Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma.
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Author
Wolchok, JD
Chiarion-Sileni, V
Gonzalez, R
Grob, J-J
Rutkowski, P
Lao, CD
Cowey, CL
Schadendorf, D
Wagstaff, J
Dummer, R
Ferrucci, PF
Smylie, M
Butler, MO
Hill, A
Márquez-Rodas, I
Haanen, JBAG
Guidoboni, M
Maio, M
Schöffski, P
Carlino, MS
Lebbé, C
McArthur, G
Ascierto, PA
Daniels, GA
Long, GV
Bas, T
Ritchings, C
Larkin, J
Hodi, FS
Type
Journal Article
Metadata
Show full item recordAbstract
<h4>Purpose</h4>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.<h4>Patients and methods</h4>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.<h4>Results</h4>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 <i>BRAF</i>-mutant tumors and 46%, 42%, and 22% in those with <i>BRAF</i>-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.<h4>Conclusion</h4>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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Subject
Humans
Melanoma
Skin Neoplasms
Disease Progression
Antineoplastic Combined Chemotherapy Protocols
Neoplasm Staging
Time Factors
Ipilimumab
Nivolumab
Progression-Free Survival
Research team
Melanoma and Kidney Cancer
Language
eng
Date accepted
2021-10-28
Citation
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022, 40 (2), pp. 127 - 137