Long-term data comparing outcomes with immune checkpoint inhibitors versus chemotherapy in NSCLC are limited. The phase 3 trials CheckMate 017 and 057 demonstrated improved overall survival (OS) and objective response rates (ORR), and a favorable safety profile, with the anti-programmed death (PD)-1 antibody nivolumab versus docetaxel in patients with previously treated advanced squamous and non-squamous NSCLC, respectively. Updated results based on a minimum follow-up of 3 years are reported.
Patients were randomized 1:1 to receive nivolumab 3 mg/kg Q2W or docetaxel 75 mg/m2 Q3W until progression or discontinuation. After completion of the primary analyses, patients who ended treatment with docetaxel could cross over to receive nivolumab. The primary endpoint of each study was OS; other endpoints were ORR, progression-free survival, and efficacy by PD ligand 1 (PD-L1) expression.
After a minimum follow-up of 36.6 months in each study (February 2017 database locks), 6% of all 427 patients randomized to the 2 nivolumab arms remained on treatment; no patient remained on docetaxel. Nivolumab continued to show an OS benefit versus docetaxel, with HR of 0.62 (95% CI: 0.48, 0.80) in CheckMate 017 and 0.74 (95% CI: 0.62, 0.89) in CheckMate 057, and 3-year OS rates of 16% versus 6% in CheckMate 017 and 18% versus 9% in CheckMate 057. Similar to prior reports, an OS benefit was observed in squamous NSCLC regardless of PD-L1 expression, and in non-squamous NSCLC was enhanced at higher PD-L1 expression levels. In the combined nivolumab arms, 71 (17%) patients had OS ≥3 years. Additional 3-year data across trial endpoints will be presented.
With ≥3 years of follow-up from 2 randomized phase 3 studies, nivolumab continued to demonstrate an OS benefit versus docetaxel in patients with advanced squamous or non-squamous NSCLC. Overall, 3-year survival was achieved in 17% of nivolumab-treated patients.