Therapy Detail
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| Therapy Name | Epcoritamab-bysp + Lenalidomide |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Epcoritamab-bysp | Epkinly | DuoBody-CD3xCD20|GEN 3013|GEN-3013|GEN3013|epcoritamab | CD20 Antibody 24 CD3 Antibody 99 | Epkinly (epcoritamab-bysp) is a bispecific antibody that targets CD3 and CD20, resulting in T-cell activation and redirection of T-cells to CD20-expressing tumor cells, which may lead to tumor cell cytotoxicity and inhibition of tumor growth (PMID: 31981978, PMID: 33602901). Epkinly (epcoritamab-bysp) is FDA-approved for use in patients with relapsed or refractory diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and follicular lymphoma after two or more lines of systemic therapy (FDA.gov). |
| Lenalidomide | Revlimid | IMiD-1 | Revlimid (lenalidomide) is a thalidomide analog which regulates cytokine production and stimulates T cells and NK cells activity (PMID: 24328678). Revlimid (lenalidomide) is FDA approved for use in multiple myeloma, relapsed or refractory Mantle cell lymphoma, and in combination with a rituximab product in follicular lymphoma and marginal zone lymphoma (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06508658 | Phase III | Gemcitabine + Oxaliplatin + Rituximab Epcoritamab-bysp + Lenalidomide | A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-4) | Recruiting | USA | ROU | POL | HUN | HRV | FRA | BGR | BEL | AUS | 5 |
| NCT06112847 | Phase II | Epcoritamab-bysp + Lenalidomide | Lenalidomide and Epcoritamab for the Treatment of Previously Untreated Follicular Lymphoma | Recruiting | USA | 0 |
| NCT04663347 | Phase Ib/II | Epcoritamab-bysp Cisplatin + Cytarabine + Dexamethasone + Epcoritamab-bysp + Rituximab Epcoritamab-bysp + Gemcitabine + Oxaliplatin Epcoritamab-bysp + Lenalidomide + Rituximab Bendamustine + Epcoritamab-bysp + Rituximab Cyclophosphamide + Doxorubicin + Epcoritamab-bysp + Prednisone + Rituximab + Vincristine Sulfate Epcoritamab-bysp + Lenalidomide | Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (EPCORE™ NHL-2) | Recruiting | USA | SWE | NOR | NLD | ITA | GBR | FRA | FIN | ESP | DNK | CZE | BEL | AUS | 0 |
| NCT05660967 | Phase II | Epcoritamab-bysp Epcoritamab-bysp + Lenalidomide | Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma (EPCORE DLBCL-3) | Recruiting | USA | POL | ITA | GBR | FRA | ESP | DEU | CZE | BEL | AUT | 2 |
| NCT05848765 | Phase II | Bendamustine + Obinutuzumab Epcoritamab-bysp + Lenalidomide Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Bendamustine + Rituximab Cyclophosphamide + Prednisone + Rituximab + Vincristine Sulfate Lenalidomide + Rituximab | Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy (REFRACT) | Recruiting | GBR | 0 |
| NCT04623541 | Phase Ib/II | Epcoritamab-bysp Epcoritamab-bysp + Venetoclax Cyclophosphamide + Doxorubicin + Epcoritamab-bysp + Prednisone + Rituximab + Vincristine Sulfate Epcoritamab-bysp + Lenalidomide | Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome (EPCORE™ CLL-1) | Recruiting | USA | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CZE | BEL | AUS | 0 |
| NCT05283720 | Phase II | Epcoritamab-bysp + Lenalidomide Epcoritamab-bysp + Ibrutinib + Lenalidomide Cyclophosphamide + Doxorubicin + Epcoritamab-bysp + Polatuzumab vedotin-piiq + Prednisone + Rituximab | A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma | Recruiting | USA | NLD | ISR | HUN | FRA | ESP | DNK | DEU | CZE | 3 |
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