The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for epcoritamab (DuoBody®-CD3xCD20) for the treatment of relapsed/refractory large B-Cell lymphoma (LBCL).
Epcoritamab is an IgG1-bispecific antibody designed to bind to CD3 on T cells and CD20 on B cells, inducing T cell mediated killing of CD20+ cells. The BLA is supported by data from the LBCL cohort of the open-label, multicenter phase 2 EPCORE NHL-1 trial (ClinicalTrials.gov Identifier: NCT03625037), which evaluated subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma, including LBCL and DLBCL.
Results showed an overall response rate (ORR) of 63% and a complete response rate (CR) of 39% among patients who had previously received at least 2 prior lines of systemic anti-lymphoma therapy. Among patients who were treatment-naïve to chimeric antigen receptor (CAR) T-cell therapy, the ORR was 69% and CR was 42%. For patients previously treated with CAR T-cell therapy, the ORR was 54% and CR was 34%.
After a median follow-up of 10.7 months, the median duration of response (mDOR) was approximately 12 months; the mDOR was not reached among patients who achieved CR, with 89% still in CR at 9 months.
The most common treatment-emergent adverse events (TEAEs) of any grade included cytokine release syndrome, pyrexia, fatigue, neutropenia, diarrhea, injection site reaction, nausea, and anemia. The most common grade 3 or 4 TEAEs included neutropenia, anemia, decreased neutrophil count, and thrombocytopenia.
“We are pleased that the BLA for epcoritamab has been accepted for Priority Review by the FDA, accelerating the pathway for approval and bringing us one step closer to potentially delivering a novel treatment option to relapsed and refractory LBCL patients who are in need of additional treatment options,” said Jan van de Winkel, PhD, CEO of Genmab.
A Prescription Drug User Fee Act target date of May 21, 2023 has been set for the application.
- Genmab announces US Food and Drug Administration accepts for Priority Review Biologics License Application (BLA) for epcoritamab (DuoBody®-CD3xCD20) for the treatment of relapsed/refractory large B-Cell lymphoma (LBCL). News release. Genmab A/S. Accessed November 21, 2022. https://www.businesswire.com/news/home/20221121005063/en/Genmab-Announces-U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Biologics-License-Application-BLA-for-Epcoritamab-DuoBody%C2%AE-CD3xCD20-for-the-Treatment-of-RelapsedRefractory-Large-B-Cell-Lymphoma-LBCL.
- Genmab announces late-breaking phase 2 trial results of investigational epcoritamab (DuoBody®-CD3xCD20) in relapsed/refractory large b-cell lymphoma (LBCL) patients presented at European Hematology Association (EHA) Presidential Symposium. News release. Genmab A/S. June 11, 2022. Accessed November 21, 2022. https://www.globenewswire.com/news-release/2022/06/11/2460773/0/en/Genmab-Announces-Late-Breaking-Phase-2-Trial-Results-of-Investigational-Epcoritamab-DuoBody-CD3xCD20-in-Relapsed-Refractory-Large-B-cell-Lymphoma-LBCL-Patients-Presented-at-Europea.html.