AbbVie has reported topline results from the Phase 3 EPCORE DLBCL-1 trial, showing that its T-cell engaging bispecific antibody, epcoritamab, improved progression-free survival (PFS) in adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

 

The global study compared epcoritamab, administered subcutaneously, to investigator’s choice of chemoimmunotherapy. Patients receiving epcoritamab experienced a 24% reduction in risk of disease progression or death. 

 

Improvements were also seen in complete response rates, duration of response, and time to next treatment. However, the trial did not demonstrate a statistically significant improvement in overall survival.

 

“EPCORE DLBCL-1 is the first Phase 3 study to demonstrate improvement in PFS in patients with R/R DLBCL who were treated with a CD3xCD20 T-cell engaging bispecific monotherapy,” AbbVie said. 

 

The trial enrolled 483 patients with at least one prior therapy, 73% of whom had received two or more prior lines, and were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT).

 

Safety data appeared consistent with the known profile of epcoritamab. AbbVie and Genmab noted that factors such as the COVID-19 pandemic, which overlapped with the trial’s conduct during the Omicron wave, and the increasing availability of novel anti-lymphoma therapies, are being evaluated for their potential impact on outcomes.