AbbVie has released updated findings from the Phase 2 EPCORE® NHL-6 trial assessing whether epcoritamab—a subcutaneously administered T-cell-engaging bispecific antibody—can be safely dosed and monitored in an outpatient setting for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who had received at least one prior systemic therapy, according to the company.
In the study, 88 patients received the first full 48 mg dose of epcoritamab; of these, 81 (92 %) were monitored as outpatients and only 7 (8 %) as inpatients. Cytokine release syndrome (CRS) occurred in 37 patients (40.2 %) across the trial, was predominantly low-grade (Grade 1–2), resolved in a median of two days, and did not lead to treatment discontinuation. Immune cell-associated neurotoxicity syndrome (ICANS) occurred in seven patients (7.6 %), was similarly low-grade, resolved within three days on average, and also did not result in treatment discontinuation.
Efficacy outcomes varied by prior treatment history. Among patients who had received only one prior line of systemic therapy (n = 42), the overall response rate (ORR) was 64.3 % and the complete response (CR) rate was 47.6 %, at a median follow-up of 5.8 months. For those treated after two or more prior lines (n = 50), the ORR was 60.0 % and CR was 38.0 % at a median follow-up of 10.8 months.
The company said that the adverse event profile and efficacy results are consistent with previous epcoritamab studies in relapsed/refractory DLBCL. However, it emphasized that using epcoritamab in the outpatient setting for the first full dose and as monotherapy in second-line treatment is not currently approved by the U.S. FDA or other health authorities.
