Merck KGaA and Pfizer received marketing authorization from the European Commission for BAVENCIO (avelumab) as a monotherapy for the treatment of metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. BAVENCIO is expected to become commercially available within a few months, with initial launches in Germany and UK expected in October 2017.

Approximately 2,500 Europeans are affected by MCC each year, with metastatic disease diagnosed in 5-12% of patients. Fewer than 20% of patients with metastatic MCC survive beyond 5 years. 
The approval is based on data from JAVELIN Merkel 200, an international, multicenter Phase II study demonstrating an objective response rate of 33%, with 11% of patients experiencing a complete response and 22% of patients experiencing a partial response. A second part of the study included 39 patients with histologically confirmed mMCC who were treatment-naïve to systemic therapy in the metastatic setting. The objective response rate was 62%, with 14% of patients experiencing a complete response (CR) and 48% of patients experiencing a partial response (PR). Sixty-seven percent of patients experienced a progression-free survival (PFS) rate of 3 months.

“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 R&D, Merck KGaA. “Our alliance with Pfizer continues to demonstrate the power of working together, and we are grateful to everyone who has helped to bring the first and only approved immunotherapy for mMCC to European patients.”

“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.”