Oncology Central

Immunotherapy drug becomes the first US FDA-approved systemic therapy for merkel cell carcinoma


A study published recently in The Lancet Oncology, has led to the approval of the checkpoint inhibitor avelumab for the treatment of merkel cell carcinoma patients (MMC). The Phase II trial termed JAVELIN Merkel 200, which led to the approval, included 88 patients who had metastatic MCC that had recurred despite at least one round of chemotherapy or other treatments used off-label.

Merkel cell carcinoma is a rare and aggressive form of skin cancer, which despite being 35 times less common than melanoma, is approximately three-times more likely to be fatal. Up until recently, no systemic therapies had been approved by the US FDA  for MCC and no therapies had been approved following metastasis of the cancer.

An MCC patient, Tom Judd from Portland (OR, US), experienced first-hand what is like to be diagnosed with a lethal cancer after being diagnosed in 2013. Soon after his diagnosis, the cancer metastasized from a small lesion on his nose throughout his body, critically interfering with his organ function.

By early 2015, the cancer had almost taken his life, despite a treatment course of surgery, radiotherapy and chemotherapy. Judd then enrolled into a clinical trial for a new immunotherapy drug where he received his first of several infusions of the checkpoint inhibitor, avelumab. Six weeks after the initial infusion, over one-third of the cancer was gone, as of today more than 90% of the tumor mass has disappeared.

As a result of the data from the trial, avelumab is now the first systemic therapy that has received FDA approval for MCC and the first approved treatment for any kind for metastatic MCC.

Paul Nghiem from the University of Washington (WA, USA) senior investigator of the trial and and senior author on the article that preceded the drugs approval stated that the approval as both a first- and second-line therapy “is a really big deal”.

The foundational work from Nghiem and his team on the role of immune cells in MCC pioneered the way for immunotherapy trials in the cancer, including  a pembrolizumab trial he leads, an immunotherapeutic with a similar method of action that changed the field overnight once its results were published.


Fred Hutch news article: www.fredhutch.org/en/news/center-news/2017/03/immunotherapy-fda-approved-merkel-cell-carcinoma.html




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