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Soo Park, MD
Soo Park, MD
Posted: Tuesday, August 6, 2024
A study recently presented the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting (Abstract 9500) highlighted final results from the phase III COMBI-AD trial on the use of the BRAF inhibitor dabrafenib plus the MEK inhibitor trametinib in patients with stage III, BRAF-mutated melanoma. Axel Hauschild, MD, PhD, of the University Hospital Schleswig-Holstein, Kiel, Germany, and colleagues reported benefits in overall survival in those with BRAF V600E mutation. Their findings also revealed that relapse-free survival and distant metastasis–free survival were better with dabrafenib plus trametinib vs placebo. These findings were also published in The New England Journal of Medicine.
A total of 870 patients were assigned to one of two arms; the first received dabrafenib (150 mg, twice daily) plus trametinib (2 mg, once daily; n = 438), and the second arm received a matching placebo (n = 432). Treatment duration was 12 months or until disease relapse, unacceptable toxicity, withdrawal of consent, or death.
The median duration of follow-up was 100.0 months in the treatment arm vs 82.5 months in the placebo arm. Overall survival was not attained in the two arms (hazard ratio [HR] = 0.80; 95% confidence interval [CI] = 0.62–1.01; P = .063); however, overall survival benefits were seen across most subgroups, including patients with BRAF V600E mutation (n = 397; HR = 0.75; 95% CI = 0.58–0.96). Additionally, the estimated relapse-free survival (HR = 0.52; 95% CI = 0.43–0.63) and distant metastasis–free survival (HR = 0.56; 95% CI = 0.44–0.71) favored the dabrafenib-plus-trametinib arm.
These findings, according to the study authors, are consistent with published results at 3 and 5 years, with relapse-free survival and distant metastasis–free survival being more favorable in the treatment vs placebo arm.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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