Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 studied in B-cell non-Hodgkin lymphoma, refractory diffuse large B-cell lymphoma (DLBCL), and primary CNS lymphoma (PCNSL). It is being evaluated in relapsed or refractory large B-cell lymphoma after second-line CAR T-cell therapy, in aggressive B-cell non-Hodgkin lymphoma combined with EPOCH-R, and in primary diffuse large B-cell lymphoma of the central nervous system.
Epcoritamab targets MS4A1 (CD20) on B cells and the CD3 subunits CD3E, CD3G, and CD3D on T cells. By binding both a B-cell surface antigen and the T-cell receptor complex, it is designed to redirect T cells toward B-cell lymphoma cells. It is classified as a binding agent and a monoclonal antibody.
Epcoritamab is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating epcoritamab across B-cell non-Hodgkin lymphoma, refractory diffuse large B-cell lymphoma, and primary CNS lymphoma.
Epcoritamab is in Phase 2 clinical development and is investigational. It has received FDA designations of Priority Review, Breakthrough Therapy, and Accelerated Approval. The program includes Phase 2 studies in relapsed or refractory large B-cell lymphoma, aggressive B-cell non-Hodgkin lymphoma, and primary CNS lymphoma.
Epcoritamab is being studied in NCT07814001, a Phase 2 trial of epcoritamab plus lenalidomide in relapsed or refractory large B-cell lymphoma after second-line CAR T-cell therapy, in NCT07097363, a Phase 2 trial combining epcoritamab with dose-adjusted EPOCH-R in aggressive B-cell non-Hodgkin lymphoma, and in NCT06931652, a Phase 2 trial in relapsed or refractory primary CNS lymphoma with lenalidomide and rituximab.
Epcoritamab is investigational and remains in clinical development, with Phase 2 trials ongoing. It holds FDA designations of Priority Review, Breakthrough Therapy, and Accelerated Approval. These designations support the development program but do not by themselves establish approval status for the indications currently under study.