Breakthrough Treatment for Merkel Cell Carcinoma

The breakthrough PD-L1 inhibitor Avelumab (Bavencio) has been approved by the Japanese Ministry of Health, Labor and Welfare for use in Japanese patients with metastatic Merkel cell carcinoma. It is the first curative treatment for unresectable Merkel cell carcinoma and first anti-PD-L1 agent to be approved in Asia, after receiving its first global approval in the US in March and in Europe in September.

Dr Naoya Yamazaki, chief of the Department of Dermatologic Oncology at Japan’s National Cancer Centre Hospital, said that Merkel cell carcinoma progresses quickly and has a poor prognosis for so many, so the drug’s approval “is a huge step forward for people impacted by this destructive disease.” Previously, the only treatment for this type of skin cancer was chemotherapy.

Merkel cell carcinoma, also known as trabecular cancer or neuroendocrine carcinoma of the skin, is a rare disease in Japan and is estimated to affect fewer than 100 patients. It is an aggressive disease in which cancer cells form in the top layer of the skin, close to nerve endings. It typically begins in areas most often exposed to the sun, such as the head, neck and arms. While it is 40 times less common than melanoma, it is three times more lethal.

Avelumab’s approval in Japan, the US and Europe was based on data from the phase 2 JAVELIN Merkel 200 study, in which the objective response rate with avelumab was 33 percent. This included a complete response rate of 11.4 percent and a partial response rate of 21.6 percent. The duration of response was at least six months in 93 percent of the responding patients, with 71 percent having a response duration of over a year. The duration ranged from three to 25 months.

Median progression-free survival with avelumab was 2.7 months. The six-month rate was 40 percent. The average overall survival was 11.3 months and the six-month rate was 69 percent.

Avelumab is currently under phase 2 investigation in Australia and Switzerland.

Click here to read about the latest research in the treatment of actinic keratosis.


Harris, J. (September 27, 2017.) Avelumab Approved in Japan for Merkel Cell Carcinoma. OncLive.

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