- 4 years of follow-up to the phase 3 CheckMate 067 trial indicate improved survival outcome of patients with advanced melanoma treated with first-line nivolumab+ipilimumab or nivolumab alone.
Why this matters
- This report presents updated efficacy and safety data of CheckMate 067, which had previously shown significant benefits in response and survival outcomes for ipilimumab+nivolumab or nivolumab monotherapy vs ipilimumab monotherapy.
- Nivolumab+ipilimumab was associated with superior OS compared with ipilimumab alone (median OS not reached vs 19.9 months; HR, 0.54; P<.0001>
- Nivolumab alone was associated with superior OS compared with ipilimumab alone (median OS, 36.9 vs 19.9 months; HR, 0.65; P<.0001>
- Treatment-related grade 3/4 adverse events were reported in 59% of nivolumab+ipilimumab patients, 22% of nivolumab-alone patients, and 28% of ipilimumab-alone patients.
- There were 2 treatment-related deaths in the nivolumab plus ipilimumab group, 1 in the nivolumab-alone group, and 1 in ipilimumab-alone group.
- 945 patients with stage III/IV melanoma were randomly assigned to nivolumab+ipilimumab (n=314), nivolumab alone (n=316), or ipilimumab alone (n=315), and were analyzed for survival and safety outcomes during a median 46.9-month follow-up.
- Funding: Bristol-Myers Squibb.
- No statistical comparison between nivolumab+ipilimumab and nivolumab alone.