BRAF V600-mutant melanoma: adding spartalizumab to dabrafenib and trametinib extended median overall survival from 41.6 to 61.5 months in the final COMBI-i analysis

In the randomised phase 3 COMBI-i trial in unresectable or metastatic BRAF V600-mutant melanoma, adding spartalizumab (an anti-PD-1 antibody) to dabrafenib and trametinib yielded a final median overall survival of 61.5 months versus 41.6 months with placebo (HR 0.760; 95% CI 0.598-0.966; 267 vs 265 patients, median follow-up 76.9 months). Key caveat: the trial did NOT meet its primary endpoint of progression-free survival, so the overall survival finding is hypothesis-generating and does not establish a new standard. Toxicity was clearly higher with spartalizumab: pyrexia in 65.9% versus 46.2% of patients and grade 3 or higher adverse events in 57.3% versus 36.7%.