Arzerra (0fatumumab) is a human, anti-CD20 monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) to treat chronic lymphocytic leukemia (CLL) either as a single therapy or in combination with other treatments.

It was developed and is marketed by Genmab under a co-development and commercialization agreement with Novartis.

Ofatumumab is currently under clinical investigation to potentially treat other diseases, including relapsing multiple sclerosis (RMS), Crohn’s disease, Wegener’s granulomatosis, and several types of B-cell non-Hodgkin’s lymphoma (NHL).

Like lymphomas, lymphocytic leukemias start in certain white blood cells of the bone marrow known as lymphocytes. The main difference between lymphocytic leukemias and lymphomas is that in leukemia, the cancer cells are mainly in the bone marrow and blood, while in lymphoma they tends to be in lymph nodes and other tissues.

How Arzerra works

B-cell NHL originates in the B-cells at the lymph nodes. B-cells, a type of immune system cell, are responsible for combating the infections or threats against the body through the production of specialized proteins called antibodies. In cancers such as this, B-cells can overproliferate and treatment is needed to reduce their number.

Arzerra works by binding to the CD20 molecule present on the surface of B-cells, directing the body’s immune system to fight both normal and cancerous B-cells. This mechanism kills cells in a process known as cell lysis, reducing the number of B-cells — which are produced in overabundance in cancers like CLL.

Arzerra in clinical trials

The FDA approved Arzerra for previously treated CLL patients  who were no longer responding to chemotherapy in 2009. The approval was based on an international multi-center Phase 2 study (NCT00349349), showing that Arzerra provides clinical benefits and is safe in CLL patients with a poor prognosis.

This was followed by Arzerra also being approved as an extended treatment for recurrent or progressive CLL in 2016, and for relapsed CLL in combination with Fludara (fludarabine) and cyclophosphamide, an approval also announced in 2016.

The first of these later approvals was based on data from a Phase 3 study (NCT01039376), finding that patients given Arzerra as a maintenance treatment lived on average 14.2 months longer without disease worsening than those who received no further treatment. Arzerra ‘s approval as a combination therapy was based on results from aPhase 3 study (NCT00824265) demonstrating clinically important improvements in efficacy compared with Fludara plus cyclophosphamide alone. The study also showed a manageable safety profile in patients with previously treated CLL.

Arzerra is also being evaluated in several clinical trials, alone or in combination, as a potential treatment of lymphoma.

The results of a Phase 2 trial (NCT00394836) assessing Arzerra’s safety and efficacy as a monotherapy in rituximab-refractory follicular lymphoma (FL) concluded that Arzerra was well-tolerated, but only modestly active in this group of patients. Researchers suggested the drug should be tested in FL patients who are less refractory, meaning they are more like to respond to treatments.

The results of a Phase 2 (NCT01108341) study of Levact (bendamustine) and Arzerra in untreated B cell NHL demonstrated that the combination therapy was highly active and was adequately tolerated by patients.

A Phase 2 trial (2012-005223-32) in Europe also showed that Arzerra is effective and well-tolerated in patients with MALT lymphoma, and a durable response seen in this pilot study.

Other details

The most common adverse effects associated with the use of Arzerra include infusion site reactions, diarrhea, rash, nausea, fatigue, anemia, upper respiratory tract infections, and abnormally low white blood cell levels that can leave patients at risk of infections.

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