AbbVie presents data evaluating epcoritamab across B-cell lymphomas

AbbVie announced data from multiple clinical trials evaluating epcoritamab, an investigational subcutaneous bispecific antibody, alone or in combination for the treatment of patients with relapsed/refractory follicular lymphoma, previously untreated FL, R/R diffuse large B-cell lymphoma, as well as Richter’s syndrome at the 64th American Society of Hematology Annual Meeting. Initial results of investigational epcoritamab in patients with R/R FL and previously untreated FL are part of the EPCORE NHL-2 study, a Phase 1b/2, open-label trial to assess the safety and preliminary efficacy of epcoritamab in combination with other agents in patients with B-cell non-Hodgkin’s lymphoma, including FL. Additional results from the EPCORE NHL-2 study as well as the EPCORE CLL-1 study were presented for investigational epcoritamab in R/R DLBCL and Richter’s syndrome respectively. The EPCORE CLL-1 study is an open-label, multi-center, safety and efficacy trial of epcoritamab in R/R chronic lymphocytic leukemia and Richter’s syndrome. The trial consists of two parts, a dose escalation Phase and an expansion Phase. In the R/R FL arm of the EPCORE NHL-2 trial, 95 percent of efficacy-evaluable patients treated with subcutaneous epcoritamab in combination with rituximab and lenalidomide achieved an overall response rate and 80 percent achieved complete metabolic response. The majority of patients achieved a response at first tumor response assessment and most continued to respond through the latest assessment at the time of data collection. A manageable cytokine release syndrome occurrence was observed with only low-grade events, mainly following the first full dose, all of which resolved. In the previously untreated FL patient arm of the EPCORE NHL-2 trial, 94 percent of efficacy-evaluable patients who received subcutaneous epcoritamab in combination with rituximab and lenalidomide achieved an ORR, including 86 percent achieving CMR as their best overall response. In the trial, the investigational combination therapy showed a manageable CRS occurrence with only low-grade events, all of which resolved. Results from the EPCORE NHL-2 arm evaluating 27 patients with R/R DLBCL who were eligible for autologous stem cell transplant, showed an 85 percent ORR and 67 percent CMR following treatment with the combination of subcutaneous epcoritamab plus standard rituximab, dexamethasone, cytarabine, and oxaliplatin or carboplatin salvage therapy. Preliminary results from the EPCORE CLL-1 trial showed that treatment with subcutaneous epcoritamab monotherapy had promising antitumor activity in 10 patients with Richter’s syndrome, with a 60 percent ORR and a 50 percent CMR rate. Most responses were observed by the first assessment at week six. In the trial, patients experienced only low-grade CRS events, mostly associated with the first full dose, all of which resolved.