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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: 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....

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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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The median PFS was 11.5 months for Ipi+Nivo, 2.9 months for Ipi alone and 6.9 months for Nivo alone (p=&lt;0.001). Objective response rates (OR) were 57.6 (p=&lt;0.001), 43.7 (p=&lt;0.001) &amp; 19.0 for ipi+Nivo, Nivo &amp; 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. 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Stephen</firstname><surname>Hodi</surname><order>30</order></author><author><firstname>Jedd D.</firstname><surname>Wolchok</surname><order>31</order></author></authors><documents><document><filename>0025005-20072017114154.pdf</filename><originalFilename>nejmoa1504030.pdf</originalFilename><uploaded>2017-07-20T11:41:54.2270000</uploaded><type>Output</type><contentLength>618622</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><embargoDate>2017-07-20T00:00:00.0000000</embargoDate><copyrightCorrect>true</copyrightCorrect><language>eng</language></document></documents><OutputDurs/></rfc1807>
spelling 2019-07-16T10:41:15.0809852 v2 25005 2015-12-09 Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma fdab5e9e2fe06c93d3ffa19c816bdcf6 John Wagstaff John Wagstaff true false 2015-12-09 SGMED 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. Journal Article New England Journal of Medicine 373 1 23 34 0028-4793 1533-4406 Melanoma, Nivolumab, Ipilimumab, Immunotherapy 31 5 2015 2015-05-31 10.1056/NEJMoa1504030 COLLEGE NANME Medical School - School COLLEGE CODE SGMED Swansea University 2019-07-16T10:41:15.0809852 2015-12-09T16:26:25.5260909 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine James Larkin 1 Vanna Chiarion-Sileni 2 Rene Gonzalez 3 Jean Jacques Grob 4 C. Lance Cowey 5 Christopher D. Lao 6 Dirk Schadendorf 7 Reinhard Dummer 8 Michael Smylie 9 Piotr Rutkowski 10 Pier F. Ferrucci 11 Andrew Hill 12 John Wagstaff 13 Matteo S. Carlino 14 John B. Haanen 15 Michele Maio 16 Ivan Marquez-Rodas 17 Grant A. McArthur 18 Paolo A. Ascierto 19 Georgina V. Long 20 Margaret K. Callahan 21 Michael A. Postow 22 Kenneth Grossmann 23 Mario Sznol 24 Brigitte Dreno 25 Lars Bastholt 26 Arvin Yang 27 Linda M. Rollin 28 Christine Horak 29 F. Stephen Hodi 30 Jedd D. Wolchok 31 0025005-20072017114154.pdf nejmoa1504030.pdf 2017-07-20T11:41:54.2270000 Output 618622 application/pdf Version of Record true 2017-07-20T00:00:00.0000000 true eng
title Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
spellingShingle Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
John Wagstaff
title_short Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
title_full Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
title_fullStr Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
title_full_unstemmed Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
title_sort Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
author_id_str_mv fdab5e9e2fe06c93d3ffa19c816bdcf6
author_id_fullname_str_mv fdab5e9e2fe06c93d3ffa19c816bdcf6_***_John Wagstaff
author John Wagstaff
author2 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
format Journal article
container_title New England Journal of Medicine
container_volume 373
container_issue 1
container_start_page 23
publishDate 2015
institution Swansea University
issn 0028-4793
1533-4406
doi_str_mv 10.1056/NEJMoa1504030
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
active_str 0
description 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.
published_date 2015-05-31T03:29:43Z
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