epcoritamab   Click here for help

GtoPdb Ligand ID: 11442

Synonyms: epcoritamab-bysp | Epkinly® | GEN-3013 | GEN3013 | Tepkinly®
Approved drug Immunopharmacology Ligand
epcoritamab is an approved drug (FDA & EMA (2023))
Compound class: Antibody
Comment: Epcoritamab (GEN3013) is a novel CD3ε/CD20 bispecific IgG1 antibody that redirects CD3+ cytotoxic T cells to selectively destroy CD20+ve malignant B cells [1-2]. Its Fc domain has been mutated to prevent FcγR and complement binding.
Summary of Clinical Use Click here for help
Advanced to clinical investigation for efficacy against CD20+ve B cell malignancies, as monotherapy, and in combination with other anticancer drugs [4]. The EMA issued orphan drug designations in 2022, which permitted the use of epcoritamab to treat advanced diffuse large B cell lymphoma (DLBCL) or follicular lymphoma. First approval was granted by the FDA (under their Accelerated Approval program) in May 2023, which indicated epcoritamab-bysp to treat relapsed or refractory DLBCL and high-grade B cell lymphoma.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT04628494 A Phase 3 Trial of Epcoritamab in R/R DLBCL Phase 3 Interventional Genmab
NCT03625037 GEN3013 Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma Phase 1/Phase 2 Interventional Genmab 3
NCT05409066 Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma Phase 3 Interventional AbbVie
NCT05660967 Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma Phase 2 Interventional Genmab
External links Click here for help
For extended ADME data see the following:

European Medicines Agency (EMA)