REG-Genmab and AbbVie Announce Epcoritamab in Combination with R-CHOP Demonstrates Statistically Significant Improvement in Progression-Free Survival in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma
Key Highlights
- ➤Epcoritamab plus R-CHOP reduced progression or death risk 51% in frontline DLBCL
- ➤Phase 3 trial showed statistically significant, clinically meaningful PFS improvement
- ➤Primary endpoint population’s progression or death risk fell 51%; HR 0.49, p-value < 0.0001
- ➤Genmab and AbbVie will engage global regulators on next steps
- ➤Epcoritamab plus R-CHOP remains an investigational, unapproved combination
Expert Statements
Jan van de Winkel, Chief Executive Officer of Genmab
“These topline results of epcoritamab in combination with R-CHOP mark the first Phase 3 study to demonstrate a statistically significant improvement in progression-free survival in patients with newly diagnosed DLBCL treated with a bispecific antibody combination and have the potential to reshape the frontline treatment landscape”
Jan van de Winkel, Chief Executive Officer of Genmab
“While treatment advances have improved outcomes for patients with diffuse large B-cell lymphoma, options for newly diagnosed patients remain limited, reinforcing the need for additional therapies that can treat as many patients as possible in the frontline setting.”
Daejin Abidoye, MD, vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie
“DLBCL is an aggressive disease and the need to advance treatment options is critical. These positive topline results suggest that epcoritamab combined with R-CHOP could offer a potential new standard of care in newly diagnosed DLBCL patients”
Daejin Abidoye, MD, vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie
“The findings further strengthen our understanding and potential of bispecifics across the lymphoma treatment landscape, as we work to address urgent needs in this patient population.”
Gilles Salles, MD, PhD, Chief of the Lymphoma Service and holder of the Steven A. Greenberg Chair at Memorial Sloan Kettering Cancer Center
“As an investigator with firsthand experience in both the landmark trial that established R-CHOP as a standard of care nearly 25 years ago and EPCORE DLBCL-2, it is particularly meaningful to see the potential benefit of bispecific antibody therapy in newly diagnosed diffuse large B-cell lymphoma”
Gilles Salles, MD, PhD, Chief of the Lymphoma Service and holder of the Steven A. Greenberg Chair at Memorial Sloan Kettering Cancer Center
“The 51% reduction in the risk of progression or death is clinically meaningful and highly relevant to everyday practice. These results have the potential to be practice-changing and could mark an important step forward in bringing the opportunity of cure to more patients.”
COPENHAGEN, Denmark and NORTH CHICAGO, Ill.; October 5, 2026 * EPCORE DLBCL-2 is the first Phase 3 study of a bispecific antibody combination therapy to demonstrate statistically significant and clinically meaningful improvement in progression-free survival (PFS) in frontline diagnosed diffuse large B-cell lymphoma (DLBCL) patients * Based on the topline results, Genmab and AbbVie will engage global regulatory authorities Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) announced today positive topline results from the Phase 3 EPCORE DLBCL-2 trial evaluating fixed treatment duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with standard of care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP), compared to R-CHOP alone, in newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL) with an International Prognostic Index (IPI) score of 2 to 5. The trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in DLBCL patients with an IPI score of 2 to 5. The risk of disease progression or death was reduced by 51% (HR 0.49 [95% CI 0.36, 0.67]; p-value < 0.0001). The safety profile of epcoritamab when administered in combination with standard of care R-CHOP was generally well tolerated and consistent with the previously reported safety profiles of the individual agents (epcoritamab and R-CHOP).
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