The European Commission (EC) has approved the first-ever immunotherapy for the rare and aggressive skin cancer metastatic merkel cell carcinoma (mMCC).
This morning, Merck KGaA and Pfizer announced that the EC granted marketing authorization in 28 countries of the European Union (EU) for Bavencio (avelumab) as a monotherapy for the treatment of adult patients with mMCC. The drug will also have marketing authorization in Norway, Liechtenstein and Iceland.
Bavencio was approved by the U.S. Food and Drug Administration
(FDA) in March, and in July, the European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval
of the therapy.
mMCC is a rare oncological disease in which malignant cells form in the top layers of the skin and rapidly spread to other areas of the body. The disease most frequently begins in spots that are likely to be exposed to the sun, like the head and neck.
Before the condition progresses into metastatic disease, most MCC patients present with localized tumors that can be treated with surgical resection. An estimated 2,500 people in Europe are diagnosed with MCC annually, and most will experience recurrence. Between 5-12% all European MCC patients eventually develop mMCC.
"The EC's decision is significant for Bavencio and, more importantly, for European patients living with this very challenging skin cancer," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany in a press release
Today’s approval is based on data from JAVELIN Merkel 200, a 2-part international, multicenter, single-arm, open-label Phase 2 study. In the study, 127 total patients were enrolled and treated with Bavencio 10mg/kg as an intravenous infusion over 60 minutes every 2 weeks. Dosages were administered until disease progression or unacceptable toxicity, and overall efficacy and safety were demonstrated throughout.
In the first part of the study, 88 patients with mMCC were enrolled and an objective response rate of 33% was observed, with 11% of patients experiencing a complete response and 22% of patients experiencing a partial response. In the second part of the study, 39 metastatic treatment-naïve mMCC patients showed an objective response rate of 62%, with 14% of patients experiencing a complete response and 48% of patients experiencing a partial response.
"This European approval further establishes our continued momentum, building on the accelerated approvals Bavencio received in the US earlier this year," said Liz Barrett, Global President, Pfizer Oncology. "Importantly, we are now one step closer to our goal of making Bavencio available to patients around the world."
Dirk Schadendorf, MD, Director of Dermatology, University Hospital Essen, Germany said: "Merkel cell carcinoma is a particularly aggressive form of skin cancer with very poor outcomes, especially for those with metastatic disease," said. "This approval is a meaningful development for patients and their families suffering from this devastating disease."
For more from the EC, including designations and approvals, follow Rare Disease Report