CheckMate 067 (10-year outcomes, nivolumab vs. ipilimumab)
Trial question
What is the effect of nivolumab monotherapy in patients with advanced melanoma?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 631
631 patients (227 female, 404 male).
Inclusion criteria: patients with previously untreated advanced melanoma.
Key exclusion criteria: active brain metastases or leptomeningeal metastases; ocular melanoma; autoimmune disease; requirement of systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of treatment; prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody.
Interventions
N=316 nivolumab (nivolumab 3 mg/kg every 2 weeks plus placebo).
N=315 ipilimumab (ipilimumab 3 mg/kg every 3 weeks for 4 doses plus placebo).
Primary outcome
Median overall survival at 10 years
36.9 months
19.9 months
36.9 months
27.7 months
18.4 months
9.2 months
0.0 months
Nivolumab
Ipilimumab
Significant
increase ▲
Significant increase in median overall survival at 10 years (36.9 months vs. 19.9 months; HR 1.59, 95% CI 1.32 to 1.92).
Secondary outcomes
Significant increase in melanoma-specific survival at 10 years (44% vs. 23%; HR 1.7, 95% CI 1.37 to 2.04).
Significant increase in progression-free survival at 10 years (23% vs. 6%; HR 1.9, 95% CI 1.54 to 2.22).
Significant increase in objective response (44.9% vs. 19%; OR 3.59, 95% CI 2.49 to 5.16).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with previously untreated advanced melanoma, nivolumab was superior to ipilimumab with respect to median overall survival at 10 years.
Reference
Jedd D Wolchok, Vanna Chiarion-Sileni, Piotr Rutkowski et al. Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma. N Engl J Med. 2025 Jan 2;392(1):11-22.
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