Melanoma: FDA Approves Adjuvant Dabrafenib With Trametinib

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The FDA based its approval on the results of the phase 3 COMBI-AD study.
The FDA based its approval on the results of the phase 3 COMBI-AD study.

The US Food and Drug Administration (FDA) approved dabrafenib with trametinib as an adjuvant therapy following complete resection for patients with BRAFV600E- or V600K-mutated melanoma with lymph node involvement, according to a press release.1

The FDA based its approval on results from the phase 3 COMBI-AD study (ClinicalTrials.gov Identification: NCT01682083), for which researchers randomly assigned 870 patients with advanced, high-risk melanoma after complete resection to receive dabrafenib 2 mg once daily plus trametinib 150 mg twice daily or placebo.  

After a median follow-up of 2.8 years, the 3-year relapse-free survival rate was 58% vs 39% among patients in the combination therapy group vs placebo group, respectively (hazard ratio [HR], 0.47; 95% CI, 0.39-0.58; P < .001), representing a 53% reduced risk of disease recurrence or death.

Overall survival (OS) was prolonged in the combination arm as well: the 3-year OS rate among patients in the combination group was 86% compared with 77% in the placebo group (HR, 0.57; 95% CI, 0.42-0.79; P = .0006).2 This result did not, however, meet the pre-specified interim analysis boundaries.

The safety profile of the combination remained consistent with those previously reported for the components individually. No new safety signals were observed.

Reference

  1. Novartis receives FDA approval of Tafinlar + Mekinist for adjuvant treatment of BRAF V600-mutant melanoma [press release]. East Hanover, NJ: Novartis; April 30, 2018. https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-tafinlarr-mekinistr-adjuvant-treatment-braf-v600-mutant-melanoma. Accessed May 1, 2018.
  2. Long GV, Hauschild A, Santinami M, et al. Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma. N Engl J Med. 2017 Nov 9. doi: 10.1056/NEJMoa1708539 [Epub ahead of print]

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