Nonsignificant Survival Benefit Seen for Dabrafenib, Trametinib in Melanoma
24 Jun 2024
Clinical ResultClinical Study
MONDAY, June 24, 2024 -- For patients with resected stage III melanoma, adjuvant therapy with dabrafenib plus trametinib is associated with a nonsignificant benefit in terms of overall survival, according to a study published online June 19 in the New England Journal of Medicine.
Georgina V. Long, M.D., Ph.D., from the University of Sydney, and colleagues randomly assigned 870 patients with resected stage III melanoma with BRAF V600 mutations to receive 12 months of dabrafenib plus trametinib or two matched placebos. The median duration of follow-up was 8.33 and 6.87 years for dabrafenib plus trametinib and placebo, respectively.
The researchers found that for overall survival, the Kaplan-Meier estimates favored dabrafenib plus trametinib over placebo, but the benefit was not significant (hazard ratio, 0.80; 95 percent confidence interval, 0.62 to 1.01; P = 0.06). Across several prespecified subgroups, a consistent survival benefit was seen, including among 792 patients with melanoma with a BRAF V600E mutation (hazard ratio for death, 0.75; 95 percent confidence interval, 0.58 to 0.96). Significant benefits were also seen for dabrafenib plus trametinib versus placebo for relapse-free survival (hazard ratio for relapse or death, 0.52; 95 percent confidence interval, 0.43 to 0.63) and for distant metastasis-free survival (hazard ratio for distant metastasis or death, 0.56; 95 percent confidence interval, 0.44 to 0.71). There were no new reports of safety signals.
"Whether or how therapies administered after relapse may have reduced the effect of adjuvant therapy on overall survival is unclear," the authors write.
GlaxoSmithKline and Novartis funded the study; Novartis is the manufacturer of dabrafenib and trametinib.
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