New Drug Golcadomid for the Treatment of Advanced Follicular Lymphoma

Follicular lymphoma (FL) is a form of non-Hodgkin lymphoma (NHL) in which malignant B lymphocytes accumulate in the lymph nodes. Lymphocytes are a type of white blood cell that is part of the immune system. The cause of FL is not fully understood, but genetic mutations and immune system disorders play a role. This disease is chronic and generally incurable with available standard treatments, but it can often be effectively controlled for a long time. Treatment is tailored to the symptoms and physical condition of the affected patients. Patients with FL in an early (limited) stage usually receive radiation therapy. Standard treatment for advanced-stage disease often involves a combination of chemotherapy and immunotherapy, typically with the antibody rituximab. Golcadomid is a new active ingredient that represents an alternative treatment option and belongs to the group of so-called CELMoD™ agents—these are new immunomodulators that bind to the protein cereblon on cancer cells. These substances work in two ways: They promote the targeted breakdown of cancer-related proteins within the cell while simultaneously strengthening the immune system, particularly T cells and natural killer cells (immune cells). As a result, the tumor cells are directly damaged and simultaneously attacked by the immune system. This medication is already being used for other forms of lymphoma.

The goal of the GOLSEEK-2 study (Phase 2 study) is to further investigate the efficacy and safety of treatment with Golcadomid + rituximab compared to standard chemotherapy + rituximab in a selected treatment group. As part of the study, patients will be randomly assigned to three groups. Group 1 will receive standard immunochemotherapy (R-CHOP regimen). Groups 2 and 3 will each receive rituximab plus golcadomid at different dosages. This is an open-label study, which means that both patients and medical staff know which medications are being administered. The treatments and follow-up examinations as part of the study will take place over a period of up to 1 year, during which the efficacy of the therapy and the occurrence of side effects from the various medications will be evaluated.

Women and men aged 18 and older with untreated stage 2–4 (grade 1–3a) follicular lymphoma are eligible to participate in this study.