AbbVie and Genmab have said that their Phase 3 trial of epcoritamab in newly diagnosed diffuse large B-cell lymphoma (DLBCL) met its primary efficacy goal, with the treatment combination cutting the risk of disease progression or death by 51%.

 

The EPCORE DLBCL-2 trial found that fixed-duration epcoritamab, a subcutaneous T-cell-engaging bispecific antibody, combined with standard R-CHOP chemotherapy produced a statistically significant and clinically meaningful improvement in progression-free survival compared with R-CHOP alone.

 

The safety profile of epcoritamab combined with R-CHOP was generally well tolerated and consistent with the known safety profiles of the individual treatments, AbbVie and Genmab said.

 

"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," said Daejin Abidoye, 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."

 

The companies said the results represent the first Phase 3 study to show a statistically significant improvement in progression-free survival for newly diagnosed DLBCL patients treated with a bispecific antibody combination.

 

"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," said 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."

 

Gilles Salles, Chief of the Lymphoma Service and holder of the Steven A. Greenberg Chair at Memorial Sloan Kettering Cancer Center, said the findings could have implications for frontline treatment of the disease.

 

"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," said Gilles Salles, 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."

 

The results came from the first planned efficacy interim analysis of EPCORE DLBCL-2. In light of the significant benefit, the trial's Independent Data Monitoring Committee recommended that the study be unblinded.