Genmab to Highlight New Data Evaluating Late-Stage Oncology Portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

22.05.25 23:05 Uhr

Media Release

COPENHAGEN, Denmark; May 22, 2025

  • First presentation of results from Phase 1/2 clinical trial of investigational rinatabart sesutecan (Rina-S®) in patients with recurrent/advanced endometrial cancer
  • Presentation of long-term follow-up data from analysis of Phase 1/2 EPCORE™ NHL-1 study of epcoritamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL)
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Genmab A/S (Nasdaq: GMAB) announced today that it will present new research from its comprehensive development program evaluating its late-stage portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 to June 3 in Chicago, Illinois.

The presentations will include the first disclosure of results from a Phase 1/2 trial evaluating rinatabart sesutecan (Rina-S®), an investigational folate receptor-alpha (FRa)-targeted, TOPO1-inhibor antibody-drug conjugate (ADC), in patients with recurrent/advanced endometrial cancer. Additionally, results from an analysis of the Phase 1/2 EPCORE NHL-1 study of epcoritamab, a T-cell–engaging bispecific antibody administered subcutaneously, including long-term follow-up in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who remain in complete response (CR) at 2 years, will be presented.

"Our presence at ASCO reflects our commitment to advancing our antibody science for patients in need of alternative treatment options, including women with endometrial cancers that have progressed following treatment with existing available therapies,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "We’re particularly encouraged by Rina-S as a potential treatment option for endometrial cancer, one of the few cancers with rising mortality rates and few treatment options. Additionally, together with AbbVie, we are continuing our commitment to evaluating epcoritamab as a potential core therapy across B-cell malignancies.”

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Investor Update at ASCO 2025
On Monday, June 2 at 4:00 PM CDT (5:00 PM EDT/11:00 PM CEST), Genmab will host a review of the Rina-S data presented at ASCO. The event will be virtual and webcast live. Details, including the webcast link and registration, will be available on https://ir.genmab.com/events-presentations. This meeting is not an official program of the ASCO Annual Meeting.

All abstracts accepted for presentation have been published and may be accessed online via the ASCO Meeting Library. Abstracts accepted for presentation at ASCO include:

Rinatabart sesutecan (Rina-S)

Abstract NumberAbstract TitleType of PresentationDate/Time of Presentation
3039Winer et al. Rinatabart sesutecan (Rina-S) for patients with advanced endometrial cancer: First disclosure from dose expansion cohort B2 of the GCT1184-01 study.PosterJune 2; 1:30 p.m.-4:30 p.m. CDT

TPS5627
Secord et al. A phase 3, open-label, randomized study of rinatabart sesutecan (Rina-S) vs investigator’s (IC) of chemotherapy in patients with platinum-resistant ovarian cancerPosterJune 1, 9:00 a.m.-12:00 p.m. CDT
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Epcoritamab

Abstract
Number
Abstract TitleType of PresentationDate/Time of Presentation
7043Karimi et al. Novel analysis of 3-y results from the pivotal EPCORE NHL-1 study: Outcomes in patients with relapsed/refractory large B-cell lymphoma and complete response at 2 y with epcoritamab monotherapyPosterJune 1; 9:00 a.m.-12:00 p.m. CDT
e19001Zhao et al. First data from phase 1b/2 EPCORE NHL-4: epcoritamab (epcor) in Chinese patients (Pts) with relapsed or refractory diffuse large B-cell lymphomaPublicationNA

Non-Asset

Abstract
Number
Abstract TitleType of PresentationDate/Time of Presentation
6046Maghsoudi et al. Fusion of Radiomic, Pathomic, and Clinical Biomarkers Reveals Multi-scale Tumor Biology, Improves OS
Stratification in HNSCC receiving Standard of Care (SOC)
PosterJune 2; 9:00 a.m.-12:00 p.m. CDT

The safety and efficacy of investigational products and uses have not been established.

About Rinatabart Sesutecan (Rina-S; GEN1184)
Rinatabart sesutecan (Rina-S; GEN1184) is a FRa-targeted, TOPO1 ADC, currently being evaluated for the potential treatment of ovarian cancer and other FRa-expressing cancers. A Phase 3 trial (RAINFOLTM-02, NCT06619236) evaluating Rina-S in patients with platinum resistant ovarian cancer compared to treatment of investigator's choice is ongoing. In January 2024, the U.S. Food and Drug Administration granted Fast Track designation to Rina-S for the treatment of patients with FRa-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.

The safety and efficacy of rinatabart sesutecan has not been established. Please visit www.clinicaltrials.gov for more information.

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 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 chemoimmunotherapy 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.

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 more than 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.

Contact:        
David Freundel, Senior Director, Product Communications
T: +1 609 613 0504; E: dafr@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 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, 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. i10
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark


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