Previously treated patients with advanced squamous and nonsquamous non-small cell lung cancer (NSCLC) experience long-term clinical benefit and a favorable safety profile with nivolumab compared with docetaxel, according to a study published in The Journal of Clinical Oncology.
In the previously conducted phase 3 CheckMate 017 and CheckMate 057 studies, results showed that nivolumab provided superior overall survival (OS) compared with docetaxel. Researchers randomized 272 patients with advanced squamous NSCLC and 582 patients with advanced nonsquamous NSCLC to receive nivolumab 3 mg/kg every 2 weeks or docetaxel 75 mg/m2 every 3 weeks. Eligible patients had progressed despite previous treatment with platinum-based chemotherapy.
The minimum follow-up time for this long term analysis was approximately 2 years.
Two-year OS rates in patients with squamous NSCLC treated with nivolumab vs docetaxel were 23% (95% CI, 16%-30%) vs 8% (95% CI, 4%-13%), respectively. Patients with nonsquamous NSCLC treated with nivolumab had 2-year OS rates of 29% (95%, 24%-34%) compared with 16% (95% CI, 12%-20%) in patients treated with docetaxel. The OS rates were comparable to data previously reported from the studies.
Patients treated with nivolumab also achieved durable responses to therapy; 37% of confirmed responders with squamous NSCLC and 34% of confirmed responders with nonsquamous NSCLC maintained responses at the 2-year follow up. None of the patients in the docetaxel treatment arms maintained an ongoing response.
The nivolumab arms had a superior relative reduction in the risk of death of 28% (hazard ratio [HR], 0.72; 95% CI, 0.62-0.84) compared with the docetaxel arms.
Patients receiving nivolumab also experienced a superior toxicity profile compared to docetaxel with all-grade adverse event (AE) rates of 68% and 88%, respectively, and grade 3 to 4 AE rates of 10% and 55%, respectively.
The updated analyses of these phase 3 studies demonstrate that nivolumab provides long-term clinical benefit compared with docetaxel. The authors concluded that the “data support nivolumab as a standard-of-care treatment option in this broad patient population.”
Horn L, Spigel DR, Vokes EE, et al. Nivolumab versus docetaxel in previously treated patients with advanced non-small-cell lung cancer: two-year outcomes from two randomized, open-label, phase III trials (CheckMate 017 and CheckMate 057) [published online October 12, 2017]. J Clin Oncol. doi: 10.1200/JCO.2017.74.3062