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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...
| Published in: | Journal of Clinical Oncology |
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| ISSN: | 0732-183X 1527-7755 |
| Published: |
American Society of Clinical Oncology (ASCO)
2022
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| Online Access: |
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| URI: | https://cronfa.swan.ac.uk/Record/cronfa58920 |
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| 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 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. |
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| College: |
Faculty of Medicine, Health and Life Sciences |
| 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–Institute of Cancer Research Biomedical Research Centre. |
| Issue: |
2 |
| Start Page: |
127 |
| End Page: |
137 |