GSK announces start of Phase III programme for combination of dabrafenib (GSK2118436) and trametinib (GSK1120212) in BRAF V600 mutation-positive metastatic cutaneous melanoma

London UK —¬†GlaxoSmithKline plc. today announced the start of a Phase III programme evaluating the combination of dabrafenib, its BRAF inhibitor, and trametinib, its MEK inhibitor, in patients with BRAF mutation-positive metastatic cutaneous melanoma.

The studies comprising the programme are:

  • COMBI-d (Combination of MEK and BRAF Inhibitors versus dabrafenib), a Phase III trial of the combination of its MEK inhibitor, trametinib, and its BRAF inhibitor, dabrafenib, in patients with BRAF V600E or V600K mutation-positive metastatic cutaneous melanoma. This global trial will evaluate whether combining the two investigational agents is better than dabrafenib single-agent therapy in stopping or slowing the progression of metastatic melanoma (Progression Free Survival).
  • COMBI-v (Combination of MEK and BRAF Inhibitors versus vemurafenib), a Phase III trial of the combination of its MEK inhibitor, trametinib, and its BRAF inhibitor, dabrafenib, in patients with BRAF V600E or V600K mutation-positive metastatic cutaneous melanoma. This global trial will evaluate whether combining the two investigational agents is better than single-agent therapy with vemurafenib, an approved BRAF inhibitor, in improving the overall survival of patients with metastatic melanoma (Overall survival).
    Both studies will evaluate the safety profile of the dabrafenib-trametinib combination.

Read More at GlaxoSmithKline plc.

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