In Brief: Avelumab (Bavencio) for Metastatic Merkel Cell Carcinoma (online only)

Date: July 17, 2017 Issue #:  1525Summary:  The FDA has approved the fully-human programmed death ligand 1 (PD-L1) blocking antibody avelumab (Bavencio– EMD Serono/Pfizer) for treatment of metastatic Merkel cell carcinoma (MCC) in patients ≥12 years old. Avelumab is the first drug to be approved in the US for this rare skin cancer. About 1600 people in the US, most commonly older adults (mean age at presentation is 75 years), are diagnosed eac h year with MCC. Most of these patients can be treated with surgical resection, but ~50% will have a recurrence and>30% will eventually have metastatic disease. Median progression-free survival in patients with metastatic disease has been about 3 months with chemotherapy. MCC tumors, which often express PD-L1, have been treated offlabel with the PD-1 inhibitors pembrolizumab(Keytruda)1 and nivolumab(Opdivo).2In an ongoing single-arm trial (JAVELIN Merkel 200), 88 patients with metastatic MCC (58 with PD-L1 positive tumors, 16 PD-L1 negative, 14 not assessable) who were previously treated with at least one chemotherapy regimen received at least one dose of avelumab; 75% of patients were 65 years or older. An objective response occurred in 28 patients (32%); 8 patients had a complete response. Tumor PD-L1 expression did not affect response rates. The duration of response was ≥6 months in 92% of responders.3The most common adverse effects of avelumab in clinical trials were fatigue (50%), ...
Source: The Medical Letter - Category: Drugs & Pharmacology Authors: Tags: avelumab Bavencio Keytruda nivolumab Opdivo pembrolizumab skin cancer Source Type: research