The European Commission (EC) has granted Bavencio (avelumab) marketing approval as the first immunotherapy to treat the aggressive skin cancer metastatic Merkel cell carcinoma in adults.
The decision will allow an introduction of Bavencio — developed jointly by Merck KGaA and Pfizer — in all 28 European Union member states, as well as Norway, Liechtenstein, and Iceland.
“The EC’s decision is significant for Bavencio and, more importantly, for European patients living with this very challenging skin cancer,” Luciano Rossetti, MD, executive vice president, Global Head of Research & Development at the biopharma business of Merck KGaA (EMD Serono in the U.S. and Canada), said in a press release.
“Merkel cell carcinoma is a particularly aggressive form of skin cancer with very poor outcomes, especially for those with metastatic disease. This approval is a meaningful development for patients and their families suffering from this devastating disease,” added Dirk Schadendorf, MD, director of Dermatology, University Hospital Essen in Germany.
The approval was based on data from the Phase 2 JAVELIN Merkel 200 trial (NCT02155647). Findings, published in the journal The Lancet Oncology, showed that 33 percent of 88 patients with metastatic Merkel cell carcinoma, who relapsed after at least one chemotherapy round, had responded to the treatment.
Among them, 11 percent had a complete tumor eradication. Researchers also reported that 93 percent of those who responded continued to respond for at least six months, and 71 percent had responses lasting at least a year. Some patients had responses lasting more than two years.
The study also included a group of patients who had not yet received treatment for their metastatic cancer. Among these 39 patients, the response rate was 62 percent, with 14 percent having a complete response. In this group, two-thirds had a progression-free survival of three months.
In addition, researchers have gathered safety data on Bavencio — a checkpoint inhibitor targeting PD-L1 — from clinical trials involving 1,738 patients with solid tumours. These studies included 88 patients with metastatic Merkel cell carcinoma and showed that the most common adverse effects of the treatment were fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight loss, and vomiting.
“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 [metastatic Merkel cell carcinoma] to European patients,” Rossetti said.
The U.S. Food and Drug Administration approved Bavencio through an accelerated approval program in March 2017.
“This European approval further establishes our continued momentum, building on the accelerated approvals Bavencio received in the U.S. 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.”
The companies stated that the treatment will become available in the Europe Union within the coming months, with Germany and the U.K. at the top of the launch list, where introduction is expected to start in October 2017.
