GlaxoSmithKline starts late-stage studies of BRAF, MEK inhibitors for melanoma

GlaxoSmithKline began two late-stage trials of investigational drugs for patients with advanced or metastatic melanoma who have a BRAF V600 mutation, the company reported Monday. The studies will examine the ability of the BRAF inhibitor GSK2118436 and the MEK inhibitor GSK1120212 to prevent or slow the progression of melanoma.

"By focusing our research programme on patients with the V600 mutation, we are striving to understand how our investigational MEK and BRAF inhibitors can best be used to treat patients with metastatic melanoma," commented Paolo Paoletti, president of oncology at the drugmaker. According to GlaxoSmithKline, the BRAF V600 mutation occurs in approximately 50 percent to 60 percent of patients with melanoma.

The BRF113683 trial will compare GSK2118436 to dacarbazine in previously untreated patients, while the METRIC trial will compare GSK1120212 to chemotherapy. Both trials, which will involve patients with advanced or metastatic melanoma with a BRAF V600 mutation, have a main goal of progression-free survival.

Other companies are developing BRAF inhibitors for the treatment of melanoma, including Roche and partner Plexxikon, who reported last week that in a late-stage study, RG7204 demonstrated a significant survival benefit in patients with previously untreated advanced melanoma with a mutation in the BRAF gene, compared to dacarbazine.

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