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Melanoma and other skin tumours

3982 - Regional differences in overall survival (OS) in patients with advanced melanoma (MEL) who received nivolumab (NIVO) combined with ipilimumab (IPI) or NIVO alone in a phase 3 trial (CheckMate 067)

Date

11 Sep 2017

Session

Melanoma and other skin tumours

Presenters

Jean-Jacques Grob

Citation

Annals of Oncology (2017) 28 (suppl_5): v428-v448. 10.1093/annonc/mdx377

Authors

J. Grob1, D. Schadendorf2, J. Wagstaff3, I. Márquez-Rodas4, C. Lebbé5, P.A. Ascierto6, F..S. Hodi7, K. Grossmann8, J.C. Hassel9, D. Walker10, R. Bhore10, J. Larkin11, J.D. Wolchok12

Author affiliations

  • 1 Dermatology, Hospital de la Timone, 13885 - Marseille/FR
  • 2 Department Of Dermatology, University of Essen, 45417 - Essen/DE
  • 3 Medical Oncology, South West Wales Cancer Institute, Singleton Hospital, Swansea/GB
  • 4 Servicio De Oncología Médica, Hospital General Universitario Gregorio Marañón, Madrid/ES
  • 5 Aphp Dermatology And Cic Departments, Hôpital Saint-Louis, INSERM U976, Université Paris Diderot, Paris/FR
  • 6 Department Of Medical Oncology, Istituto Nazionale Tumori Fondazione Pascale, Naples/IT
  • 7 Medical Oncology, Dana–Farber Cancer Institute, Boston/US
  • 8 Oncology, Huntsman Cancer Institute, Salt Lake City/US
  • 9 Department Of Dermatology And Nct, University Hospital Heidelberg and National Center for Tumor Diseases, Heidelberg/DE
  • 10 Oncology, Bristol-Myers Squibb, Princeton/US
  • 11 Department Of Medical Oncology, Royal Marsden Hospital, London/GB
  • 12 Oncology, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York/US
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Resources

Abstract 3982

Background

NIVO+IPI and NIVO significantly improved PFS and OS vs. IPI alone in the CheckMate 067 study. Descriptively, NIVO+IPI showed longer OS than NIVO (hazard ratio: 0.88), with 2-year OS rates of 64% and 59%, respectively. Post-hoc analyses by region were performed to evaluate potential differences between patients (pts) treated in the EU and those treated in the USA.

Methods

Baseline patient characteristics, safety and efficacy were evaluated in the two highest enrolling regions (EU, 55% and USA, 22%) using data from the CheckMate 067 study. Minimum follow-up of the pts was 28 months.

Results

EU pts were more likely to have M1c disease than USA pts (60% vs 53%), and more likely to have BRAF wild-type (WT) tumors (69% vs 59%). In a multivariate analysis, which adjusted for baseline factors, the only significant interaction between NIVO+IPI and NIVO was by region. Adjusted hazard ratios (HRs) for OS in the NIVO+IPI vs NIVO groups were 0.90 (0.66–1.23) for the EU and 0.53 (0.29–0.98) for the USA. Across all arms, 2-year OS rates were lower in the EU vs USA pts, particularly for pts with BRAF WT tumors (Table). In pts with BRAF mutant tumors, similar OS outcomes were observed between regions. Treatment exposure, safety, management of adverse events, and use of subsequent therapies did not differ substantially between the two regions. Objective response rates and progression-free survival were also similar between the two regions.Table:

1222PD

2-yr OS ratesITT PopulationEUUSA
OverallBRAF WTBRAF MutantOverallBRAF WTBRAF Mutant
NRateNRateNRateNRateNRateNRateNRate
NIVO+IPI31464%17760%12255%5573%6478%4077%2479%
NIVO31659%17056%10752%6363%6864%5263%1667%
IPI31545%17040%11438%5645%7552%5053%2550%
HR0.880.901.030.690.530.610.65
(95% CI)*(0.69–1.12)(0.66–1.23)(0.72–1.48)(0.37–1.30)(0.29–0.98)(0.30–1.23)(0.20–2.13)
*

NIVO+IPI vs NIVO.

Conclusions

Differences in OS between the EU and the USA appear to be largely due to poorer survival outcomes in EU pts with BRAF WT tumors, which likely impacted OS differences between NIVO+IPI and NIVO in the overall population. Additional analyses by region, the first report of 3-year OS, as well as analyses by tumor mutational burden will be presented. Acknowledgement: J. Larkin and J.D. Wolchok contributed equally to this study.

Clinical trial identification

NCT01844505

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

Bristol-Myers Squibb

Disclosure

J-J. Grob: Served as a consultant for Bristol-Myers Squibb, GSK, Novartis, Roche, Merck, Amgen; participated on speakers’ bureau for Bristol-Myers Squibb, GSK, Roche; travel funding from Roche; recipient of research funding from Bristol-Myers Squibb and Roche. D. Schadendorf: Served as a consultant or advisor for Roche/Genentech, Novartis, Bristol-Myers Squibb, Merck Sharp & Dohme, Merck Serono, Sysmex, Amgen, Grunenthal Group, Immunocore; participated on a speakers’ bureau for Roche, Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis, Amgen, Incyte, Pierre Fabre; travel funding from Roche/Genentech, Bristol-Myers Squibb, Amgen, Merck, Merck Serono, Novartis; paid honoraria from Roche/Genentech, Novartis, Amgen, Bristol-Myers Squibb, Merck Sharp & Dohme, Sysmex, Immunocore, Grunenthal Group, Merck Serono, Agenus, Array BioPharma, LEO Pharma, Incyte, Pfizer, Pierre Fabre, Philogen, Regeneron; received institutional research funding from Bristol-Myers Squibb and Novartis. J. Wagstaff: Paid honoraria from Bristol-Myers Squibb, Merck, Roche, Astellas, Pfizer, Novartis; Consultant for Bristol-Myers Squibb, Merck, Roche, Astellas, Pfizer, Novartis; participated in speakers’ bureau for Bristol-Myers Squibb, Novartis, Astellas; travel funding from Bristol-Myers Squibb, Novartis, Astellas. I. Márquez-Rodas: Paid honoraria from Novartis, Roche, MSD, Bristol-Myers Squibb; served as a consultant for Novartis, Roche, MSD, Bristol-Myers Squibb, Amgen, Bioncotech; travel funding from MSD, Bristol-Myers Squibb, Amgen C. Lebbé: Served on an advisory board for Bristol-Myers Squibb, MSD, Roche, GSK, and Novartis. P.A. Ascierto: Served as a consultant for Bristol-Myers Squibb, Roche-GNE, MSD, Novartis, Array, Amgen, Merck-Serono, Pierre-Fabre; institution received research funding from Bristol-Myers Squibb, Roche-Genentech, Array F.S. Hodi: Employee: Dana-Farber Cancer Institute; consultant: MSD, Novartis, GNE/Roche, Amgen, EMD Serono; travel: Novartis and Bristol-Myers Squibb; patent pending royalties per inst policy; other Bristol-Myers Squibb & GNE/Roche; institutional research funding: Bristol-Myers Squibb, MSD, GNE/Roche, Novartis. J.C. Hassel: Payments for trial procedures according to study protocol from Bristol-Myers Squibb; honoraria: Bristol-Myers Squibb, MSD, Roche, GSK, Novartis, Amgen; research grant/funding: Bristol-Myers Squibb; travel: Bristol-Myers Squibb, MSD, Roche, GSK, Novartis, Amgen. D. Walker: Employed by Bristol-Myers Squibb; Immediate family member has stock or other ownership in Antares Pharma. R. Bhore: Employed by Bristol-Myers Squibb and owns stock in Bristol-Myers Squibb J. Larkin: Received research funding from Bristol-Myers Squibb, MSD, Novartis, and Pfizer; travel funding from Bristol-Myers Squibb, MSD, Pfizer, EISAI, GSK, and Roche. J.D. Wolchok: Consultant: Bristol-Myers Squibb, Merck, MedImmune, Ziopharm, Polynoma, Polaris, Jounce, GSK; Research funding: Bristol-Myers Squibb, Merck, MedImmune, GSK; patent issued for DNA vaccine of cancer in companion animals (co-investor). All other authors have declared no conflicts of interest.

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