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Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma / James Larkin; Vanna Chiarion-Sileni; Rene Gonzalez; Jean Jacques Grob; C. Lance Cowey; Christopher D. Lao; Dirk Schadendorf; Reinhard Dummer; Michael Smylie; Piotr Rutkowski; Pier F. Ferrucci; Andrew Hill; John Wagstaff; Matteo S. Carlino; John B. Haanen; Michele Maio; Ivan Marquez-Rodas; Grant A. McArthur; Paolo A. Ascierto; Georgina V. Long; Margaret K. Callahan; Michael A. Postow; Kenneth Grossmann; Mario Sznol; Brigitte Dreno; Lars Bastholt; Arvin Yang; Linda M. Rollin; Christine Horak; F. Stephen Hodi; Jedd D. Wolchok

New England Journal of Medicine, Volume: 373, Issue: 1, Pages: 23 - 34

Swansea University Author: Wagstaff, John

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DOI (Published version): 10.1056/NEJMoa1504030

Abstract

This is a randomised phase III trial comparing ipilimumab (Ipi) with nivolumab (Nivo) and the combination of the two Ipi+Nivo) in patients with inoperable stage III and stage IV melanoma. 945 previously untreated patients were randomised 1:1:1 to Nivo alone, the combination of Niv+Ipi or Ipi alone....

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Published in: New England Journal of Medicine
ISSN: 0028-4793 1533-4406
Published: 2015
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URI: https://cronfa.swan.ac.uk/Record/cronfa25005
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Abstract: This is a randomised phase III trial comparing ipilimumab (Ipi) with nivolumab (Nivo) and the combination of the two Ipi+Nivo) in patients with inoperable stage III and stage IV melanoma. 945 previously untreated patients were randomised 1:1:1 to Nivo alone, the combination of Niv+Ipi or Ipi alone. Progression free survival (PFS) and overall survival (OS) were co-primary endpoints. PFS is presented in this paper. The data for OS are currently too immature. The median PFS was 11.5 months for Ipi+Nivo, 2.9 months for Ipi alone and 6.9 months for Nivo alone (p=<0.001). Objective response rates (OR) were 57.6 (p=<0.001), 43.7 (p=<0.001) & 19.0 for ipi+Nivo, Nivo & Ipi respectively. This trial demonstrated that both Nivo alone and Ipi plus Nivo are superior to Ipi alone in terms of both PFS and OR. Grade III & IV treatment related adverse events were seen in 55% of Ipi+Nivo, 27.3% of Ipi alone and 16.3% of Nivo alone patients.
Keywords: Melanoma, Nivolumab, Ipilimumab, Immunotherapy
College: Swansea University Medical School
Issue: 1
Start Page: 23
End Page: 34