Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2017

Nivolumab vs Investigator’s Choice (IC) in patients with Recurrent or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN): efficacy and safety in checkMate 141 by Prior cetuximab use (#214)

Robert L Ferris 1 , Lisa Licitra 2 , Jerome Fayette 3 , Caroline Even 4 , George Blumenschein, Jr 5 , Kevin J Harrington 6 , Joel Guigay 7 , Everett E Vokes 8 , Nabil F Saba 9 , Robert Haddad 10 , Shanmugasundaram Ramkumar 11 , Jeffery Russell 12 , Peter Brossart 13 , Makoto Tahara 14 , Manish Monga 15 , Jin Zhu 15 , A Dimitrios Colevas 16 , Maura L Gillison 17 , Diana Nazemian-Pour 18
  1. University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA, USA
  2. Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Milan, Italy
  3. Centre Leon Berard, Lyon, France
  4. Gustave Roussy, Villejuif Cedex, France
  5. MD Anderson Cancer Center, Houston, TX, USA
  6. Royal Marsden NHS Foundation Trust/The Institute of Cancer Research, London, UK
  7. Centre Antoine Lacassagne, FHU OncoAge, Nice, France
  8. University of Chicago Medical Center, Chicago, IL, USA
  9. Winship Cancer Institute of Emory University, Atlanta, GA, USA
  10. Dana-Farber/Harvard Cancer Center, Boston, MA, USA
  11. University Hospital Southampton/NHS Foundation Trust, Southampton, UK
  12. Moffitt Cancer Center, Tampa, FL, USA
  13. University Hospital of Bonn, Bonn, Germany
  14. National Cancer Center Hospital East, Kashiwa, Japan
  15. Bristol-Myers Squibb, Princeton, NJ, USA
  16. Stanford University, Stanford, CA, USA
  17. The Ohio State University, Columbus, OH, USA
  18. Bristol-Myers Squibb, Mulgrave, VIC, Australia

Aims:

In CheckMate 141, nivolumab resulted in significantly prolonged overall survival (OS), favorable safety, and stable quality of life vs IC in patients with platinum-refractory R/M SCCHN. Cetuximab, a formal trial stratification factor, permits exploratory subgroup assessment. Outcomes by prior cetuximab are described.

Methods:

CheckMate 141 was a randomized, open-label, phase 3 trial (NCT02105636). Patients (N=361) with platinum-refractory R/M SCCHN were randomized 2:1 (stratified by prior cetuximab) to nivolumab 3mg/kg every 2 weeks or IC (methotrexate/docetaxel/cetuximab). Primary endpoint was OS; additional endpoints: progression-free survival (PFS), objective response rate (ORR), safety. Multivariate analysis explored influence of additional factors.

Results:

In the nivolumab and IC arms, respectively, 93 and 47 patients had no prior cetuximab use, and 147 and 74 received prior cetuximab. Median OS (95%CI) for nivolumab vs IC without: 8.1 (5.3-12.7) vs 4.7 (3.0-7.2) months (HR [95%CI]=0.55 [0.35-0.86]) and with prior cetuximab: 6.9 (4.9-8.8) vs 5.2 (4.1-6.8) months (HR [95%CI]=0.81 [0.57-1.15]). Median OS was longer for nivolumab vs IC in patients with tumor PD-L1 expression ≥1% regardless of prior cetuximab, and in patients with PD-L1 expression <1% without prior cetuximab. ORR for nivolumab vs IC was 17.2% vs 4.3% without and 10.9% vs 6.8% with prior cetuximab. ORR for nivolumab vs IC among PD-L1 ≥1% was 19.4% vs 0% without and 15.4% vs 2.5% with prior cetuximab. ORR for nivolumab vs IC among HPV+: 29.6% vs 0% without and 5.6% vs 5.6% with prior cetuximab. PFS was similar regardless of prior cetuximab. Grade 3–4 treatment-related adverse event rates for nivolumab vs IC: 11.7% vs 40.9% with; 15.4% vs 26.7% without prior cetuximab.

Conclusions:

OS and ORR improved with nivolumab vs IC regardless of prior cetuximab; magnitude of benefit was greater in patients without prior cetuximab exposure. These results support use of nivolumab for R/M SCCHN regardless of prior cetuximab.