Avelumab in Progressive or Treatment-Resistant NSCLC
The human immunoglobulin G monoclonal antibody targeting programmed cell death ligand 1 (PD-L1) avelumab appears to be safe and demonstrates antitumor activity in patients with progressive or treatment-related non–small cell lung cancer (NSCLC), according to a dose-expansion, open-label, multicenter, phase I study published in The Lancet Oncology. Avelumab has been approved by the U.S. Food and Drug Administration for the treatment of Merkel cell carcinoma.
Between September 2013 and June 2014, 184 patients with advanced platinum-treated NSCLC were enrolled in this cohort study, with a median follow-up of 8.8 months. The most common treatment-related adverse events of any grade were fatigue (25%), infusion-related reaction (21%), and nausea (13%). Grade 3 or worse treatment-related adverse events occurred in 13% of patients.
A confirmed objective response was achieved in 12% of patients (22 of 184), including 1 complete response and 21 partial responses. A total of 70 patients (38%) had stable disease. Disease control was achieved in half of patients overall.
The investigators consider these early findings to provide a rationale for further studies of avelumab in this disease setting.