Canakinumab is a prescription medicine from Novartis approved to treat periodic fever syndromes and systemic juvenile idiopathic arthritis under the trade name Ilaris. It also is being evaluated as a potential treatment for lung cancer.

How Canakinumab works

Canakinumab is a selective, high-affinity, fully humanized monoclonal antibody that inhibits IL-1beta, an important cytokine or cell-signaling molecule that has been associated with chronic inflammation and inflammatory lung diseases and lung cancer.

Induction of IL-1beta increases the intensity of the inflammatory response and creates an inflammatory microenvironment, which makes the initiation and/or development of a tumor easier. Lung epithelial cells produce and secrete IL-1beta after exposure to chemicals and other environmental agents such as cigarette smoke, therefore inducing small cell lung cancer (SCLC).

Canakinumab works by blocking the action of IL-1beta for a period of time, inhibiting inflammation that is caused by its over-production.

Canakinumab in clinical trials

A Phase 3 study (NCT01327846) from Novartis called CANTOS on more than 10,000 participants with atherosclerosis who had had a heart attack and were free of previously diagnosed cancer and had high-sensitivity C-reactive protein (hsCRP) concentrations of 2 mg/L or greater in their blood, is ongoing. hsCRP blood levels assess the risk of developing coronary artery disease, a major cause of heart attack.

During the trial, participants are assigned to receive either one of three doses of canakinumab (50 mg, 150 mg, or 300 mg) or a placebo injected under the skin every three months. They are then followed up for cancer diagnosis, measuring IL-6 another cytokine produced by normal and cancer cells, which is implicated in cancer proliferation and progression.

The results so far showed that levels of hsCRP and IL-6 in the blood at the beginning of the study were higher among participants who were later diagnosed with lung cancer. During follow-up, canakinumab was associated with a reduction in the concentrations of hsCRP and IL-6 compared to placebo, with total cancer mortality being significantly lower in the participants treated with canakinumab. Moreover, participants treated with canakinumab developed lung cancer less frequently than the placebo group. These findings led the researchers to conclude that canakinumab may reduce the incidence of lung cancer and mortality associated with it. Novartis is now planning to submit these data for drug approval.

Other details

Canakinumab is given as a shot into the fatty part of the skin. The drug may increase the risk of serious infections because it lowers the ability of the immune system to fight infections. The most common side effects caused by canakinumab may include flu-like symptoms, nausea, vomiting and diarrhea, vertigo, weight gain, and injection site reactions.


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