IDMC Recommends GlaxoSmithKline 's Phase III Trial Of MEK/BRAF Combination

(RTTNews) - GlaxoSmithKline plc (GSK.L, GSK) Thursday said the Independent Data Monitoring Committee or IDMC has recommended COMBI-v, a phase III trial of its MEK inhibitor, trametinib, in combination with its BRAF inhibitor, dabrafenib, compared with vemurafenib in patients with metastatic BRAF V600E/K mutation-positive cutaneous melanoma.

The IDMC recommendation was based on an interim analysis which showed an overall survival benefit for the trametinib and dabrafenib combination compared with vemurafenib that passed the pre-specified efficacy stopping boundary. The safety profile of the trametinib and dabrafenib arm was consistent with the safety profile of the combination observed to date.

The company said further analysis of safety and efficacy data is ongoing and will be completed in the coming months.