Genmab's Epcoritamab Hits Key Goal in Advanced Lymphoma Study

COPENHAGEN, Denmark – January 16, 2026 – Genmab and its partner AbbVie today announced a significant clinical victory for their antibody therapy, epcoritamab, in a late-stage trial for patients with an aggressive and hard-to-treat form of blood cancer. The Phase 3 study showed that the drug successfully slowed cancer progression in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), marking a potential turning point for a patient population with limited options.

The topline results from the EPCORE® DLBCL-1 trial revealed that epcoritamab, administered as a monotherapy, met its primary goal of improving progression-free survival (PFS) compared to standard chemoimmunotherapy. This achievement makes epcoritamab the first T-cell engaging bispecific antibody of its kind to demonstrate such a benefit in a Phase 3 trial for this specific disease, heralding a new era for targeted cancer treatments.

A Clinical Breakthrough for a Challenging Cancer

Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma globally, affecting tens of thousands of new patients each year in the U.S. alone. While initial treatments can be effective, a substantial number of patients see their cancer return (relapse) or stop responding to treatment (refractory), creating a dire need for new therapeutic strategies.

The EPCORE DLBCL-1 trial enrolled 483 such patients, all of whom were ineligible for intensive treatments like high-dose chemotherapy and stem cell transplants. The results showed that patients treated with epcoritamab had a 26% lower risk of their disease progressing or death compared to those receiving the investigator's choice of standard chemotherapy regimens (Hazard Ratio: 0.74). The study also reported positive trends in other key measures, including higher complete response rates and longer duration of response for patients on epcoritamab.

However, the data also presented a point of nuance. While the drug significantly held the cancer at bay, it did not demonstrate a statistically significant improvement in overall survival (OS), a critical secondary endpoint. Genmab noted that a full analysis is underway to understand this result, considering potential confounding factors such as the COVID-19 pandemic's impact during the trial period and the increasing availability of other novel lymphoma therapies that patients may have received after the study.

“The EPCORE DLBCL-1 trial is the first Phase 3 study evaluating a bispecific antibody monotherapy to demonstrate improvements in progression-free survival in patients with relapsed or refractory DLBCL,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “The results from this global trial contribute to the growing body of evidence supporting epcoritamab and build upon the robust foundation established by epcoritamab, which has been used to treat thousands of patients in need of additional therapeutic options.”

Reshaping the Treatment Landscape

The positive PFS data positions epcoritamab as a formidable new option in the R/R DLBCL treatment arsenal. Its mechanism of action represents a sophisticated approach to immunotherapy. Created with Genmab's proprietary DuoBody® technology, epcoritamab is a bispecific antibody designed to act as a bridge, simultaneously binding to the CD20 protein on cancerous B-cells and the CD3 protein on the patient’s own T-cells. This dual-action design effectively directs the body's immune soldiers to find and destroy the lymphoma cells.

This approach offers a key practical advantage over other advanced treatments like CAR-T cell therapy. While highly effective, CAR-T therapies are complex, costly, and require a lengthy process of harvesting, re-engineering, and re-infusing a patient's own T-cells. In contrast, epcoritamab is an "off-the-shelf" product that can be administered via a simple subcutaneous injection, making it far more accessible and convenient for both physicians and patients.

The drug, already approved in over 65 countries for other lymphoma indications under the brand names EPKINLY® and TEPKINLY®, has an established safety profile. The adverse events seen in the EPCORE DLBCL-1 trial were reportedly consistent with what is already known, providing a degree of predictability for clinicians.

Navigating the Path to Market and Patient Access

With these positive Phase 3 results in hand, Genmab and AbbVie will now engage with global regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to discuss the next steps for a potential new indication in R/R DLBCL. Regulators will likely conduct a thorough review, weighing the significant and clinically meaningful improvement in progression-free survival against the lack of a demonstrated overall survival benefit in this initial data cut.

The full trial results, which will be presented at a future medical conference, will be critical in shaping these regulatory discussions and informing clinical opinion. For patient advocacy groups like the Lymphoma Research Foundation, this development represents a beacon of hope for a community constantly seeking better, more tolerable, and more accessible treatments.

Should epcoritamab gain approval for this indication, the focus will shift to ensuring broad patient access. This involves navigating the complex web of pricing negotiations, insurance reimbursement policies, and integration into standard clinical practice guidelines. The convenience of its subcutaneous delivery could play a significant role in its adoption, particularly in community oncology settings outside of major academic medical centers.

A Strategic Win Amid Market Scrutiny

From a business perspective, the trial success is a major strategic victory for the Genmab-AbbVie partnership, strengthening their foothold in the competitive and lucrative hematology-oncology market. However, the market's initial reaction was muted. Genmab's shares saw a dip on the day of the announcement, a move some analysts attribute to profit-taking after a year of strong stock performance or to investors focusing narrowly on the non-significant overall survival data.

Despite the short-term market volatility, the long-term outlook for Genmab remains bright, according to many financial analysts. The company boasts a strong balance sheet and robust revenue growth, and the positive epcoritamab data adds significant value to its deep clinical pipeline. The partnership with pharmaceutical giant AbbVie provides the commercial muscle needed for a global launch and broad market penetration.

This trial is just one part of a broader development strategy for epcoritamab. Genmab and AbbVie are already looking to the future, with two more pivotal Phase 3 trials in DLBCL expected to report data later in 2026. One study is evaluating epcoritamab in combination with standard chemotherapy for newly diagnosed patients, while another is testing it in combination with other targeted agents for the relapsed/refractory population. Success in these trials could firmly establish epcoritamab not just as a late-line option, but as a core therapy across the entire DLBCL treatment journey.