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Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma

Jedd D. Wolchok, Vanna Chiarion-Sileni, Rene Gonzalez, Jean-Jacques Grob, Piotr Rutkowski, Christopher D. Lao, C. Lance Cowey, Dirk Schadendorf, John Wagstaff, Reinhard Dummer, Pier Francesco Ferrucci, Michael Smylie, Marcus O. Butler, Andrew Hill, Ivan Márquez-Rodas, John B. A. G. Haanen, Massimo Guidoboni, Michele Maio, Patrick Schöffski, Matteo S. Carlino, Céleste Lebbé, Grant McArthur, Paolo A. Ascierto, Gregory A. Daniels, Georgina V. Long, Tuba Bas, Corey Ritchings, James Larkin, F. Stephen Hodi

Journal of Clinical Oncology, Volume: 40, Issue: 2, Pages: 127 - 137

Swansea University Author: John Wagstaff

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DOI (Published version): 10.1200/jco.21.02229

Abstract

PURPOSE In the phase III CheckMate 067 trial, durable clinical benefit was demonstrated previously with nivolumab plus ipilimumab and nivolumab alone versus ipilimumab. Here, we report 6.5-year efficacy and safety outcomes. PATIENTS AND METHODS Patients with previously untreated unresectable stage I...

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Published in: Journal of Clinical Oncology
ISSN: 0732-183X 1527-7755
Published: American Society of Clinical Oncology (ASCO) 2022
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URI: https://cronfa.swan.ac.uk/Record/cronfa58920
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PATIENTS AND METHODS Patients with previously untreated unresectable stage III or stage IV melanoma were randomly assigned 1:1:1 to receive nivolumab 1 mg/kg plus ipilimumab 3 mg/kg once every 3 weeks (four doses) followed by nivolumab 3 mg/kg once every 2 weeks (n = 314), nivolumab 3 mg/kg once every 2 weeks (n = 316), or ipilimumab 3 mg/kg once every 3 weeks (four doses; n = 315). Coprimary end points were progression-free survival and overall survival (OS) with nivolumab plus ipilimumab or nivolumab versus ipilimumab. Secondary end points included objective response rate, descriptive efficacy assessments of nivolumab plus ipilimumab versus nivolumab alone, and safety. Melanoma-specific survival (MSS; descriptive analysis), which excludes deaths unrelated to melanoma, was also evaluated. RESULTS Median OS (minimum follow-up, 6.5 years) was 72.1, 36.9, and 19.9 months in the combination, nivolumab, and ipilimumab groups, respectively. Median MSS was not reached, 58.7, and 21.9 months, respectively; 6.5-year OS rates were 57%, 43%, and 25% in patients with BRAF-mutant tumors and 46%, 42%, and 22% in those with BRAF&#x2013;wild-type tumors, respectively. In patients who discontinued treatment, the median treatment-free interval was 27.6, 2.3, and 1.9 months, respectively. Since the 5-year analysis, no new safety signals were observed. CONCLUSION These 6.5-year CheckMate 067 results, which include the longest median OS in a phase III melanoma trial reported to date and the first report of MSS, showed durable, improved clinical outcomes with nivolumab plus ipilimumab or nivolumab versus ipilimumab in patients with advanced melanoma and, in descriptive analyses, with the combination over nivolumab monotherapy.</abstract><type>Journal Article</type><journal>Journal of Clinical Oncology</journal><volume>40</volume><journalNumber>2</journalNumber><paginationStart>127</paginationStart><paginationEnd>137</paginationEnd><publisher>American Society of Clinical Oncology (ASCO)</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>0732-183X</issnPrint><issnElectronic>1527-7755</issnElectronic><keywords/><publishedDay>10</publishedDay><publishedMonth>1</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-01-10</publishedDate><doi>10.1200/jco.21.02229</doi><url/><notes/><college>COLLEGE NANME</college><department>Medical School - School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>SGMED</DepartmentCode><institution>Swansea University</institution><apcterm/><funders>Supported by Bristol Myers Squibb, grant P30CA008748 to J. D. W. from the National Cancer Institute, and a grant to J. L. from the National Institute for Health Research Royal Marsden&#x2013;Institute of Cancer Research Biomedical Research Centre.</funders><lastEdited>2022-01-12T12:40:04.6814725</lastEdited><Created>2021-12-06T13:48:24.4255569</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>Jedd D.</firstname><surname>Wolchok</surname><order>1</order></author><author><firstname>Vanna</firstname><surname>Chiarion-Sileni</surname><order>2</order></author><author><firstname>Rene</firstname><surname>Gonzalez</surname><order>3</order></author><author><firstname>Jean-Jacques</firstname><surname>Grob</surname><order>4</order></author><author><firstname>Piotr</firstname><surname>Rutkowski</surname><order>5</order></author><author><firstname>Christopher D.</firstname><surname>Lao</surname><order>6</order></author><author><firstname>C. Lance</firstname><surname>Cowey</surname><order>7</order></author><author><firstname>Dirk</firstname><surname>Schadendorf</surname><order>8</order></author><author><firstname>John</firstname><surname>Wagstaff</surname><order>9</order></author><author><firstname>Reinhard</firstname><surname>Dummer</surname><order>10</order></author><author><firstname>Pier Francesco</firstname><surname>Ferrucci</surname><order>11</order></author><author><firstname>Michael</firstname><surname>Smylie</surname><order>12</order></author><author><firstname>Marcus O.</firstname><surname>Butler</surname><order>13</order></author><author><firstname>Andrew</firstname><surname>Hill</surname><order>14</order></author><author><firstname>Ivan</firstname><surname>M&#xE1;rquez-Rodas</surname><order>15</order></author><author><firstname>John B. A. G.</firstname><surname>Haanen</surname><order>16</order></author><author><firstname>Massimo</firstname><surname>Guidoboni</surname><order>17</order></author><author><firstname>Michele</firstname><surname>Maio</surname><order>18</order></author><author><firstname>Patrick</firstname><surname>Sch&#xF6;ffski</surname><order>19</order></author><author><firstname>Matteo S.</firstname><surname>Carlino</surname><order>20</order></author><author><firstname>C&#xE9;leste</firstname><surname>Lebb&#xE9;</surname><order>21</order></author><author><firstname>Grant</firstname><surname>McArthur</surname><order>22</order></author><author><firstname>Paolo A.</firstname><surname>Ascierto</surname><order>23</order></author><author><firstname>Gregory A.</firstname><surname>Daniels</surname><order>24</order></author><author><firstname>Georgina V.</firstname><surname>Long</surname><order>25</order></author><author><firstname>Tuba</firstname><surname>Bas</surname><order>26</order></author><author><firstname>Corey</firstname><surname>Ritchings</surname><order>27</order></author><author><firstname>James</firstname><surname>Larkin</surname><order>28</order></author><author><firstname>F. 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spelling 2022-01-12T12:40:04.6814725 v2 58920 2021-12-06 Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma fdab5e9e2fe06c93d3ffa19c816bdcf6 John Wagstaff John Wagstaff true false 2021-12-06 SGMED PURPOSE In the phase III CheckMate 067 trial, durable clinical benefit was demonstrated previously with nivolumab plus ipilimumab and nivolumab alone versus ipilimumab. Here, we report 6.5-year efficacy and safety outcomes. PATIENTS AND METHODS Patients with previously untreated unresectable stage III or stage IV melanoma were randomly assigned 1:1:1 to receive nivolumab 1 mg/kg plus ipilimumab 3 mg/kg once every 3 weeks (four doses) followed by nivolumab 3 mg/kg once every 2 weeks (n = 314), nivolumab 3 mg/kg once every 2 weeks (n = 316), or ipilimumab 3 mg/kg once every 3 weeks (four doses; n = 315). Coprimary end points were progression-free survival and overall survival (OS) with nivolumab plus ipilimumab or nivolumab versus ipilimumab. Secondary end points included objective response rate, descriptive efficacy assessments of nivolumab plus ipilimumab versus nivolumab alone, and safety. Melanoma-specific survival (MSS; descriptive analysis), which excludes deaths unrelated to melanoma, was also evaluated. RESULTS Median OS (minimum follow-up, 6.5 years) was 72.1, 36.9, and 19.9 months in the combination, nivolumab, and ipilimumab groups, respectively. Median MSS was not reached, 58.7, and 21.9 months, respectively; 6.5-year OS rates were 57%, 43%, and 25% in patients with BRAF-mutant tumors and 46%, 42%, and 22% in those with BRAF–wild-type tumors, respectively. In patients who discontinued treatment, the median treatment-free interval was 27.6, 2.3, and 1.9 months, respectively. Since the 5-year analysis, no new safety signals were observed. CONCLUSION These 6.5-year CheckMate 067 results, which include the longest median OS in a phase III melanoma trial reported to date and the first report of MSS, showed durable, improved clinical outcomes with nivolumab plus ipilimumab or nivolumab versus ipilimumab in patients with advanced melanoma and, in descriptive analyses, with the combination over nivolumab monotherapy. Journal Article Journal of Clinical Oncology 40 2 127 137 American Society of Clinical Oncology (ASCO) 0732-183X 1527-7755 10 1 2022 2022-01-10 10.1200/jco.21.02229 COLLEGE NANME Medical School - School COLLEGE CODE SGMED Swansea University Supported by Bristol Myers Squibb, grant P30CA008748 to J. D. W. from the National Cancer Institute, and a grant to J. L. from the National Institute for Health Research Royal Marsden–Institute of Cancer Research Biomedical Research Centre. 2022-01-12T12:40:04.6814725 2021-12-06T13:48:24.4255569 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Jedd D. Wolchok 1 Vanna Chiarion-Sileni 2 Rene Gonzalez 3 Jean-Jacques Grob 4 Piotr Rutkowski 5 Christopher D. Lao 6 C. Lance Cowey 7 Dirk Schadendorf 8 John Wagstaff 9 Reinhard Dummer 10 Pier Francesco Ferrucci 11 Michael Smylie 12 Marcus O. Butler 13 Andrew Hill 14 Ivan Márquez-Rodas 15 John B. A. G. Haanen 16 Massimo Guidoboni 17 Michele Maio 18 Patrick Schöffski 19 Matteo S. Carlino 20 Céleste Lebbé 21 Grant McArthur 22 Paolo A. Ascierto 23 Gregory A. Daniels 24 Georgina V. Long 25 Tuba Bas 26 Corey Ritchings 27 James Larkin 28 F. Stephen Hodi 29 58920__21810__ddca67c539cf400490a1b94750b7fa1d.pdf 58920.pdf 2021-12-06T13:52:13.4291017 Output 868238 application/pdf Version of Record true Licensed under the Creative Commons Attribution 4.0 License true eng http://creativecommons.org/licenses/by/4.0/
title Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma
spellingShingle Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma
John Wagstaff
title_short Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma
title_full Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma
title_fullStr Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma
title_full_unstemmed Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma
title_sort Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma
author_id_str_mv fdab5e9e2fe06c93d3ffa19c816bdcf6
author_id_fullname_str_mv fdab5e9e2fe06c93d3ffa19c816bdcf6_***_John Wagstaff
author John Wagstaff
author2 Jedd D. Wolchok
Vanna Chiarion-Sileni
Rene Gonzalez
Jean-Jacques Grob
Piotr Rutkowski
Christopher D. Lao
C. Lance Cowey
Dirk Schadendorf
John Wagstaff
Reinhard Dummer
Pier Francesco Ferrucci
Michael Smylie
Marcus O. Butler
Andrew Hill
Ivan Márquez-Rodas
John B. A. G. Haanen
Massimo Guidoboni
Michele Maio
Patrick Schöffski
Matteo S. Carlino
Céleste Lebbé
Grant McArthur
Paolo A. Ascierto
Gregory A. Daniels
Georgina V. Long
Tuba Bas
Corey Ritchings
James Larkin
F. Stephen Hodi
format Journal article
container_title Journal of Clinical Oncology
container_volume 40
container_issue 2
container_start_page 127
publishDate 2022
institution Swansea University
issn 0732-183X
1527-7755
doi_str_mv 10.1200/jco.21.02229
publisher American Society of Clinical Oncology (ASCO)
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 PURPOSE In the phase III CheckMate 067 trial, durable clinical benefit was demonstrated previously with nivolumab plus ipilimumab and nivolumab alone versus ipilimumab. Here, we report 6.5-year efficacy and safety outcomes. PATIENTS AND METHODS Patients with previously untreated unresectable stage III or stage IV melanoma were randomly assigned 1:1:1 to receive nivolumab 1 mg/kg plus ipilimumab 3 mg/kg once every 3 weeks (four doses) followed by nivolumab 3 mg/kg once every 2 weeks (n = 314), nivolumab 3 mg/kg once every 2 weeks (n = 316), or ipilimumab 3 mg/kg once every 3 weeks (four doses; n = 315). Coprimary end points were progression-free survival and overall survival (OS) with nivolumab plus ipilimumab or nivolumab versus ipilimumab. Secondary end points included objective response rate, descriptive efficacy assessments of nivolumab plus ipilimumab versus nivolumab alone, and safety. Melanoma-specific survival (MSS; descriptive analysis), which excludes deaths unrelated to melanoma, was also evaluated. RESULTS Median OS (minimum follow-up, 6.5 years) was 72.1, 36.9, and 19.9 months in the combination, nivolumab, and ipilimumab groups, respectively. Median MSS was not reached, 58.7, and 21.9 months, respectively; 6.5-year OS rates were 57%, 43%, and 25% in patients with BRAF-mutant tumors and 46%, 42%, and 22% in those with BRAF–wild-type tumors, respectively. In patients who discontinued treatment, the median treatment-free interval was 27.6, 2.3, and 1.9 months, respectively. Since the 5-year analysis, no new safety signals were observed. CONCLUSION These 6.5-year CheckMate 067 results, which include the longest median OS in a phase III melanoma trial reported to date and the first report of MSS, showed durable, improved clinical outcomes with nivolumab plus ipilimumab or nivolumab versus ipilimumab in patients with advanced melanoma and, in descriptive analyses, with the combination over nivolumab monotherapy.
published_date 2022-01-10T04:15:49Z
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