Genmab’s Epcoritamab Outperforms Standard Care in Pivotal Phase 3 Lymphoma Trial

2026-01-17 companies

Copenhagen, Friday, 16 January 2026.
Epcoritamab becomes the first bispecific antibody monotherapy to demonstrate improved progression-free survival in refractory large B-cell lymphoma, reducing progression risk by 26% versus standard chemotherapy.

A Pivot Point in Lymphoma Treatment

Genmab A/S (GMAB) has marked a significant milestone in the treatment of hematological malignancies today, Friday, January 16, 2026, by announcing positive topline results from its global Phase 3 EPCORE DLBCL-1 trial [1][2]. The study evaluated epcoritamab, a T-cell engaging bispecific antibody, as a monotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) [1]. The data reveals that the trial met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to standard chemotherapy regimens [2][3]. This development positions epcoritamab as the first bispecific antibody monotherapy to show such efficacy benefits in this difficult-to-treat patient population, signaling a potential shift away from traditional chemotherapy-based approaches for recurrent disease [1].

Analyzing the Clinical Data

The EPCORE DLBCL-1 trial, which commenced on January 13, 2021, enrolled 483 patients with relapsed or refractory DLBCL who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT) [1][2]. The results showed a Hazard Ratio (HR) for progression-free survival of 0.74 [95% CI 0.60 to 0.92], representing a 26% reduction in the risk of disease progression or death compared to the investigator’s choice of chemotherapy [1][3]. While the study succeeded in its primary objective, the data regarding overall survival (OS) showed a Hazard Ratio of 0.96 [95% CI 0.77 to 1.20], which did not reach statistical significance at this analysis [1][3]. The control arm in this open-label study utilized standard-of-care regimens, specifically either rituximab plus gemcitabine and oxaliplatin (R-GemOx) or bendamustine plus rituximab (BR) [2].

Strategic Implications and Market Position

This announcement reinforces the commercial and clinical trajectory of epcoritamab, which is already approved under the brand name EPKINLY in the United States and Japan, and TEPKINLY in the European Union [1][2]. Following today’s results, Genmab and its partner AbbVie intend to engage with global regulatory authorities to discuss the next steps for expanded commercialization [2]. As of yesterday, January 15, 2026, Genmab’s stock was trading at $33.85, reflecting a market capitalization of approximately $21.77 billion [3]. Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab, highlighted the historic nature of the data, noting that this is the first Phase 3 study to validate a bispecific antibody monotherapy’s ability to improve progression-free survival in this specific patient setting [1].

Mechanism and Patient Impact

Epcoritamab functions as a bispecific T-cell engager (BiTE), targeting both CD3 on T-cells and CD20 on B-cells to direct the body’s immune system against malignant cells [4]. This mechanism offers a “chemo-free” alternative to patients who have often exhausted multiple prior lines of therapy; in the EPCORE DLBCL-1 trial, 73% of participants had received two or more previous treatments [2]. Experts note that the therapy’s off-the-shelf availability and outpatient administration model could significantly improve quality of life by reducing hospitalizations compared to complex cellular therapies like CAR-T [5]. However, the treatment does carry warnings for side effects such as Cytokine Release Syndrome (CRS) and neurologic problems, necessitating careful monitoring, particularly after the first full dose [2].

Summary

Today’s release of Phase 3 data from Genmab validates the efficacy of epcoritamab monotherapy in reducing the risk of disease progression by 26% in patients with relapsed or refractory DLBCL [1][3]. While overall survival data did not reach statistical significance, the improvement in progression-free survival over standard chemotherapy marks a critical advancement for patients with limited options [1]. Looking ahead, Genmab anticipates further data in 2026 from the EPCORE DLBCL-2 and EPCORE DLBCL-4 trials, which will evaluate fixed-duration regimens and potentially broaden the therapy’s application [1][2].

Sources

Biotechnology Oncology