Epcoritamab with or without lenalidomide as a new first-line treatment for diffuse large B-cell lymphoma in older adults > 75 years of age

Diffuse large B-cell lymphoma (DLBCL) is a type of non-Hodgkin lymphoma and affects B lymphocytes, a subtype of white blood cells that are part of the immune system. DLBCL is an aggressive type of lymphoma that progresses rapidly and therefore requires immediate treatment; a cure is possible and is the goal of treatment. Patients with newly diagnosed DLBCL are typically treated with a combination of chemotherapy and immunotherapy, such as the R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone). However, this treatment may be too risky for elderly patients or those with certain comorbidities. To date, there have been no effective treatment options for these patients. Epcoritamab is a so-called bispecific antibody that can both bind to cancer cells and stimulate the immune system. Bispecific antibodies are relatively new but are already showing good therapeutic results due to their dual mechanism of action. Epcoritamab is already approved for DLBCL when standard therapy has failed.

The goal of the EPCORE DLBCL-3 Phase 2 trial is to investigate the efficacy and safety of epcoritamab in older patients. It will be administered as first-line therapy. Patients will be randomly assigned to two groups. Group 1 receives only epcoritamab. Group 2 receives epcoritamab in combination with lenalidomide. Lenalidomide is a drug that affects the immune system in various ways, thereby fighting cancer cells; this drug is already approved. The study is open-label, meaning that both the doctor and the patient know which medication is being administered. First, the safety of the medication will be evaluated in a certain number of patients. Subsequently, epcoritamab will be administered for 12 cycles. A cycle lasts 28 days, and the medication is injected under the skin (subcutaneously). In Group 2, lenalidomide is additionally taken as a tablet during the first 21 days of each cycle. Treatment as part of the study lasts for up to 24 months, during which the efficacy of the therapy and the occurrence of side effects from the various medications are evaluated. The key factor is whether or when the disease progresses again during treatment (progression-free survival).

Women and men aged 80 and older with newly diagnosed DLBCL who are not suitable for chemotherapy with anthracyclines (e.g., those included in R-CHOP) are eligible to participate in the study. Patients aged 75 and older may also participate if they already have other relevant medical conditions.