First-Line Avelumab for Metastatic Merkel Cell Carcinoma
Posted: Tuesday, July 10, 2018
In patients with metastatic Merkel cell carcinoma, an aggressive skin cancer associated with poor survival outcomes, treatment with first-line avelumab was associated with early responses, high response rates, and a manageable safety profile, according to the results of a preplanned interim analysis of the phase II JAVELIN Merkel 200 part B trial. These data were reported by Sandra D’Angelo, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues, in JAMA Oncology.
In the study, 39 patients with no prior systemic treatment for metastatic disease received avelumab at 10 mg/kg every 2 weeks until disease progression, unacceptable toxicity, or study withdrawal. Data were collected from April 2016 to March 2017, and enrollment is ongoing.
In the preplanned analysis, efficacy was assessed in 29 patients with at least 3 months of follow-up. Avelumab treatment resulted in a confirmed objective response rate of 62.1%, with complete responses in 4 patients. In responding patients, the duration of response has been at least 3 months in 93% and at least 6 months in 83%. Grade 3 treatment-related adverse events occurred in 20% of patients, with no treatment-related deaths.
“High rates of response to first-line avelumab therapy in patients with distant metastatic Merkel cell carcinoma build on previously reported antitumor activity after second-line or later treatment, and maturing progression-free survival data suggest that responses are durable,” the investigators reported. “These data further support avelumab’s approval in the United States and European Union and use as a standard-of-care treatment for metastatic Merkel cell carcinoma.”