Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2017

Characterization of complete responses (CRs) in patients with advanced melanoma (MEL) who received the combination of nivolumab (NIVO) and ipilimumab (IPI), NIVO, or IPI alone (#200)

Caroline Robert 1 , James Larkin 2 , Paolo A. Ascierto 3 , Georgina V. Long 4 , Jessica C. Hassel 5 , Dirk Schadendorf 6 , F. Stephen Hodi 7 , Celeste Lebbe 8 , Jean-Jacques Grob 9 , Kenneth Grossmann 10 , John Wagstaff 11 , Jason Chesney 12 , David Hogg 13 , Oliver Bechter 14 , Ivan Marquez-Rodas 15 , Anna C. Pavlick 16 , Dana Walker 17 , Rafia Bhore 17 , Michael A. Postow 18 , Jedd D. Wolchok 18 , Thomas Gaucher 19 , Rosemary Hemaya
  1. Gustave Roussy and INSERM Unité 981, Villejuif–Paris, France
  2. Royal Marsden Hospital, London, UK
  3. Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy
  4. Melanoma Institute Australia, The University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, Australia
  5. University Hospital Heidelberg, Heidelberg, Germany
  6. University of Essen, Essen, Germany
  7. Dana–Farber Cancer Institute, Boston, MA
  8. Hôpital Saint-Louis, INSERM U976, Université Paris Diderot, Paris, France
  9. Hospital de la Timone, Marseille, France
  10. Huntsman Cancer Institute, Salt Lake City, USA
  11. Singleton Hospital, South West Wales Cancer Institute & Swansea University College of Medicine, Swansea, UK
  12. University of Louisville, Louisville, KY
  13. Princess Margaret Cancer Centre, Toronto, Canada
  14. University Hospitals Leuven, Leuven, Belgium
  15. Hospital General Universitario Gregorio Marañón, Madrid, Spain
  16. New York University, New York, USA
  17. Bristol-Myers Squibb, Princeton, USA
  18. Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, USA
  19. Bristol-Myers Squibb, Mulgrave, VIC, Australia


In clinical studies, 10-15% of patients treated with anti-PD-1 monotherapies achieved durable CRs. NIVO+IPI resulted in higher response rates, longer progression-free survival (PFS), and improved overall survival (OS) vs IPI alone, but with an increased frequency of adverse events (AEs). Here, we characterized CRs among patients who received NIVO+IPI, NIVO, or IPI alone.


In this post hoc analysis, data were pooled for NIVO+IPI (N=409), NIVO (N=526), and IPI (N=362) from the CheckMate 069 (phase 2), 066 (phase 3), and 067 (phase 3) studies in MEL patients. Minimum duration of follow-up was 24 months (median ~31 months).


In the pooled analysis, the CR rate was 18% for NIVO+IPI, 16% for NIVO, and 4% for IPI, with partial responses (PRs) in 41%, 28%, and 14% of patients, respectively. Among 75 CR patients in the NIVO+IPI cohort, 77% are off treatment and 8% received subsequent systemic therapy; 15% had elevated LDH levels and 32% had M1c disease. Median duration of CR has not been reached, with 84% (63/75) remaining in response. After an additional follow-up of 12 months (from the 1-year initial follow-up), 24/166 patients (14%) with a PR converted to a CR. For CR patients in the NIVO+IPI cohort, 2-year PFS and OS rates were 86% and 92%, respectively. Grade 3-4 treatment-related AEs occurred in 60% of NIVO+IPI-treated patients with a CR, 65% with a PR, and 60% with stable disease; 31%, 36%, and 35%, respectively, led to discontinuation. There were no treatment-related deaths.


MEL patients treated with NIVO+IPI had a high rate of durable CRs, with the majority remaining in response and often not requiring additional treatment. Some patients with a PR convert to a CR over time. Three-year data will be presented.

Reused with permission from the European Society for Medical Oncology. All rights reserved.