Adjuvant Dabrafenib Plus Trametinib for Stage III BRAF V600–Mutated Melanoma: Final Results of the COMBI-AD Trial

Source: The Asco Post, August 2024

Georgina V. Long, MD, PhD, of the Melanoma Institute Australia and the University of Sydney, and colleagues reported the final follow-up analysis of the phase III COMBI-AD trial at the 2024 ASCO Annual Meeting (Abstract 9500) and published their findings in The New England Journal of Medicine. With a maximum follow-up of more than 10 years, and a median follow-up of 8 years, continued improvements were seen in relapse-free and distant metastasis–free survival, as well as a 20% lower risk of death, with the adjuvant combination of the BRAF-targeted agent dabrafenib plus the MEK inhibitor trametinib in patients with resected stage III melanoma and BRAF V600E or V600K mutations.

The previously reported primary analysis revealed a significantly longer duration of relapse-free survival with 12 months of treatment with the combination. It supported the April 2018 U.S. Food and Drug Administration approval of dabrafenib plus trametinib in this setting.

“[Additionally], the 5-year results of this trial showed that adjuvant therapy with this combination resulted in longer relapse-free survival and distant metastasis–free survival than the placebos,” the investigators remarked. “Longer-term data were needed, including data regarding overall survival.”
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