Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2017

Nivolumab vs investigator’s choice (IC) for platinum-refractory recurrent or metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN; checkmate 141): Outcomes in first-line R/M patients and updated safety and efficacy (#215)

Maura L Gillison 1 , George Blumenschein, Jr 2 , Jerome Fayette 3 , Joel Guigay 4 , A Dimitrios Colevas 5 , Lisa Licitra 6 , Kevin J Harrington 7 , Stefan Kasper 8 , Everett E Vokes 9 , Caroline Even 10 , Francis Worden 11 , Nabil F Saba 12 , Lara Carmen Iglesias Docampo 13 , Robert Haddad 14 , Tamara Rordorf 15 , Naomi Kiyota 16 , Makoto Tahara 17 , Mark Lynch 18 , Justin Kopit 18 , Robert L Ferris 19 , Diana Nazemian-Pour 20
  1. The Ohio State University, Columbus, OH, USA
  2. MD Anderson Cancer Center, Houston, TX, USA
  3. Centre Leon Berard, Lyon, France
  4. Centre Antoine Lacassagne, FHU OncoAge, Nice, France
  5. Stanford University, Stanford, CA, USA
  6. Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Milan, Italy
  7. Royal Marsden NHS Foundation Trust/The Institute of Cancer Research, London, UK
  8. West German Cancer Center, University Hospital, Essen, Germany
  9. University of Chicago Medical Center, Chicago, IL, USA
  10. Gustave Roussy, Villejuif Cedex, France
  11. University of Michigan, Ann Arbor, MI, USA
  12. Winship Cancer Institute of Emory University, Atlanta, GA, USA
  13. Hospital Universitario 12 de Octubre, Madrid, Spain
  14. Dana-Farber/Harvard Cancer Center, Boston, MA, USA
  15. Universitätsspital Zurich, Zurich, Switzerland
  16. Kobe University Hospital, Kobe, Japan
  17. National Cancer Center Hospital East, Kashiwa, Japan
  18. Bristol-Myers Squibb, Princeton, NJ, USA
  19. University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA, USA
  20. Bristol-Myers Squibb, Mulgrave, VIC, Australia


In the phase 3 CheckMate 141 trial, nivolumab demonstrated superior overall survival (OS) and better tolerability in patients with R/M SCCHN vs IC. Patients with SCCHN progressing within 6 months of platinum in the primary setting have dismal prognosis. We report on patients who were platinum refractory in the primary setting, and updated results overall.


Patients (N=361) with platinum-refractory R/M SCCHN were randomized 2:1 to nivolumab 3mg/kg Q2W or weekly IC (methotrexate/docetaxel/cetuximab). Primary endpoint was OS estimated by Kaplan-Meier. Cox proportional hazards models were used to estimate HRs and CIs. Additional endpoints: objective response rate (ORR), safety. Outcomes were analyzed overall and post-hoc in patients who were platinum-refractory in the primary setting (received nivolumab/IC as first-line R/M therapy).


Characteristics of patients who received nivolumab (n=52) or IC (n=26) as first-line R/M therapy were similar to the overall population. Nivolumab significantly improved OS vs IC among first-line R/M patients (median [95%CI]: 7.7 months [3.1-13.8] vs 3.3 months [2.1-6.4]; HR [95%CI]=0.56 [0.33-0.95]); 12-month OS rate: 39.2% vs 15.4%; ORR 19.2% vs 11.5%. At 11.4-months minimum follow-up, updated results overall were similar to the initial analysis. Median OS (95%CI) was 7.7 months (5.7-8.8) for nivolumab vs 5.1 months (4.0-6.2) for IC; HR (95%CI)=0.71 (0.55-0.90); P=0.0048. For nivolumab vs IC, 18-month OS rate: 21.5% vs 8.3%; ORR: 13.3% vs 5.8%. Nivolumab doubled median duration of response (9.7 vs 4.0 months). Grade 3–4 treatment-related adverse event rates for nivolumab vs IC: 15.3% vs 36.0% (overall); 27.5% vs 32.0% (first-line R/M); no new deaths occurred due to study drug.


Nivolumab significantly improved OS and increased ORR vs IC in a first-line R/M subgroup, supporting its use as first-line therapy for patients with platinum-refractory R/M SCCHN. Nivolumab showed significant survival benefit and better tolerability vs IC in patients with platinum-refractory R/M SCCHN.