Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication EPKINLY is a bispecific CD20-directed CD3 T-cell engager indicated: For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. FDA label
Also known as DuoBody-CD3xCD20, Epcoritamab-bysp, Epkinly, GEN 3013, Tepkinly
Epcoritamab · 3 trials · 16 indications
Using Common Terminology Criteria for Adverse Events version 5.0. Estimate safety and tolerability of combining epcoritamab with dose adjusted etoposide, cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab.
Overall response rate (ORR), defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to the 2014 Lugano Response Criteria following treatment with accelerated ramp-up dosing and fixed-dose epcoritamab in combination with lenalidomide.
Objective Response rate
| Arm | Type | Description |
|---|---|---|
| Treatment (Epcoritamab and EPOCH-R) | EXPERIMENTAL | Patients receive rituximab IV on day 1, prednisone PO BID on days 1-5, etoposide IV and doxorubicin on days 1-4 and cyclophosphamide IV on day 5 of each cycle. Patients also receive epcoritamab SC on days 8 and 15 of cycle 1, days 1, 8 and 15 of cycles 2-4 and day 1 of cycles 5-6. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MUGA scan or echocardiography during screening and receive fludeoxyglucose and undergo PET scan, CT scan, bone marrow biopsy and aspirate (if needed), and blood sample collection throughout the study. |
| Epcoritamab plus Lenalidomide | EXPERIMENTAL | All enrolled participants will be included in a single cohort. No comparator group will be included. |
| experimental/epcoritamab | EXPERIMENTAL | Investigational Medicinal Product (IMP): Epcoritamab will be used during induction phase and Maintenance phase. Auxiliary Medicinal Products (AMP): Rituximab and Lenalidomide Standard use for AMP is: Induction: At cycle 1: Rituximab IV 375mg/m2 Day 1, 8, 15, 22; Lenalidomide 20mg oral route Day 1-Day 21 At cycle 2-3: Day 1: rituximab IV 375mg/m2; Lenalidomide 20mg oral route Day 1-Day 21 At cycle 4-8: Day 1: rituximab IV 375mg/m2; Lenalidomide 20mg oral route Day 1-Day 21 Maintenance: At cycle 9-20: Day 1: Lenalidomide 20mg oral route Day 1-D21 (12 cycles corresponding to one year of maintenance treatment) |
| Name | Type | Description |
|---|---|---|
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Aspiration | PROCEDURE | Undergo bone marrow aspiration |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy |
| Computed Tomography | PROCEDURE | Undergo CT scan |
| Cyclophosphamide | DRUG | Given IV |
| Doxorubicin | DRUG | Given IV |
| Echocardiography Test | PROCEDURE | Undergo echocardiography |
| Epcoritamab | BIOLOGICAL | Given SC |
| Etoposide | DRUG | Given IV |
| Fludeoxyglucose F-18 | OTHER | Given fludeoxyglucose |
| Multigated Acquisition Scan | PROCEDURE | Undergo MUGA scan |
| Positron Emission Tomography | PROCEDURE | Undergo PET scan |
| Prednisone | DRUG | Given PO |
| Rituximab | BIOLOGICAL | Given IV |
| Lenalidomide | DRUG | Lenalidomide will be administered orally in combination with epcoritamab from Cycles 2 through 12. Lenalidomide will be given once daily on Days 1 to 21 of each 28-day cycle, followed by a 7-day rest period (Days 22 to 28). The starting dose will be 20 mg for participants with creatinine clearance (CrCL) ≥60 mL/min and 10 mg for participants with CrCL between 30 and \<60 mL/min, according to the study protocol. |
Inclusion Criteria: * Untreated aggressive large-B cell lymphoma (non-Hodgkin lymphoma) with adverse features that may predict sub-optimal response to R-CHOP and in the opinion of the investigator would be treated with dose adjusted (DA)-EPOCH-R as standard of care. Subjects must be planned to rece...
Epcoritamab is an investigational monoclonal antibody being developed for B-cell cancers, including B-cell non-Hodgkin lymphoma, primary CNS lymphoma, and refractory diffuse large B-cell lymphoma. It is in Phase 2 clinical development and is not yet approved. It is being studied both as a single agent and in combination with other therapies such as lenalidomide and rituximab.
Epcoritamab targets MS4A1, also known as CD20, on B cells, and the CD3 subunits CD3E, CD3G, and CD3D on T cells. By binding both a B-cell surface protein and T-cell receptor components, it is designed to redirect T cells toward malignant B cells. It is classified as a binding agent.
Epcoritamab is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor behind the clinical program evaluating the antibody across several B-cell lymphoma subtypes, including diffuse large B-cell lymphoma and primary CNS lymphoma.
Epcoritamab is in Phase 2 clinical development. It is an investigational monoclonal antibody and has not been approved for any indication. The Phase 2 program includes studies in relapsed or refractory large B-cell lymphoma, aggressive B-cell non-Hodgkin lymphoma, and primary CNS lymphoma.
Epcoritamab is being studied in three Phase 2 trials. NCT07097363 is recruiting and combines epcoritamab with EPOCH-R in aggressive B-cell non-Hodgkin lymphoma in the United States. NCT06931652 is recruiting in primary CNS lymphoma in France. NCT07814001, in France, will test epcoritamab plus lenalidomide after second-line CAR T-cell therapy and is not yet recruiting.
Epcoritamab is being evaluated in B-cell non-Hodgkin lymphoma as an investigational treatment, including in combination with dose-adjusted EPOCH-R chemotherapy and rituximab. The Phase 2 study NCT07097363 is recruiting adults with aggressive B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and high-grade B-cell lymphoma subtypes.