The US Food and Drug Administration (FDA) has granted priority review to 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 phase 2 EPCORE NHL-1 trial (ClinicalTrials.gov Identifier: NCT03625037), which was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma.
Results showed an overall response rate (ORR) of 63% and a complete response (CR) rate of 39% among patients who had previously received at least 2 prior lines of systemic anti-lymphoma therapy. Among patients who were naive to treatment with chimeric antigen receptor (CAR) T cells, the ORR was 69% and the CR rate was 42%. For patients previously treated with CAR T-cell therapy, the ORR was 54% and the CR rate was 34%.
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At 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 a CR, with 89% still in CR at 9 months.
The most common treatment-emergent adverse events (TEAEs) of any grade were 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.
A prescription drug user fee act target date of May 21, 2023, has been set for the application.
References
- 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.
This article originally appeared on MPR
