AbbVie announces updated results from Phase 1b/2 EPCORE NHL-2 trial

AbbVie (ABBV) announced updated results from the Phase 1b/2 EPCORE NHL-2 trial evaluating fixed-duration investigational epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, plus lenalidomide + rituximab in adult patients with relapsed or refractory follicular lymphoma. Among 111 patients with a median follow-up of over two years, overall response rate was 96%, and complete response rate was 87%. The data were shared during an oral presentation at the 66th Annual Meeting and Exposition of the American Society of Hematology. This study’s primary endpoint was ORR per Lugano criteria, and adult patients with R/R FL received subcutaneous epcoritamab + R2 for up to 12 cycles, followed by 12 additional cycles of epcoritamab monotherapy. Among 111 patients with a median follow-up of over two years, the ORR was 96%, and the CR rate was 87%. At 18 months an estimated 89% of complete responders to the combination therapy remained in CR, 41 patients completed treatment per protocol. Minimal residual disease analysis from blood samples showed that 88% of patients were MRD negative, indicating no detectable disease at 10-6 threshold. COVID-19 was reported in 57% of patients and led to epcoritamab discontinuation in 13% of patients. Five cases of COVID-19 led to fatal treatment-emergent adverse events. All CRS cases resolved. One case of immune effector cell-associated neurotoxicity syndrome was reported. The CRS and ICANS cases did not lead to treatment discontinuation.