In a nutshell
This study compared the efficacy of antitumor drugs nivolumab (Opdivo) and docetaxel (Taxotere) in the treatment of advanced non-small-cell lung cancer (NSCLC). The study concluded that nivolumab has better activity in advanced nonsquamous NSCLC which express the ligand PD-L1 and has a safer toxicity profile overall than docetaxel.
Some background
NSCLC tumors can express the ligand PD-L1. This reduces the activity of specific immune cells known as T-cells. In theory, using inhibitors to block the PD-1 receptor on T cells could restore the immune system’s anticancer activity. Docetaxel is currently used as second line treatment for advanced NSCLC however causes a high number of adverse side effects. Therefore, using nivolumab may be better than docetaxel for advanced NSCLC.
Methods & findings
This study included 555 patients with stage IIIb/IV advanced nonsquamous NSCLC. Patients were randomised into two groups; group 1 included 287 patients treated with nivolumab while group 2 included 268 patients treated with docetaxel. Patients were than examined after a minimum of 1 year and again after 18 months for overall survival and objective response rate (ORR, patients with tumors that decrease by at least 50%).
Overall survival (OS) rate was significantly better for patients treated with nivolumab than docetaxel. OS rate for nivolumab was 51% after 1 year and 39% after 18 months, while OS rate for docetaxel was 39% after 1 year and 23% after 18 months. The objective response rate for group 1 was 19% while group 2 was 12%.
Adverse side effects of any grade were lower in group 1 (69%) than group 2 (88%). For grade 3 or 4 side effects, group 1 had 10% while group 2 had 54%. 1 patient in each group died from treatment related side effects.
Overall, 78% of patients had PD-L1 expression. The differences seen in OS rate and ORR were only significant in these patients. While there were no significant differences between nivoumab and docetaxel in patients without PD-L1 expression, the safety profile is better for nivolumab.
The bottom line
Nivolumab has better activity in patients with advanced non squamous NSCLC that express PD-L1 and has a better safety profile than docetaxel.
The fine print
This study was funded by manufacturers of nivolumab.
What’s next?
Speak to your doctor about nivolumab if you have advanced nonsquamous NSCLC with PD-L1 expression.
Published By :
The New England Journal of Medicine
Date :
Sep 27, 2015
