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Soo Park, MD
Soo Park, MD
Posted: Wednesday, October 16, 2024
In patients with advanced melanoma, the final results of the CheckMate 067 trial show continued, ongoing survival benefits for those receiving either the PD-1 inhibitor nivolumab plus the CTLA-4 inhibitor ipilimumab or nivolumab monotherapy compared with ipilimumab alone. Jedd D. Wolchok, MD, PhD, of Weill Cornell Medicine, New York, and colleagues reported these 10-year outcomes in The New England Journal of Medicine. Previous results had pointed toward the same conclusion.
The trial’s 945 patients were randomly assigned on a 1:1:1 basis to the three arms. The investigators found that with a minimum follow-up of 10 years, median overall survival was 71.9 months with nivolumab plus ipilimumab, 36.9 months with nivolumab alone, and 19.9 months with ipilimumab alone.
The findings underscore the prolonged clinical benefit with nivolumab/ipilimumab therapy, the researchers declared. The patients in that arm also experienced a relatively low level of disease spread to the central nervous system. “The survival benefits seen with nivolumab-containing therapies, as compared with ipilimumab monotherapy, persisted across all examined subgroups, including those stratified according to PD-L1 expression and BRAF mutation status,” they added.
The hazard ratios for death were 0.53 for nivolumab plus ipilimumab compared with ipilimumab alone and 0.63 for nivolumab compared with ipilimumab. The median melanoma-specific survival was more than 120 months with nivolumab plus ipilimumab (not reached, with 37% of the patients alive at the end of the trial), 49.4 months with nivolumab, and 21.9 months with ipilimumab.
“Among patients who had been alive and progression-free at 3 years, 10-year melanoma-specific survival was 96% with nivolumab/ipilimumab, 97% with nivolumab, and 88% with ipilimumab,” the team noted, adding that those results suggest “progression-free survival at 3 years is a surrogate marker of long-term disease-specific survival in patients with advanced melanoma who are treated with immune checkpoint inhibitors.”
Disclosure: For full disclosures of the study authors, visit nejm.org.
The New England Journal of Medicine
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