AbbVie and Genmab said adding epcoritamab to standard R-CHOP treatment reduced the risk of disease progression or death by 51% in a Phase 3 trial involving patients with newly diagnosed diffuse large B-cell lymphoma.
The EPCORE DLBCL-2 study compared a fixed-duration course of epcoritamab plus R-CHOP with R-CHOP alone in patients with International Prognostic Index scores of 2 to 5.
The combination significantly improved progression-free survival, with a hazard ratio of 0.49 and a 95% confidence interval of 0.36 to 0.67. The reported p-value was below 0.0001.
These findings came from the trial’s first planned interim efficacy analysis. An independent data monitoring committee recommended unblinding the study based on the observed benefit.
Epcoritamab is a T-cell-engaging bispecific antibody administered by subcutaneous injection. R-CHOP consists of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone.
The companies said the combination’s safety profile was consistent with previously reported profiles of the individual treatments. They described the regimen as generally well tolerated.
Epcoritamab plus R-CHOP remains an investigational combination and has not been approved by regulatory authorities. AbbVie and Genmab plan to discuss the results with global regulators to determine next steps and submit the data for presentation at a future medical meeting.
According to the companies, EPCORE DLBCL-2 is the first Phase 3 study of a bispecific antibody combination to demonstrate a statistically significant progression-free survival improvement in newly diagnosed diffuse large B-cell lymphoma.
The disease is the most common form of non-Hodgkin lymphoma worldwide, accounting for approximately 25% to 30% of all non-Hodgkin lymphoma cases.
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