Poster Presentation Joint 2016 COSA and ANZBCTG Annual Scientific Meeting

Long-term Outcomes With Nivolumab vs Docetaxel in Patients With Advanced NSCLC: CheckMate 017 and CheckMate 057 2-year Update (#210)

Fabrice Barlesi 1 , Martin Steins 2 , Leora Horn 3 , Neal Ready 4 , Enriqueta Felip 5 , Hossein Borghaei 6 , David R. Spigel 7 , Oscar Arrieta 8 , Scott Antonia 9 , Jérome Fayette 10 , Naiyer Rizvi 11 , Lucio Crinò 11 , Martin Reck 12 , Wilfried EE Eberhardt 13 , Matthew Hellman 14 , William J Geese 11 , Ang Li 15 , Diane Healey 15 , Julie Brahmer 16 , Luis Paz-Ares 17
  1. Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille, Marseille, France
  2. Thoraxklinik-Heidelberg GmbH, Heidelberg, Germany
  3. Vanderbilt-Ingram Cancer Center, Nashville, TN, USA
  4. Duke University Medical Centre, Durham, NC, USA
  5. Hospital Universitari Vall d’Hebron , Barcelona, Spain
  6. Fox Chase Cancer Centre, Philadelphia, PA, USA
  7. Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN, USA
  8. Instituto Nacional de Cancerología, Mexico City, Mexico
  9. H. Lee Moffitt Cancer Centre & Research Institute, Tampa, FL, USA
  10. Léon Bérard, Lyon, France
  11. Memorial Sloan-Kettering Cancer Centre, New York, NY, USA
  12. Ospedale di Perugia, Perugia, Italy
  13. LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL) , Grosshansdorf, Germany
  14. University Hospital Essen, West German Cancer Center, University Duisburg-Essen , Ruhrlandklinik, Germany
  15. Bristol-Myers Squibb, Princeton, NJ, USA
  16. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA
  17. Hospital Universitario Doce de Octubre & CNIO, Madrid, Spain

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.