Trametinib and dabrafenib gives overall survival benefit compared to vemurafenib

17 July 2014

GlaxoSmithKline (LSE/NYSE: GSK) says that the Independent Data Monitoring Committee (IDMC) has recommended a Phase III study of its MEK inhibitor, trametinib, in combination with its BRAF inhibitor, dabrafenib, compared to vemurafenib in patients with BRAF V600E or V600K mutation-positive unreselectable or metastatic cutaneous melanoma be stopped early.

This recommendation is based on an interim analysis demonstrating an overall survival benefit for the trametinib and dabrafenib combination compared to vemurafenib that crossed the pre-specified stopping boundary. The safety profile of this profile was consistent with the safety profile of the combination observed to date.

Further analysis of safety and efficacy data, beyond headline data, will be completed in the coming months, and eligible patients in the trial who were randomly allocated the vemurafenib arm will be allowed to cross over to the trametinib and dabrafenib combination.

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