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Synonyms: epcoritamab-bysp | Epkinly® | GEN-3013 | GEN3013 | Tepkinly®
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.
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| No information available. |
Summary of Clinical Use  |
| 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 |
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For extended ADME data see the following: European Medicines Agency (EMA) |
