in relapsed/refractory (R/R) 2L+ diffuse large B-cell lymphoma (DLBCL): long-term data reinforce clinical potential of the regimen across a diverse patient population | Poster | December 7, 6:00 -8:30 PM |
4481 | Xavier et al., Underreporting of prognostic factors in real-world studies for bispecifics in relapsed or refractory diffuse large B-cell lymphoma | Poster | December 7, 6:00 8:00 PM |
5511 | Cheah et al., Durable responses in patients with large B-cell lymphoma and 3+ prior lines of therapy who either paused or discontinued epcoritamab monotherapy while in complete response | Poster | December 8, 6:00 8:00 PM |
5513 | Karimi et al., Sustained remissions beyond 4 years with epcoritamab monotherapy: long-term follow-up results from the pivotal EPCORE NHL-1 trial in patients with relapsed or refractory large B-cell lymphoma | Poster | December 8, 6:00 8:00 PM |
5357 | Vitolo et al., Fixed-duration epcoritamab in combination with bendamustine rituximab (BR) for first-line (1L) treatment of follicular lymphoma (FL): 3-year results from EPCORE NHL-2 arm 3 demonstrate deep and durable responses with manageable safety | Poster | December 8, 6:00 8:00 PM |
5370 | Linton et al., HRQoL in relapsed/refractory follicular lymphoma patients treated with epcoritamab in combination with rituximab plus lenalidomide (E+R2): primary results of patient-reported outcomes from the EPCORE FL-1 trial | Poster | December 8, 6:00 8:00 PM |
5393 | Strati et al., EPCORE FL-2 phase 3 trial of epcoritamab with rituximab and lanalidomide (R2) vs chemoimmunotherapy (CIT) in previously untreated follicular lymphoma (FL): trial in progress | Poster | December 8, 6:00 8:00 PM |
e-Publications
Abstract Number | Abstract Title | Type of Presentation | Date/Time of Presentation |
7251 | Johnson et al., Epcoritamab monotherapy provides superior efficacy vs non-anthracycline-containing regimens in newly diagnosed elderly DLBCL patients deemed unsuitable for anthracycline-containing regimens: a match-adjusted comparative efficacy analysis | Publication | NA |
7942 | Graff et al., Operational efficiencies and cost savings of using one bispecific antibody FDA-approved for both R/R 3L+ DLBCL and FL | Publication | NA |
8075 | Ali et al., Effectiveness of epcoritamab in a heterogeneous population with relapsed/refractory diffuse large B-cell lymphoma including post-chimeric antigen receptor T-cell therapy patients: insights from the real-world epcoritamab patient characteristics and outcomes research (Real-EPCOR) study | Publication | NA |
The safety and efficacy of epcoritamab have not been established for these investigational uses.
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.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 several territories. 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 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 has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.
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 Genmab
Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines.
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.
This 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 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 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.
________________________________ i 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. |
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