Extended Follow-Up Shows Benefit of Nivolumab in Advanced NSCLC

Nivolumab offers extended overall survival (OS) benefit over docetaxel in patients with advanced non–small-cell lung cancer (NSCLC), according to an analysis of two studies with more than 3 years of follow-up. The OS benefit included patients with liver metastases.

“Despite recent advances in NSCLC, patients with metastatic disease generally continue to have a poor prognosis,” wrote study authors led by Everett E. Vokes, MD, of the University of Chicago Medicine. It was previously reported that the CheckMate 017 and 057 studies showed a survival benefit with nivolumab, but long-term data have previously been limited. This analysis extended the CheckMate 017 and 057 studies out to a minimum of 40.3 months of follow-up.

The study included a total of 854 patients randomized to receive either nivolumab or docetaxel across the two studies. At 3 years, among the nivolumab patients, 5% of those with squamous NSCLC and 7% of those with non-squamous NSCLC remained on treatment. No patients treated with docetaxel remained on treatment at that point. The results of the study were published in Annals of Oncology.

OS was longer with nivolumab, at a median of 11.1 months compared with 8.1 months with docetaxel, for a hazard ratio (HR) of 0.70 (95% CI, 0.61–0.81). The 3-year OS rate was 17% with nivolumab, compared with 8% with docetaxel. The extended OS was seen with nivolumab regardless of histology. Of the 34 docetaxel patients who survived to 3 years, 74% received subsequent immunotherapy.

Progression-free survival rates favored nivolumab at 1, 2, and 3 years. The estimated 3-year progression-free survival rate was 10% with nivolumab and < 1% with docetaxel. Response rates were also higher with the immunotherapy than with docetaxel, and the median duration of response was 23.8 months with nivolumab and 5.6 months with docetaxel.

There were 193 patients (23%) who had liver metastases at baseline. In these patients, there was again an OS benefit with nivolumab, with an HR of 0.68 (95% CI, 0.50–0.91). The 3-year OS rate was 8% with nivolumab and 2% with docetaxel in patients with liver metastases.

Between years 2 and 3 of minimum follow-up, three new grade 3/4 adverse events were reported, including arthralgia, joint effusion, and interstitial lung disease. The safety profile of nivolumab was generally consistent with previous reports, and the safety of the drug specifically in patients with liver metastases was similar to that seen in the general population.

“These updated analyses from CheckMate 017 and CheckMate 057 demonstrate long-term clinical benefit with nivolumab in previously treated patients with advanced squamous and non-squamous NSCLC, including those with liver metastases,” the authors concluded.