New Drug (Odronextamab) for the Treatment of Previously Untreated Follicular Lymphoma (FL)

Follicular lymphoma (FL) is a type 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. Treatment is tailored to the symptoms and overall health of the affected patients. Standard treatment often involves a combination of chemotherapy and immunotherapy. Typical treatment regimens include, for example, R-CHOP and R-bendamustine. In cases of relapsed disease or a refractory form of FL, a newly approved treatment option is the administration of odronextamab. Odronextamab is a bispecific antibody that targets cancer cells (CD20) while simultaneously stimulating the immune system (T cells via CD3). This drug is not yet approved for first-line treatment.

The goal of the OLYMPIA-1 study is to investigate the efficacy and safety of odronextamab compared to standard therapies in patients with FL who have not yet received any treatment (first-line therapy). In the first part of the study (Phase 1b), all patients will receive odronextamab to assess dose-limiting adverse events (within 35 days) and treatment-related adverse events (within 2 years). Patients will then be randomly assigned to two groups as part of the second part of the study (Phase 3 study). Group 1 will receive odronextamab, and Group 2 will receive standard immunochemotherapy (selected by the physician, e.g., R-CHOP or R-bendamustine) followed by rituximab maintenance therapy. The study is open-label, meaning that both the medical staff and the patient know which medications are being administered. Treatments and follow-up examinations as part of the second phase of the study will take place over a period of up to 2.5 years, during which the efficacy of the therapy and the occurrence of side effects from the various medications will be evaluated.

Men and women aged 18 and older with untreated follicular lymphoma are eligible to participate in this study. There must be no involvement of the central nervous system (CNS).