The DOI matches its Crossref record; 7 of the 7 references it cites were found in a registry or an index.
Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma
Open accessAbstract
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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Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
Larkin, J., Chiarion-Sileni, V., Gonzalez, R., Grob, J. J., Cowey, C. L., Lao, C. D., Schadendorf, D., Dummer, R., Smylie, M., Rutkowski, P., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1504030 · Cited by 8,157
Self-citationOverall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma
Wolchok, J. D., Chiarion-Sileni, V., Gonzalez, R., Rutkowski, P., Grob, J.-J., Cowey, C. L., Lao, C. D., Wagstaff, J., Schadendorf, D., Ferrucci, P. F., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1709684 · Cited by 5,357 · cited 18×
“OS results at 6.5 years in patient subgroups on the basis of tumor programmed cell death ligand 1 expression level were consistent with those reported previously (Data Supplement).5-7 ORRs at 6.5 years remained unchanged from the previous analysis at 5 years,7 with rates of 58%, 45%, and 19% with the combination, nivo…”
BackgroundMethodResultInfluentialSelf-citationFive-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma
Larkin, J., Chiarion-Sileni, V., Gonzalez, R., Grob, J.-J., Rutkowski, P., Lao, C. D., Cowey, C. L., Schadendorf, D., Wagstaff, J., Dummer, R., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1910836 · Cited by 3,723 · cited 14×
“OS results at 6.5 years in patient subgroups on the basis of tumor programmed cell death ligand 1 expression level were consistent with those reported previously (Data Supplement).5-7 ORRs at 6.5 years remained unchanged from the previous analysis at 5 years,7 with rates of 58%, 45%, and 19% with the combination, nivo…”
BackgroundMethodResultInfluentialSelf-citationNivolumab and ipilimumab versus ipilimumab in untreated melanoma
Postow, M. A., Chesney, J., Pavlick, A. C., Robert, C., Grossmann, K., McDermott, D., Linette, G. P., Meyer, N., Giguere, J. K., Agarwala, S. S., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1414428 · Cited by 2,781
Self-citationHodi, F. S., Chiarion-Sileni, V., Gonzalez, R., Grob, J.-J., Rutkowski, P., Cowey, C. L., Lao, C. D., Schadendorf, D., Wagstaff, J., Dummer, R., et al. (2018) · The Lancet Oncology · doi:10.1016/s1470-2045(18)30700-9 · Cited by 1,399 · cited 17×
“OS results at 6.5 years in patient subgroups on the basis of tumor programmed cell death ligand 1 expression level were consistent with those reported previously (Data Supplement).5-7 ORRs at 6.5 years remained unchanged from the previous analysis at 5 years,7 with rates of 58%, 45%, and 19% with the combination, nivo…”
BackgroundMethodResultInfluentialFive-year outcomes with dabrafenib plus trametinib in metastatic melanoma
Robert, C., Grob, J. J., Stroyakovskiy, D., Karaszewska, B., Hauschild, A., Levchenko, E., Chiarion Sileni, V., Schachter, J., Garbe, C., Bondarenko, I., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1904059 · Cited by 1,389
Self-citationHodi, F. S., Chesney, J., Pavlick, A. C., Robert, C., Grossmann, K. F., McDermott, D. F., Linette, G. P., Meyer, N., Giguere, J. K., Agarwala, S. S., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(16)30366-7 · Cited by 968
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Sangro, B., Chan, S. L., Kelley, R. K., Lau, G., Kudo, M., Sukeepaisarnjaroen, W., Yarchoan, M., De Toni, E. N., Furuse, J., Kang, Y. K., et al. (2024) · Annals of Oncology · doi:10.1016/j.annonc.2024.02.005 · Cited by 365
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Metadata
- Authors
- Wolchok, J. D., Chiarion-Sileni, V., Gonzalez, R., Grob, J.-J., Rutkowski, P., Lao, C. D., Cowey, C. L., Schadendorf, D., Wagstaff, J., Dummer, R., Ferrucci, P. F., Smylie, M., Butler, M. O., Hill, A., Márquez-Rodas, I., Haanen, J. B. A. G., Guidoboni, M., Maio, M., Schöffski, P., Carlino, M. S., Lebbé, C., McArthur, G., Ascierto, P. A., Daniels, G. A., Long, G. V., Bas, T., Ritchings, C., Larkin, J., & Hodi, F. S.
- Venue
- Journal of Clinical Oncology
- Published
- 2022-01-10
- Volume
- 40
- Issue
- 2
- Pages
- 127-137
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W3217126890
- Cited by
- 1,117
- References
- 7
- FWCI
- 58.95
- Type
- journal article
- Language
- en
- Open access
- hybrid
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