Nivolumab is the first immunotherapy medicine licensed in the European Union for the treatment of squamous-cell non-small cell lung cancer (NSCLC). Based on the findings of the CheckMate 017 trial, nivolumab received market authorisation for previously treated patients with squamous NSCLC in July 2015.
This open-label phase III study compared nivolumab with docetaxel in a total of 272 patients with squamous-cell NSCLC who had previously been treated with one platinum-containing regimen Median. Overall survival (the primary outcome of this phase III trial) was increased by 3.2 months in the nivolumab group in comparison to the docetaxel group, resulting in a reduction of risk of death by 41%. With 38%, the risk of progression or death was also statistically lower, leading to a gain in median progression-free survival by 0.7 months. Duration of response was not yet reached in the nivolumab group and was 8.4 months in the docetaxel group. Response rates also favoured the PD-L1 inhibitor (20% vs 9%), with the majority being partial responses (19% vs 9%).
In terms of safety outcomes, treatment-related adverse events (AEs) were less frequent in the nivolumab group than in the chemotherapy group. Any-grade AEs occurred in 58% in the nivolumab group in comparison to 86% in the docetaxel group, and grade 3 or 4 AEs in 7% and 55% respectively.
Overall, improved outcomes in all assessed endpoints were demonstrated in the CheckMate 017 trial, with fewer AEs in comparison to standard second-line chemotherapy. Nonetheless, high costs are incurred, data for patient-reported outcomes have not been published yet and long-term adverse effects of immune therapies are unknown.