Five-Year Outcomes From the Randomized, Phase III Trials: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer

Introduction

Immunotherapy has revolutionized the treatment of advanced non–small-cell lung cancer (NSCLC). Nivolumab, a PD-1 inhibitor, has shown significant improvements in overall survival (OS) and progression-free survival (PFS) compared to docetaxel in patients with previously treated, advanced squamous and nonsquamous NSCLC.

Methods

Patients with advanced NSCLC, ECOG PS ≤ 1, and progression during or after first-line platinum-based chemotherapy were randomly assigned to receive nivolumab or docetaxel. The primary endpoint was OS, with secondary endpoints including PFS and safety.

Results

After a minimum follow-up of 64.2 and 64.5 months for CheckMate 017 and 057, respectively, nivolumab-treated patients showed a 13.4% 5-year OS rate compared to 2.6% for docetaxel. The 5-year PFS rates were 8.0% for nivolumab and 0% for docetaxel. Nivolumab maintained a favorable safety profile, with no new safety signals identified.

Conclusion

Nivolumab continues to demonstrate a significant survival benefit over docetaxel in patients with previously treated, advanced NSCLC, with a five-fold increase in OS rate. These findings represent an important advancement in the treatment of lung cancer, offering long-term survival benefits and durable responses with a tolerable safety profile.

Context

This study provides the first report of 5-year outcomes from randomized phase III trials of a PD-1 inhibitor in previously treated, advanced NSCLC, highlighting the potential for nivolumab to improve outcomes in a diverse patient population. The data underscore the importance of nivolumab as a standard of care for patients who have progressed on or after platinum-based chemotherapy.