A new antibody (Odronextamab) for the treatment of B-cell non-Hodgkin lymphomas in patients who have already received prior treatment

B-cell non-Hodgkin lymphomas (NHL) are a group of malignant diseases of B lymphocytes, a subtype of white blood cells that are part of the immune system. There are various subtypes of NHL, including follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL). There are also other, rarer forms. The clinical presentation of these diseases varies widely. Symptoms may include nonspecific complaints such as swollen lymph nodes, fever, increased night sweats, weight loss, or an increased susceptibility to infections. In other cases, however, patients report being completely symptom-free. The exact cause of NHL is unknown, but genetic factors and environmental factors may play a role. Standard treatment for NHL often includes chemotherapy and immunotherapy. Although patients often respond well to treatment, the disease may not respond to therapy (refractory) or may return after initial success (recurrence).

Odronextamab is a so-called bispecific antibody that can both bind to cancer cells and stimulate the immune system. To do this, it targets surface markers on both the cancer cells and the body’s own immune cells. This drug is already approved for the treatment of relapsed/refractory FL and DLBCL after at least two prior lines of therapy.

The goal of the ELM-2 study is to gather further data on efficacy and safety while also investigating odronextamab for other diseases. The study will therefore evaluate the efficacy and safety of odronextamab in patients with one of the above-mentioned NHLs who have already received standard therapy and are now refractory or have relapsed. Odronextamab is administered via an intravenous line. Patients will be assigned to a treatment cohort based on their disease. The exception is the first 68 patients with DLBCL, who will be assigned randomly. Treatment as part of the study lasts for up to 52 weeks, during which the efficacy of the therapy and the occurrence of side effects from the drug are evaluated. A key factor is whether or when the disease progresses again during therapy. Patients aged 18 and older with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or another subtype of NHL. The disease must either be refractory or have recurred. The number of prior treatments required varies by cohort (e.g., at least 2 for FL and DLBCL).