Genmab's Epcoritamab Combination Therapy Shows Promising Results

COPENHAGEN, Denmark; June 15, 2025 – Genmab A/S (Nasdaq: GMAB) has announced significant findings from its Phase 1b/2 EPCORE® NHL-2 trial, revealing that the investigational treatment combining epcoritamab with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) achieved an overall response rate (ORR) of 87% and a complete response (CR) rate of 65% in patients suffering from relapsed or refractory diffuse large B-cell lymphoma (DLBCL) eligible for autologous stem cell transplantation (ASCT). The data was presented during an oral session at the 30th European Hematology Association (EHA) Congress.

The EPCORE NHL-2 trial, which evaluated the efficacy of epcoritamab—a bispecific antibody designed to engage T-cells—demonstrated its potential in increasing the number of patients qualifying for ASCT. The study involved 31 adult patients who had undergone prior treatments and were facing high-risk disease, with 65% of participants progressing within 12 months after initial treatment. Remarkably, at the six-month mark, 81% of responses remained ongoing, and 74% of patients were progression-free, with 100% survival reported.

Dr. Raul Cordoba, MD, PhD, Head of the Lymphoma Unit at the Fundación Jiménez Díaz University Hospital in Madrid, emphasized the significance of these findings, stating, "These results are particularly encouraging because many patients in this study had high-risk disease, having progressed rapidly after initial treatment. This combination therapy offers a potential new treatment option for patients with relapsed/refractory DLBCL."

The study also noted a manageable safety profile, with cytokine release syndrome (CRS) occurring in 52% of patients, all classified as low grade. Other treatment-emergent adverse events (TEAEs) included neutropenia (74%), anemia (68%), and thrombocytopenia (68%). Importantly, there were no incidents of Grade 5 TEAEs reported.

As Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab, stated, "The results from this trial highlight the potential of epcoritamab, especially for patients who progress quickly after initial treatment, reinforcing our collaborative efforts with AbbVie to develop this therapy for B-cell lymphomas."

Diffuse Large B-Cell Lymphoma, the most prevalent non-Hodgkin’s lymphoma worldwide, accounts for approximately 25-30% of all NHL cases, with around 25,000 new diagnoses annually in the United States alone. DLBCL is characterized by its rapid progression and can occur in various lymphatic and non-lymphatic organs, primarily affecting older adults.

The EPCORE NHL-2 trial is a critical component of Genmab's ongoing commitment to advancing epcoritamab as both a monotherapy and in combination therapies for a range of hematologic malignancies. Epcoritamab, which utilizes Genmab’s proprietary DuoBody® technology, is designed to target CD3 on T-cells and CD20 on B-cells, facilitating T-cell-mediated destruction of malignant B-cells.

While these findings present a promising avenue for treatment, it is essential to note that the use of epcoritamab in combination with R-ICE for patients with R/R DLBCL eligible for ASCT has not yet received approval, and its safety and efficacy in this context remain to be established through further investigation.

In conclusion, the results from the EPCORE NHL-2 trial signify a hopeful advancement in the treatment landscape for relapsed/refractory DLBCL, offering potential pathways for improved patient outcomes and paving the way for future research endeavors in this challenging field. As Genmab continues to explore the therapeutic landscape for this innovative treatment, the medical community watches closely for further developments.