Poster Presentation COSA 2015 ASM

Efficacy and safety in key patient subgroups of nivolumab (NIVO) alone or combined with ipilimumab (IPI) versus IPI alone in treatment-naïve patients with advanced melanoma (MEL) (CheckMate 067) (#204)

James Larkin 1 , Vanna Chiarion-Sileni 2 , Rene Gonzalez 3 , Jean-Jacques Grob 4 , C. Lance Cowey 5 , Christopher D Lao 6 , John Wagstaff 7 , David Hogg 8 , Andrew Hill 9 , Matteo S Carlino 10 , Pascal Wolter 11 , Celeste Lebbé 12 , Jacob Schachter 13 , Luc Thomas 14 , Jessica C Hassal 15 , Paul Lorigan 16 , Dana Walker 17 , Joel Jiang 18 , F Stephen Hodi 19 , Jedd D Wolchok 20
  1. Royal Marsden Hospital, London, United Kingdom
  2. IOV-IRCCS, Melanoma Oncology Unit, Padova, Italy
  3. University of Colorado Cancer Center, Denver, CO, USA
  4. Aix-Marseille University, Hôpital de La Timone APHM, Marseille, France
  5. Baylor Charles A. Sammons Cancer Center, Dallas, TX, USA
  6. University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, USA
  7. South West Wales Cancer Institute and Swansea University College of Medicine, Swansea, Wales
  8. Princess Margaret Hospital, University of Toronto, Toronto, ON, Canada
  9. Tasman Oncology Research, Southport Gold Coast, Queensland, Australia
  10. Melanoma Institute Australia, and the University of Sydney , Sydney, NSW, Australia
  11. UZ Leuven, Leuven, Belgium
  12. Hôpital Saint-Louis University Paris Diderot, Paris, France
  13. Oncology Institute, Tel Hashomer, Israel
  14. Centre Hospitalier Lyon Sud, Pierre-Bénite, France
  15. German Cancer Research Centre University Hospital , Heidelberg, Germany
  16. The Christie NHS Foundation Trust, Manchester, United Kingdom
  17. Bristol-Myers Squibb, Princeton, NJ, USA
  18. Bristol-Myers Squibb, Hopewell, NJ, USA
  19. Dana-Farber Cancer Institute, Boston, MA, USA
  20. Memorial Sloan-Kettering Cancer Centre, New York, NY, USA

Aims: Phase III study CheckMate 067 reported improved progression-free survival (PFS) with NIVO + IPI vs IPI alone. Here, we report results of subgroup analyses in this trial.

Methods: Treatment-naïve MEL pts (N=945) were randomized 1:1:1 to receive NIVO (3 mg/kg Q2W) + placebo (PBO), or NIVO + IPI (1 mg/kg + 3 mg/kg Q3W X 4) followed by NIVO 3 mg/kg Q2W, or to IPI (3 mg/kg Q3W X 4) + PBO until disease progression or unacceptable toxicity. PFS, a co-primary endpoint, was evaluated in predefined subgroups.

Results: In the total population, median PFS was 11.5 months for NIVO + IPI vs 2.9 months for IPI alone (hazard ratio [HR] vs IPI, 0.42; P<0.00001), and was 6.9 months for NIVO alone (HR vs IPI, 0.57; P<0.00001). Numerically longer PFS was observed with the combination vs NIVO or IPI alone in all predefined subgroups, including baseline lactate dehydrogenase ˃upper limit of normal (NIVO + IPI: 4.2 months [95% CI: 2.8–9.3] vs NIVO: 2.8 months [95% CI: 2.6–4.0] vs IPI: 2.6 months [95% CI: 2.6–2.8]) and age <65 (NIVO + IPI: 11.7 months [95% CI: 7.0–not reached] vs NIVO: 5.5 months [95% CI: 3.0–8.3] vs IPI: 2.8 months [95% CI: 2.8–3.1]).

The incidence of drug-related grade 3–4 adverse events was 55.0%, 16.3% and 27.3% in the NIVO + IPI, NIVO and IPI groups, respectively. Across pt subgroups, the safety profile was consistent with that observed in the overall safety population.

Conclusions: In pts with treatment-naïve MEL, NIVO + IPI and NIVO alone significantly improved PFS across predefined subgroups. The safety profile of the combination was manageable across subgroups of pts. 

Reused with permission from the European Cancer Congress (ECC). This abstract was accepted at the 2015 ECC Annual Meeting. All rights reserved.