Phase 2 CheckMate 069 Study Suggests Nivolumab Plus Ipilimumab May Improve Overall Survival in Melanoma
Nivolumab plus ipilimumab, in contrast with ipilimumab alone, may improve overall survival of patients with previously untreated, advanced melanoma.
Nivolumab plus ipilimumab, in contrast with ipilimumab alone, may improve overall survival of patients with previously untreated, advanced melanoma, according to a study published in The Lancet Oncology.1
Results from phase 2 and 3 trials show that the addition of nivolumab to ipilimumab significantly improves objective response rate and progression-free survival. As part of the phase 2 CheckMate 069 trial, researchers evaluated 2-year overall survival with these 2 immunotherapy regimens in this patient population.
Among the 142 patients randomly assigned to nivolumab plus ipilimumab or ipilimumab alone, 2-year overall survival was 63.8% (95% CI, 53.3-72.6) for the combination and 53.6% (95% CI, 38.1-66.8) for ipilimumab.
Median overall survival has not yet been reached in either treatment arm.
More than half of patients who received nivolumab plus ipilimumab reported treatment-related grade 3 to 4 adverse events, in contrast with 20% of those who received ipilimumab alone; serious grade 3 to 4 treatment-related adverse events occurred in 36% and 9% of patients, respectively.
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No new types of treatment-related adverse events or treatment-related deaths were observed.
The findings suggest that patient outcomes may be improved with the therapy combination, in contrast with first-line ipilimumab alone.
- Hodi FS, Chesney J, Pavlick AC, et al. Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial. Lancet Oncol. 2016 Sep 8. doi: 10.1016/S1470-2045(16)30366-7 [Epub ahead of print]