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Leo I. Gordon, MD, FACP
Leo I. Gordon, MD, FACP
Posted: Tuesday, November 29, 2022
On November 21, Genmab A/S announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the biologics license application for subcutaneous epcoritamab (DuoBody®-CD3xCD20) for the treatment of patients with relapse or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. The FDA has set a target action date of May 21, 2023. The investigational bispecific antibody is being co-developed by Genmab and AbbVie.
The application is based on safety and preliminary efficacy data from the LBCL cohort of the pivotal EPCORE NHL-1 open-label, multicenter phase II clinical trial evaluating epcoritamab in patients with relapsed, progressive, or refractory CD20-positive mature B-cell non-Hodgkin lymphoma. These results were presented in a late-breaking oral presentation as a part of the Presidential Symposium at the 2022 Annual Meeting of the European Hematology Association (EHA).
At EHA2022, the investigators reported the primary results for 157 patients with B-cell lymphomas. At a median follow-up of 10.7 months, the overall response rate was 63%, with 39% being complete responses. The median duration of response was 12 months; the median duration of response among patients achieving a complete response was not reached, with 89% still in complete response at 9 months. The most common treatment-emergent adverse events of any grade were cytokine-release syndrome (49.7%), pyrexia (23.6%), fatigue (22.9%), neutropenia (21.7%), and diarrhea (20.4%).
An ongoing phase III, open-label, randomized clinical trial is evaluating epcoritamab as a monotherapy in patients with relapsed or refractory diffuse LBCL (ClinicalTrials.gov identifier NCT04628494). In addition, a phase III open-label clinical trial is evaluating epcoritamab in combination in patients with relapsed or refractory follicular lymphoma (NCT05409066).
