Genmab and AbbVie have announced updated data presented at ASH from the companies’ ongoing Phase I/II EPCORE NHL-1 clinical trial investigating epcoritamab (DuoBody CD3xCD20).
Epcoritamab is a T-cell engaging bispecific antibody administered subcutaneously in 128 adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL), including follicular lymphoma (FL). Results demonstrated an overall response rate (ORR) of 82%, a complete response (CR) rate of 63% and minimal residual disease (MRD) negativity rate of 67% in patients with relapsed/refractory (R/R) follicular lymphoma (FL).
“Despite treatment advances for patients with follicular lymphoma whose disease has unfortunately progressed, treating relapsed or refractory follicular lymphoma remains highly challenging, particularly in the third-line plus setting,” said Dr Catherine Thieblemont, Head of the Hemato-oncology Department, Paris University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP). “The patients in this trial represent a historically difficult-to-treat patient population. The data presented today are especially notable because they demonstrated high overall and complete response rates for this investigational follicular lymphoma therapy and a preview for its potential as an alternative treatment option.”
EPCORE NHL-1 is an open-label, multi-centre safety and preliminary efficacy trial of epcoritamab that consists of three parts: a Phase I first-in-human, dose escalation part; a Phase IIa expansion part; and a Phase IIa dose optimisation part.
The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (B-NHL), including FL. In the Phase IIa expansion part, additional patients were enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who have limited therapeutic options.
The dose optimisation part evaluates the potential for alternative step-up dosing regimens to help further minimise Grade 2 cytokine release syndrome (CRS) and mitigate Grade ≥3 CRS. The primary endpoint of the expansion part was ORR as assessed by an IRC. Secondary efficacy endpoints included DOR, complete response rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were also evaluated as secondary efficacy endpoints.