Aims: The phase III trials CheckMate 017 (NCT01642004) and CheckMate 057 (NCT01673867) demonstrated improved OS with nivolumab (anti-programmed death-1 [PD-1] antibody) vs docetaxel as treatment for advanced previously treated squamous and non- squamous NSCLC, respectively. Nivolumab approval in these indications was based on these studies. Updated results with a minimum follow-up of 2 years are reported.
Methods: Patients received nivolumab 3 mg/kg Q2W or docetaxel 75 mg/m2 Q3W (1:1 randomization) until progression or discontinuation. Primary study objective was OS; additional objectives included investigator-assessed ORR, PFS, efficacy by PD ligand 1 (PD-L1) expression, and safety.
Results: With ≥2 year of follow-up, 8% and 9% of patients remained on nivolumab in CheckMate 017 and 057, respectively, vs 0 patients on docetaxel. In both studies, nivolumab vs docetaxel had higher 2-year OS rates (23% vs 8%; 29% vs 16%), PFS rates (16% vs not calculable; 12% vs 1%), and ORRs (20% vs 9%; 19% vs 12%). Median response duration was ≥3 times longer with nivolumab (25.2 and 17.2 mo) vs docetaxel (8.4 and 5.6 mo), with nivolumab responses lasting up to 30.4 and 33.7+ months. Responses were ongoing in 37% and 34% of nivolumab responders vs 0 docetaxel responders. In CheckMate 057, complete responses (n=4; 1%) were observed across PD-L1 expression levels. Grade 3−4 treatement-related adverse event rates for nivolumab vs docetaxel were 8% vs 56% in CheckMate 017 and 11% vs 54% in CheckMate 057, despite longer mean treatment durations with nivolumab vs docetaxel (7.5 vs 2.5 mo; 7.0 vs 3.3 mo).
Conclusions: With ≥2 year of follow-up, nivolumab continued to demonstrate OS benefit and high rates of durable response vs docetaxel in advanced NSCLC. Only nivolumab-treated patients had treatment ongoing and responses lasting >2 years. Nivolumab safety profile remained favorable vs docetaxel, with no new safety concerns identified.
Reused with permission from the European Society for Medical Oncology (ESMO). This abstract was accepted at the ESMO 2016 Annual Meeting. All rights reserved. The clinical trials and abstract were sponsored by Bristol-Myers Squibb.