On March 23, 2017, the FDA accelerated the approval of avelumab (Bavencio; EMD Serono/Pfizer), PD-L1–blocking antibody, for the treatment of adults and pediatric patients aged ≥12 years with metastatic Merkel-cell carcinoma. This is the first nonchemotherapy drug approved by the FDA for this rare type of cancer.
“While skin cancer is one of the most common cancers, patients with a rare form called Merkel-cell cancer have not had an approved treatment option until now,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “The scientific community continues to make advances targeting the body’s immune system mechanisms for the treatment of various types of cancer. These advancements are leading to new therapies—even in rare forms of cancer where treatment options are limited or non-existent.”
The approval of avelumab was based on the efficacy and safety results from the JAVELIN Merkel 200 clinical trial, an open-label, single-arm, multicenter study involving 88 patients with metastatic Merkel-cell carcinoma that progressed during or after chemotherapy. Patients received Bavencio 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
The major efficacy outcome measures were the overall response rate and the duration of response. The overall response rate was 33% (95% confidence interval, 23.3-43.8), and the duration of response ranged from 2.8 months to approximately 23.3 months.
Of the 88 patients who were enrolled in the JAVELIN Merkel 200 clinical trial, the most common (≥20%) all-grade adverse reactions were fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, and peripheral edema. Serious adverse reactions that occurred in more than 1 patient included acute kidney injury, anemia, abdominal pain, ileus, asthenia, and cellulitis.
Avelumab 10 mg/kg is administered as an intravenous infusion every 2 weeks.