Therapy Detail

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Therapy Name Epcoritamab-bysp
Synonyms
Therapy Description

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 and high-grade B-cell lymphoma after two or more lines of systemic therapy (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Epcoritamab-bysp Epkinly DuoBody-CD3xCD20|GEN 3013|GEN-3013|GEN3013 CD20 Antibody 21 CD3 Antibody 90 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 and high-grade B-cell lymphoma after two or more lines of systemic therapy (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
NCT06238648 Phase II Epcoritamab-bysp Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy Not yet recruiting USA 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 | ITA | GBR | FRA | ESP | DEU | BEL | AUT 4
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 | GBR | FRA | ESP | DEU | BEL | AUS 3
NCT04628494 Phase III Gemcitabine + Oxaliplatin + Rituximab Epcoritamab-bysp Bendamustine + Rituximab A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL (EPCORE DLBCL-1) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 14
NCT05206357 Phase I Epcoritamab-bysp Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUS 6
NCT05451810 Phase II Epcoritamab-bysp A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma Recruiting USA 1
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 | NLD | ITA | GBR | FRA | ESP | BEL | AUS 5
NCT03625037 Phase Ib/II Epcoritamab-bysp First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma (EPCORE™ NHL-1) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUS 6


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