Avelumab

In a phase II trial (JAVELIN Merkel 200 [NCT02155647]), 88 patients with metastatic MCC received avelumab (10 mg/kg intravenously [IV] every 2 weeks). These patients had previously received chemotherapy.[37] Based on the results of this study, the U.S. Food and Drug Administration (FDA) approved avelumab in 2017 for the treatment of patients with metastatic MCC, regardless of previous chemotherapy administration.[37-39]

In a phase II trial (JAVELIN Merkel 200 [NCT02155647]), 88 patients with metastatic MCC received avelumab (10 mg/kg intravenously [IV] every 2 weeks). These patients had previously received chemotherapy.[37] Based on the results of this study, the U.S. Food and Drug Administration (FDA) approved avelumab in 2017 for the treatment of patients with metastatic MCC, regardless of previous chemotherapy administration.[37-39]

The objective response rate was 33%, and 11% of patients had a complete response. The median time to response was 6.1 weeks and was irrespective of MCPyV or PD-L1 status. More importantly, responses were durable, with 74% lasting at least 1 year. The median OS was 12.6 months, more than twice the historical median with second-line chemotherapy.

Avelumab was also studied in the first-line setting in a single-arm phase II trial of 116 patients.[40]

Avelumab was also studied in the first-line setting in a single-arm phase II trial of 116 patients.[40]

After a median follow-up of 21.2 months, 30.2% (95% confidence interval [CI], 22.0%–39.4%) of patients had a durable response (>6 months). The objective response rate was 39.7%, and the median OS was 20.3 months (95% CI, 12.4–not estimable).[40][Level of evidence C3]

Avelumab was also studied in the first-line setting in a single-arm phase II trial of 116 patients.[40]

Exploratory analyses found that responses were higher in patients with PD-L1 expression and in those negative for MCPyV.