Baseline Serum Cytokines May Be Associated With Nivolumab OS Benefit

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.

Reference

1. 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.