AbbVie and Genmab have reported positive topline data from the Phase III EPCORE DLBCL-2 trial of epcoritamab combined with standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients.
The investigational regimen achieved a statistically significant improvement in progression-free survival compared to R-CHOP alone.
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The data compared outcomes between fixed-duration epcoritamab plus R-CHOP against R-CHOP alone in individuals presenting with an International Prognostic Index (IPI) score from 2 to 5.
Findings from the interim analysis indicate that the combination led to a 51% reduction in the risk of progression or death versus standard therapy.
The safety profile observed was broadly consistent with what is already known about the separate agents.
AbbVie vice-president and oncology, solid tumour and haematology therapeutic area head Daejin Abidoye 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.
“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.”
Following the analysis, the Independent Data Monitoring Committee recommended that the study be unblinded due to the significant benefit observed.
The companies intend to share the full data set at a future medical meeting and will consult with regulatory authorities worldwide on the investigational combination’s next steps.
The EPCORE DLBCL-2 trial is a global, open-label, randomised study enrolling patients with DLBCL and related B-cell lymphomas, randomising them 2:1 to receive epcoritamab plus R-CHOP or R-CHOP alone.
Patients received six cycles of the allocated combination, followed by additional cycles of epcoritamab or rituximab. The trial began in February 2023 and is ongoing.
Epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, is developed jointly by AbbVie and Genmab. The combination with R-CHOP is currently investigational and not approved for use in this setting.
