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.
No information available.
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)