AbbVie has announced positive topline results from the phase 3 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 two to five.
The trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in DLBCL patients with an IPI score of two to five.
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).
This was the first planned efficacy interim analysis of the study and, based on the significant benefit, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study.
DLBCL is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases.
Epcoritamab plus R-CHOP is an investigational combination not approved by regulatory authorities. AbbVie and Genmab will engage global regulatory authorities to determine next steps. Data will be submitted for presentation at a future medical meeting.
