Last Updated on October 17, 2017 by Joseph Gut – thasso

March 24, 2017 –  Merkel Cell Carcinoma (MCC) is a rare and highly aggressive form of skin cancer, which, in most cases, is caused by the Merkel Cell Polyomavirus (MCV). So far, patients with diagnosed MCC did not have an approved treatment option. This has dramatically changed with the announcement by the American Food & Drug Administration (FDA) that it has just approved Avelumab (Bavencio) for the treatment of adults and children of 12 years and

older with metastatic Merkel Cell Carcinoma (MCC), including those patients who have not received prior chemotherapy.

According to the National Cancer Institute, approximately 1,600 people in the United States are diagnosed with MCC every year. While the majority of patients present with localized tumors that can be treated with surgical resection, approximately half of all patients will experience recurrence, and more than 30 percent will eventually develop metastatic disease. In patients with metastatic MCC, the cancer has spread beyond the skin into other parts of the body.

Avelumab (Bavencio) targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). By blocking these interactions, Avelumab (Bavencio) may help the body’s immune system attack cancer cells. T In recent years, the scientific community has made advances targeting the body’s immune system mechanisms for the treatment of various types of cancer, particularly in the field of checkpoint inhibition. These advancements have lead to new therapy options, even in rare forms of cancer where treatment options have been limited or non-existent before, and Avelumab (Bavencio) would be the newest example of these efforts.

The approval of Avelumab (Bavencio) was based on data from a single-arm trial of 88 patients with metastatic MCC who had been previously treated with at least one prior chemotherapy regimen. The trial measured the percentage of patients who experienced complete or partial shrinkage of their tumors (overall response rate) and, for patients with a response, the length of time the tumor was controlled (duration of response). Of the 88 patients who received Avelumab (Bavencio) in the trial, 33 percent experienced complete or partial shrinkage of their tumors. The response lasted for more than six months in 86 percent of responding patients and more than 12 months in 45 percent of responding patients.

Avelumab (Bavencio) comes with a complicated spectrum of adverse drug reactions, of which some have to be considered serious. Common side effects of Avelumab (Bavencio) include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite and swelling of the limbs (peripheral edema). The most common serious risks of Avelumab (Bavencio) are immune-mediated, where the body’s immune system attacks healthy cells or organs, such as the lungs (pneumonitis), liver (hepatitis), colon (colitis), hormone-producing glands (endocrinopathies) and kidneys (nephritis). In addition, there is a risk of serious infusion-related reactions. Patients who experience severe or life-threatening infusion-related reactions should stop using Avelumab (Bavencio). Women who are pregnant or breastfeeding should not take Avelumab (Bavencio) because it may cause harm to a developing fetus or a newborn baby.

Avelumab (Bavencio) received an Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm Avelumab (Bavencio)’s clinical benefit and the sponsor is currently conducting these studies. The FDA granted this application also Priority Review and Breakthrough Therapy designation. Bavencio also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

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