Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced Non-Small Cell Lung Cancer: 2-Year Follow-Up From a Randomized, Open-Label, Phase 3 Study (CheckMate 078)

Abstract Background In the phase 3 CheckMate 078 study, nivolumab showed significant overall survival (OS) benefit and superior tolerability versus docetaxel in a predominantly Chinese patient population with non-small cell lung cancer (NSCLC). However, data on long-term outcomes with immunotherapy in Asian patients are limited. We report 2-year efficacy and safety data. Methods Patients with advanced/metastatic NSCLC and disease progression after platinum-doublet chemotherapy were randomized 2:1 to nivolumab (3 mg/kg every 2 weeks; n = 338) or docetaxel (75 mg/m2 every 3 weeks; n = 166) until progression, unacceptable toxicity, or other protocol-defined reasons. The primary endpoint was OS; secondary endpoints included progression-free survival, objective response rate, and safety. Results After 25.9 months minimum follow-up, 21 patients (6%) remained on nivolumab versus 0 on docetaxel. Median OS was 11.9 months with nivolumab versus 9.5 months with docetaxel (HR: 0.75; 95% CI: 0.61–0.93); 2-year OS rates were 28% versus 18% respectively. Survival benefits were observed across a variety of predefined subgroups. At 2 years, 39% and 0% of responders had ongoing responses with nivolumab and docetaxel, respectively. Grade 3–4 treatment-related adverse events occurred in 12% of patients with nivolumab versus 47% with docetaxel, leading to discontinuation in 4% and 5% of patients, respectively. No new treatment-related deaths occurred. Conclusion At 2 years, nivolumab maintained a favorable safety profile and continued to demonstrate superior OS versus docetaxel in this predominantly Chinese patient population with previously treated NSCLC. These data are consistent with long-term outcomes from the global CheckMate 017/057 studies.