Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.
By J. Larkin, V. Chiarion-Sileni, R. Gonzalez, J. Grob, P. Rutkowski, C. Lao, C. Cowey, D. Schadendorf, J. Wagstaff, R. Dummer and 21 more. New England Journal of Medicine, 2019
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BACKGROUND Nivolumab plus ipilimumab or nivolumab alone resulted in longer progression-free and overall survival than ipilimumab alone in a trial involving patients with advanced melanoma. We now report 5-year outcomes in the trial. METHODS We randomly assigned patients with previously untreated advanced melanoma to receive one of the following regimens: nivolumab (at a dose of 1 mg per kilogram of body weight) plus ipilimumab (3 mg per kilogram) every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram every 2 weeks); nivolumab (3 mg per kilogram every 2 weeks) plus ipilimumab-matched placebo; or ipilimumab (3 mg per kilogram every 3 weeks for four doses) plus nivolumab-matched placebo. The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group, as compared with the ipilimumab group. RESULTS At a minimum follow-up of 60 months, the median overall survival was more than 60.0 months (median not reached) in the nivolumab-plus-ipilimumab group and 36.9 months in the nivolumab group, as compared with 19.9 months in the ipilimumab group (hazard ratio for death with nivolumab plus ipilimumab vs. ipilimumab, 0.52; hazard ratio for death with nivolumab vs. ipilimumab, 0.63). Overall survival at 5 years was 52% in the nivolumab-plus-ipilimumab group and 44% in the nivolumab group, as compared with 26% in the ipilimumab group. No sustained deterioration of health-related quality of life was observed during or after treatment with nivolumab plus ipilimumab or with nivolumab alone. No new late toxic effects were noted. CONCLUSIONS Among patients with advanced melanoma, sustained long-term overall survival at 5 years was observed in a greater percentage of patients who received nivolumab plus ipilimumab or nivolumab alone than in those who received ipilimumab alone, with no apparent loss of quality of life in the patients who received regimens containing nivolumab. (Funded by Bristol-Myers Squibb and others; CheckMate 067 ClinicalTrials.gov number, NCT01844505.).
Subfields: Molecular Biology, Oncology
View Paper: https://www.semanticscholar.org/paper/facc0b0374314e31f49f2a07d7ba43260f5b0875
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Citations in the corpus
- Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma (2021, methodology): “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 th”
- Acquired Resistance to Immune Checkpoint Inhibitors (2020, background): “…in some diseases (e.g. melanoma, Merkel cell, Hodgkin’s lymphoma, MSI high tumors) (Armand et al., 2018; Chen et al., 2017; Hamid et al., 2019; Larkin et al., 2019; Le et al., 2017; Nghiem et al., 2019) while the response rates in most other approved diseases is limited to 10–25% (Antonia…”
- Regulatory mechanisms of PD-1/PD-L1 in cancers (2024, background): “In advanced melanoma, the five-year survival rates of combined therapy with Nivolumab and Ipilim-umab reach 52%, with a positive response rate of 63.8% in clinical phase II and III trials [371, 372].”