AbbVie reports results from Phase 2 EPCORE NHL-6 trial

AbbVie (ABBV) announced updated results from the Phase 2 EPCORE NHL-6 trial, or NCT05451810, evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of epcoritamab monotherapy, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with relapsed/refractory, or R/R, diffuse large B-cell lymphoma, or DLBCL, who have received at least one prior line of systemic therapy. Results from the study demonstrated that the incidence and severity of cytokine release syndrome, or CRS, and immune cell-associated neurotoxicity syndrome, or ICANS, following treatment with epcoritamab were consistent with previous epcoritamab studies in R/R DLBCL. These results were shared today during a poster presentation at the 13th Society of Hematologic Oncology, or SOHO, Annual Meeting. In the study, 88 patients received the first full dose of epcoritamab monotherapy. Of these, 81 patients were monitored in the outpatient setting and seven in the inpatient setting. Overall, CRS events occurred in 37 of patients during the entire trial period, were primarily low grade, all resolved with a median time of two days, and no events led to treatment discontinuation. ICANS occurred in seven patients, were primarily low grade, all resolved with a median time of three days, and no events led to treatment discontinuation. The study also showed an overall response rate, or ORR, of 64.3% and a complete response, or CR, rate of 47.6%, at a median follow-up of 5.8 months, in patients treated with epcoritamab after only one prior line of systemic therapy. In patients treated with epcoritamab following two or more lines of systemic therapy, with a median follow-up of 10.8 months, the study showed an ORR of 60.0% and a CR rate of 38.0%. Currently, epcoritamab is approved for R/R DLBCL after two or more prior lines of systemic therapy and is being investigated for use in earlier lines of therapy. See approved indication and important safety information below. The use of epcoritamab in an outpatient setting for the first full dose in R/R DLBCL and as monotherapy in DLBCL in the second-line setting has not been approved by the U.S. FDA or any other Health Authority.