Genmab Announces TEPKINLY® (epcoritamab) in Combination with Lenalidomide and Rituximab is Approved by the European Commission for the Treatment of Relapsed or Refractory Follicular Lymphoma
Media Release
COPENHAGEN, Denmark; July 6, 2026
- TEPKINLY® (epcoritamab) plus lenalidomide and rituximab (R2) is the first and only bispecific-based therapy approved in Europe for the treatment of follicular lymphoma in the second-line setting, offering a chemotherapy-free option
- In the Phase 3 EPCORE® FL-1 trial, fixed-duration TEPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to R2, with approximately three out of four patients achieving a complete response
Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) granted marketing authorization for TEPKINLY® (epcoritamab) in combination with lenalidomide and rituximab (TEPKINLY + R2)for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE® FL-1 trial that evaluated fixed-duration TEPKINLY + R2 compared to standard of care R2.
“Follicular lymphoma is a persistent form of cancer that remains incurable, which means patients need more treatment options. Patients often relapse and experience shorter remissions and have fewer treatment options each time the disease returns,” said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris Cité University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. “The results shown in the EPCORE FL-1 trial are clinically meaningful, demonstrating the potential for TEPKINLY + R2 to change the treatment paradigm for patients, offering the chance at a durable response with a chemotherapy-free option.”
The marketing authorization is supported by data from the Phase 3 EPCORE FL-1 trial, an open-label interventional trial to evaluate the safety and efficacy of TEPKINLY + R2 compared to R2 alone in patients with R/R FL. The study demonstrated TEPKINLY + R2 reduced the risk of disease progression or death by 79% (HR 0.21, 95% CI: 0.13 - 0.33, p<0.0001) compared to R2 alone. The overall response rate (ORR) in patients treated with TEPKINLY + R2 was 96% (95% CI: 90.2, 98.6) compared to 81% in patients treated with R2 (95% CI: 72.7, 87.7; p<.0001). Among patients who were treated with TEPKINLY + R2, 74% achieved a complete response (CR) (n=181/243, 95% CI: 68.5, 79.8) compared to a 43% CR rate among patients treated with R2 (n=106/245, 95% CI: 37.0, 49.7).
The safety profile of TEPKINLY + R2 in the EPCORE FL-1 study was consistent with the known safety profiles of the individual regimens (epcoritamab and R2). In the trial, the most common (≥ 20%) adverse reactions were neutropenia, rash, upper respiratory tract infections, fatigue, diarrhea, injection site reactions, anemia, constipation, thrombocytopenia, cytokine release syndrome (CRS), hypogammaglobulinemia, COVID-19, pyrexia, and pneumonia. Serious adverse reactions occurred in 44% of patients who received epcoritamab in combination with lenalidomide and rituximab. Serious adverse reactions in ≥ 5% of patients included CRS, pneumonia, COVID-19, and febrile neutropenia.
"The marketing authorization of TEPKINLY + R2by the European Commission represents a pivotal moment for individuals living with follicular lymphoma, providing a treatment option at first relapse, when effective intervention is critical,” said Judith Klimovsky, M.D., Executive Vice President & Chief Development Officer of Genmab. “This milestone reinforces TEPKINLY 's potential as a core therapy across B-cell malignancies, validating its use in combination and earlier follicular lymphoma settings, while building upon its established efficacy as a monotherapy in advanced disease. "
FL is typically a slow-growing form of non-Hodgkin lymphoma (NHL) that arises from B-cell lymphocytes. FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases.i FL incidence is significantly higher in European populations, 11-29 percent, compared to non-European populations, 2-18 percent.ii FL is considered incurable, and there is no standard of care treatment for third-line or later FL.i,iii Patients who achieve remission also often experience relapse.iv,v, vi
"A diagnosis of follicular lymphoma can bring a relentless cycle of disease recurrence and treatment,” said Mitchell Smith, M.D., Ph.D., Chief Medical Officer of the Follicular Lymphoma Foundation. “The approval of epcoritamab now in combination with R2in Europe is a welcome advance that will bring an innovative treatment option and hope to the follicular lymphoma community.”
About the EPCORE FL-1 Trial
EPCORE® FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus lenalidomide and rituximab (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The Phase 3 EPCORE FL-1 study included patients with relapsed or recurrent FL following at least one prior line of treatment across a broad range of patient characteristics and disease risk factors. Patients were randomized to receive epcoritamab in combination with R2 (n=243) or R2alone (n=245). Patients received epcoritamab in 28-day cycles for a total of 12 cycles or until disease progression or unacceptable toxicity, whichever occurred first. Efficacy was established based on the dual primary endpoints of progression free survival (PFS) and overall response rate (ORR) determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC). Additional efficacy outcome measures include complete response (CR) and duration of response (DOR). The pivotal Phase 3 EPCORE FL-1 trial results were published in The Lancet in January 2026.
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.vi
Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the European Union) has received regulatory approval in certain lymphoma indications in more than 65 territories. 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 relapsed or refractory (R/R) follicular lymphoma (FL) indication and additional approvals for the R/R diffuse large B-cell lymphoma (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 several Phase 3, open-label, randomized trials, including a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.
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 and X.
Contact:
Caitlin Craparo, Vice President, Global Communications & Corporate Affairs
T: +1 609 255 7397; E: cacr@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
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 onwww.genmab.com and 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.
i Lymphoma Research Foundation official website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed May 2026.
ii Zhau Y, et al. Anthropometric indicators may explain the high incidence of follicular lymphoma in Europeans: Results from a bidirectional two-sample two-step Mendelian randomization. Volume 911, 15 June 2024, 148320. https://doi.org/10.1016/j.gene.2024.148320.
iii Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023;108(3):822-832. doi: 10.3324/haematol.2022.281421
ivLymphoma Research Foundation official website. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/follicular-lymphoma/relapsedfl/. Accessed May 2026.
v Rivas‐Delgado, A, Magnano, L, Moreno‐Velázquez, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708
vi 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.
Media Release no. 09
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark
Attachment
© 2026 GlobeNewswire, Inc. All Rights Reserved.
