Genmab (GMAB) Phase 3 epcoritamab combo cuts DLBCL progression risk

Q: What did Genmab (GMAB) announce in its June 2026 6-K filing?

Genmab announced positive topline Phase 3 results from the EPCORE DLBCL-4 trial. Epcoritamab plus lenalidomide significantly improved progression-free survival versus R-GemOx in adults with relapsed or refractory diffuse large B-cell lymphoma after at least one prior systemic therapy.

Q: How effective was epcoritamab plus lenalidomide in Genmab’s EPCORE DLBCL-4 trial?

The combination significantly reduced the risk of disease progression or death. Hazard ratios were 0.40 in the U.S. and 0.44 outside the U.S., corresponding to 60% and 56% risk reductions, both with highly significant p values below 0.0001.

Q: What was the control treatment in Genmab’s EPCORE DLBCL-4 study?

The control arm received standard-of-care R-GemOx, a chemoimmunotherapy regimen comprising rituximab, gemcitabine and oxaliplatin. Epcoritamab plus lenalidomide, given as a fixed-duration, chemotherapy-free regimen, was directly compared against this standard in adult relapsed or refractory large B-cell lymphoma.

Q: Did Genmab report any new safety concerns for epcoritamab in this trial?

The topline update stated that the safety profile of epcoritamab combined with lenalidomide was consistent with the previously reported safety profiles of each drug. No additional specific safety signals or detailed adverse event rates were provided in this announcement.

Q: What are Genmab and AbbVie planning to do with the EPCORE DLBCL-4 data?

Genmab and AbbVie plan to engage with global regulatory authorities based on the positive Phase 3 results. They also intend to submit detailed EPCORE DLBCL-4 data for presentation at a future medical meeting, supporting potential expansion of epcoritamab’s indications in B-cell malignancies.

Q: What type of patients were enrolled in Genmab’s EPCORE DLBCL-4 trial?

The trial enrolled adults with relapsed or refractory large B-cell lymphoma, including DLBCL and related subtypes. Patients had received at least one prior systemic anti-CD20-containing regimen and were ineligible for, had failed, or relapsed after autologous stem cell transplant and were ineligible for CAR-T therapy.

Filing Impact

(Neutral)

Filing Sentiment

(Neutral)

Form Type

6-K

Rhea-AI Filing Summary

Genmab reported positive topline Phase 3 results from the EPCORE DLBCL-4 trial of epcoritamab plus lenalidomide in adults with relapsed or refractory diffuse large B-cell lymphoma. The combination, given as a fixed-duration, chemotherapy-free regimen, was compared with standard R-GemOx chemoimmunotherapy.

The study met its primary objective, showing a statistically significant and clinically meaningful improvement in progression-free survival. Depending on regional censoring rules, the risk of disease progression or death was reduced by 60% (HR 0.40; 95% CI 0.30–0.55) in the U.S. and 56% (HR 0.44; 95% CI 0.33–0.60) outside the U.S., both with p<0.0001.

The safety profile of epcoritamab plus lenalidomide was consistent with previously known profiles of each drug. Genmab and its partner AbbVie plan to engage global regulators and present detailed data at a future medical meeting, supporting epcoritamab’s potential broader role across B-cell malignancies.

Positive

Strong Phase 3 efficacy signal: EPCORE DLBCL-4 met its primary endpoint, with epcoritamab plus lenalidomide reducing the risk of progression or death by up to 60% versus R-GemOx, providing a robust, statistically significant efficacy readout in relapsed/refractory DLBCL.

Negative

None.

Insights

Phase 3 success strongly supports epcoritamab’s role in relapsed DLBCL.

The EPCORE DLBCL-4 trial in relapsed/refractory large B-cell lymphoma achieved its primary endpoint, with epcoritamab plus lenalidomide significantly prolonging progression-free survival versus R-GemOx. Hazard ratios of 0.40 and 0.44 correspond to 60% and 56% reductions in risk of progression or death under different regional censoring rules.

The regimen is chemotherapy-free, which may be clinically meaningful in a heavily pretreated population if tolerability remains favorable. The safety profile was described as consistent with prior experience for each agent, suggesting no major new safety signals in the topline readout.

Genmab and AbbVie intend to engage global regulators, and the strength of the PFS data and very low p values (<0.0001) could underpin supplemental approval filings. Subsequent detailed data presentations and regulatory interactions will clarify durability of benefit, overall survival trends and how broadly this regimen might fit into DLBCL treatment algorithms.

Key Figures

Risk reduction (U.S. censoring): 60% reduction (HR 0.40) Risk reduction (ex-U.S. censoring): 56% reduction (HR 0.44) Statistical significance (U.S.): p < 0.0001 +3 more

6 metrics

Risk reduction (U.S. censoring) 60% reduction (HR 0.40) Progression or death risk in EPCORE DLBCL-4 vs R-GemOx

Risk reduction (ex-U.S. censoring) 56% reduction (HR 0.44) Progression or death risk in EPCORE DLBCL-4 vs R-GemOx

Statistical significance (U.S.) p < 0.0001 PFS primary endpoint under U.S. censoring rules

Statistical significance (ex-U.S.) p < 0.0001 PFS primary endpoint outside U.S. censoring rules

Trial phase Phase 3 EPCORE DLBCL-4 epcoritamab plus lenalidomide study

Trial start date August 13, 2024 EPCORE DLBCL-4 initiation; trial is ongoing

Key Terms

progression-free survival, relapsed/refractory diffuse large B-cell lymphoma, T-cell engaging bispecific antibody, chemoimmunotherapy, +2 more

6 terms

progression-free survival clinical

"demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS)"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

relapsed/refractory diffuse large B-cell lymphoma clinical

"in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL)"

T-cell engaging bispecific antibody clinical

"epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously"

A T-cell engaging bispecific antibody is a lab-designed protein with two different “binding sites” that acts like a bridge between a patient’s T cells (immune cells that kill infected or abnormal cells) and a target cell such as a cancer cell, bringing them into close contact so the T cell can destroy the target. For investors this matters because these drugs can offer precise, potentially high-impact cancer treatments with correspondingly large market and regulatory upsides, but they also carry development, safety and approval risks that strongly affect company value.

chemoimmunotherapy clinical

"compared to chemoimmunotherapy, rituximab plus gemcitabine plus oxaliplatin (R-GemOx)"

Chemoimmunotherapy is a cancer treatment approach that combines drugs that directly kill tumor cells with medicines that boost or guide the patient’s immune system to recognize and attack cancer. For investors, it matters because combining these two approaches can change clinical trial outcomes, regulatory paths, potential sales and pricing, and the risk/reward profile of drug candidates much like adding a second player to a team can improve performance but also complicate strategy and costs.

autologous stem cell transplantation clinical

"failed or relapsed after, or were not a candidate for autologous stem cell transplantation (ASCT)"

A procedure that collects a patient’s own stem cells, stores them, and then returns them after intensive treatment that wipes out diseased or malfunctioning cells. Think of it like saving seeds before clearing a garden and replanting them afterward to restore growth. Investors watch this because demand, costs, and outcomes influence sales of related drugs, devices and services, reimbursement decisions, and the commercial potential of new therapies.

T-cell-mediated killing clinical

"induces T-cell-mediated killing of CD20+ cells"

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Form 6-K: How Foreign Companies Report to the SEC →

Available on EDGAR 06/29/2026 - 04:24 PM Accepted by SEC EDGAR 06/29/2026 - 04:24 PM

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16

OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE MONTH OF JUNE 2026

COMMISSION FILE NUMBER 001-38976

Genmab A/S
(Exact name of Registrant as specified in its charter)

Carl Jacobsens Vej 30

2500 Valby

Denmark

+45 70 20 27 28
(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F Form 40-F

This report on Form 6-K shall be deemed to be incorporated by reference in Genmab A/S’s registration statements on Form S-8 (File No. 333-232693, 333-253519, 333-262970, 333-277273, 333-284876 and 333-293505) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

EXHIBIT INDEX



Exhibit			Description of Exhibit

99.1			Company Announcement Dated June 29, 2026

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.



			GENMAB A/S

			BY:			/s/ Anthony Pagano
						Name: Anthony Pagano
						Title: Executive Vice President & Chief Financial Officer

DATE: June 29, 2026

Exhibit 99.1

Genmab Announces Positive Phase 3 Results for Epcoritamab Plus Lenalidomide in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Demonstrating Statistically Significant Improvement in Progression-Free Survival

Company Announcement

•Topline results from Phase 3 EPCORE® DLBCL-4 evaluating epcoritamab in combination with lenalidomide demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with relapsed/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

COPENHAGEN, Denmark; June 29, 2026 – Genmab A/S (Nasdaq: GMAB) today announced topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating the combination of fixed duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, and lenalidomide, compared to standard-of-care, 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 treatment. Based on topline results, the trial met its primary objective, 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 previously reported safety profiles of the individual agents (epcoritamab or lenalidomide).

“These topline results add to the growing evidence supporting the versatility of epcoritamab-based combinations, including fixed-duration epcoritamab, across lines of therapy for patients with relapsed or refractory large B-cell lymphoma who received at least one prior treatment,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “With each new combination and treatment setting, we are building on our vision for epcoritamab as a core therapy across B-cell malignancies. We look forward to engaging with regulatory authorities as we continue to advance this program.”

Genmab and AbbVie will engage global regulatory authorities. 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. The trial started on August 13, 2024, and is ongoing.

More information on this trial can be found at https://clinicaltrials.gov/study/NCT06508658 (NCT: NCT06508658).

About Diffuse Large B-Cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL) DLBCL is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases.[i],[ii] In the U.S., there are


Genmab A/S Carl Jacobsens Vej 30 2500 Valby, Denmark			Tel: +45 7020 2728 www.genmab.com			Company Announcement no. 32 Page 1/3 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122

approximately 25,000 new cases of DLBCL diagnosed each year.[iii] 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.[iv],[v] 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, treatment management can remain a challenge.iv,[vi]

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.[vii]

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 more than 65 territories. Where approved, epcoritamab is a readily accessible therapy. 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 R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several ongoing Phase 3, open-label, randomized trials, among them a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976) 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 have not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

Please see local country prescribing information for all labeled indication and safety 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:
Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs

T: +1 609 524 0065; E: mmp@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E: acn@genmab.com


Genmab A/S Carl Jacobsens Vej 30 2500 Valby, Denmark			Tel: +45 7020 2728 www.genmab.com			Company Announcement no. 32 Page 2/3 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122

The Company Announcement 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 pre-clinical 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 the Company Announcement 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®.

[i] Lymphoma Research Foundation. Diffuse Large B-Cell Lymphoma. Accessed February 2026. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/dlbcl/

[ii] Padala, et al. Diffuse Large B-Cell Lymphoma. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. 2023 Apr 24.

[iii] Leukemia and Lymphoma Society. Diffuse Large B-Cell Lymphoma (DLBCL). Accessed February 2026. https://www.lls.org/research/diffuse-large-b-cell-lymphoma-dlbcl

[iv] Sehn, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384:842-858. doi: 10.1056/NEJMra2027612.

[v] 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.

[vi] 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.

[vii] 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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What did Genmab (GMAB) announce in its June 2026 6-K filing?