Select serum cytokines may be associated with survival benefit in patients with advanced refractory squamous non-small cell lung cancer (NSCLC), according to a study presented at the European Lung Cancer Conference (ELCC) 2016.1
Because patients with advanced platinum-refractory squamous NSCLC have limited treatment options, researchers designed the CheckMate 063 and CheckMate 017 trials to evaluate the efficacy and safety of nivolumab, a fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody.
In CheckMate 063, 117 patients received nivolumab 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity. The 272 participants of CheckMate 017 were randomly assigned 1:1 to receive nivolumab or docetaxel 75 mg/m2 every 3 weeks until progressive disease or discontinuation.
Results showed that at a median follow-up of 2 years, median overall survival was 8.1 months (95% CI, 6.1 – 10.9) with nivolumab in CheckMate 063, and was 9.2 months (95% CI, 7.33 – 12.62) with nivolumab compared with 6.0 months (95% CI, 5.29 – 7.39) with docetaxel.
Objective response rate was 15% (95% CI, 9 – 22) in CheckMate 063, and was 20% (95% CI, 14 – 28) and 9% (95% CI, 5 – 15) for nivolumab and docetaxel, respectively, in CheckMate 017.
In regard to safety, 17% and 8% of patients in CheckMate 063 and CheckMate 017, respectively, experienced grade 3 or 4 treatment-related adverse events. Five percent of nivolumab-treated patients in CheckMate 017 and 12% of those in CheckMate 063 discontinued therapy due to treatment-related toxicities.
Researchers also conducted a multivariate exploratory analysis of baseline serum cytokines in 222 nivolumab-treated patients from both studies. The analysis demonstrated that patients with a high SQ-cytoscore had a median overall survival of 15.6 months vs 5.3 months among the 120 patients with a low SQ-cytoscore (HR, 0.48; 95% CI, 0.36 – 0.64; P < .0001).
A prospective study is necessary to confirm the findings of these preliminary results.
- Lena H, Rizvi NA, Wolf J, et al. Nivolumab in patients (pts) with advanced refractory squamous (SQ) non-small cell lung cancer (NSCLC): 2-year follow-up from CheckMate 063 and exploratory cytokine profiling analyses. Oral presentation at: European Lung Cancer Conference 2016; April 13-16, 2016; Geneva, Switzerland.