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2019 ASCO: Long-Term Survival With Dabrafenib Plus Trametinib in Metastatic BRAF-Mutated Melanoma

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Key Points

  • Overall survival at 4 and 5 years was 37% and 34%.
  • Overall survival at 5 years was 71% in patients with complete response.

In an extended analysis of the COMBI-d and COMBI-v trials reported at the 2019 ASCO Annual Meeting (Abstract 9507) and in The New England Journal of Medicine, Robert et al found a 5-year overall survival rate of 34% with the combination of dabrafenib and trametinib in previously untreated metastatic melanoma with a BRAF V600E or V600K mutation.

Study Details

The analysis included 563 patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation randomly assigned to receive the BRAF inhibitor dabrafenib 150 mg twice daily plus the MEK inhibitor trametinib 2 mg once daily in the COMBI-d trial (n = 211) and the COMBI-v trial (n = 352).

Progression-Free and Overall Survival

Median duration of follow-up was 22 months. Progression-free survival was 21% at 4 years and 19% at 5 years. Overall survival was 37% at 4 years and 34% at 5 years. In multivariate analysis, baseline factors associated with improved overall survival included Eastern Cooperative Oncology Group performance status (hazard ratio [HR] = 0.49 for 0 vs 1, P < .001), age (HR = 0.92 per 10-year increment, P = .04), sex (HR = 0.68 for female vs male, P < .001), number of organ sites with metastasis (HR = 0.58 for < 3 vs ≥ 3, P < .001), and lactate dehydrogenase level (HR = 0.47 for normal vs elevated, P < .001); these factors were also associated with prolonged progression-free survival. Complete response occurred in 109 patients (19%) and was associated with 5-year overall survival of 71%.

The investigators concluded,“First-line treatment with dabrafenib plus trametinib led to long-term benefit in approximately one-third of the patients who had unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.”

Disclosure: The study was funded by GlaxoSmithKline and Novartis. For full disclosures of the study authors, visit coi.ascopubs.org or nejm.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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