Merck and Pfizer's joint skin cancer drug gets EU approval

Merck KGaA and Pfizer have announced that European authorisation of their jointly developed drug Bavencio (avelumab) as a monotherapy in the treatment of metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer.

The European Commission (EC)’s decision was based on the success of Bavencio in Phase 2 trials. In part A of the study, which tested the drug in 88 participants whose mMCC had progressed after at least one chemotherapy treatment, an objective response rate (ORR) of 33% was observed. This figure breaks down to 11% who experienced complete response and 22% who experienced partial response. Tumour response was found to be durable, with 93% of responses lasting at least six months and 71% lasting at least one year.

Part B evaluated the effects of Bavencio in 39 patients included 39 patients with histologically confirmed mMCC who were treatment-naïve to systemic therapy in the metastatic setting. In this group, ORR was found to be 62%, with 14% of patients experiencing a complete response and 48% of patients experiencing a partial response. Furthermore, 67% experienced a progression-free survival rate of 3 months.

Bavencio was previously awarded accelerated approval by the EC earlier this year, and was also granted marketing authorisation in Switzerland on 5 September.

"The EC's decision is significant for Bavencio and, more importantly, for European patients living with this very challenging skin cancer," said Luciano Rossetti, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck. "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."

Liz Barrett, Global President, Pfizer Oncology, added: "This European approval further establishes our continued momentum, building on the accelerated approvals Bavencio received in the US earlier this year. Importantly, we are now one step closer to our goal of making Bavencio available to patients around the world."