Nivolumab (N), a fully human monoclonal antibody that is a PD-1 immune checkpoint inhibitor, has demonstrated efficacy in patients with previously treated advanced NSCLC. A report at ASCO 2014 presented data with N as first-line therapy in the first 20 chemotherapy-naïve patients with advanced NSCLC (Gettinger SN, et al. ASCO 2014. Abstract 8024). In an open-label uncontrolled study, patients with squamous or nonsquamous advanced NSCLC received N until disease progression or unacceptable toxicity. RECIST responses were evaluated overall and based on PD-L1 status. After at least 6 months of follow-up, the objective response rate was 30% (67% in PD-L1-positive patients and 0% in PD-L1-negative patients). Median progression-free survival was 29.6 weeks (not reached in PD-L1-positive patients and 23.1 weeks in PD-L1-negative patients). Treatment-related grade 3/4 adverse events with N included aspartate aminotransferase/alanine aminotransferase elevations, hyperglycemia, and rash. No pneumonitis of any grade was observed. These early data are promising, but further studies with N as first-line therapy in advanced NSCLC are needed. Moreover, it appears evident that PD-L1 status will need to be evaluated prior to using N in NSCLC patients, and this will add to the cost of this therapy.
