A phase 3 trial comparing a 2-drug combination with a single agent in advanced melanoma was stopped early because of survival benefit.
The trial was comparing the combination of the MEK inhibitor trametinib (Mekinist, GlaxoSmithKline) plus the BRAF inhibitor dabrafenib (Tafinlar, GlaxoSmithKline) with the BRAF inhibitor vemurafenib (Zelboraf, Roche) alone in patients with unresectable or metastatic cutaneous melanoma who carry theBRAF V600E or BRAF V600K mutation.
The Independent Data Monitoring Committee (IDMC) recommended that the trial, known as COMBI-v (MEK116513), be stopped after an interim analysis demonstrated an overall survival benefit for the trametinib and dabrafenib combination that crossed the prespecified efficacy stopping boundary, according to a GlaxoSmithKline statement.
This is first trial to demonstrate that 2 targeted therapies are better than 1 in advanced melanoma in terms of a survival benefit.
All 3 of the targeted therapies are approved for first-line use in this population of advanced-disease patients.
The trametinib and dabrafenib combination is approved for this indication in the United States under the Accelerated Approval Program of the US Food and Drug Administration. However, the combination is not yet approved in Europe.
Today's IDMC recommendation is based on "headline" data, according to the company, and further analysis of efficacy data is ongoing.
Eligible study patients who were randomized to the vemurafenib group will be allowed to cross over to receive treatment with the combination.
The safety profile of the trametinib and dabrafenib combination was "consistent" with the safety profile of the combination observed to date, according to the company.
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