Journal article 1240 views 1857 downloads
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: John Wagstaff
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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....
| Published in: | New England Journal of Medicine |
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| ISSN: | 0028-4793 1533-4406 |
| Published: |
2015
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| Online Access: |
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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. |
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| Keywords: |
Melanoma, Nivolumab, Ipilimumab, Immunotherapy |
| College: |
Faculty of Medicine, Health and Life Sciences |
| Issue: |
1 |
| Start Page: |
23 |
| End Page: |
34 |