GlaxoSmithKline initiates Ph III study to test dabrafenib and trametinib combo for BRAF positive melanoma

UK pharma giant GlaxoSmithKline (LSE: GSK) has initiated COMBI-AD, a Phase III study evaluating the combination of dabrafenib, its BRAF inhibitor and trametinib, its MEK inhibitor as adjuvant therapy for melanoma in-licensed from Japan Tobacco.

This global study will investigate whether combining the two investigational agents can delay or prevent the recurrence of melanoma (Relapse Free Survival) in patients with Stage IIIa, IIIb, or IIIc BRAF V600E or V600K mutation-positive melanoma that has been completely removed by surgery. The study will also evaluate the safety profile of the dabrafenib-trametinib combination in this treatment setting.

According to findings by health care advisory firm Decision Resources, interviewed experts indicated that they are eagerly awaiting the results of the clinical trial combining GSK’s dabrafenib with trametinib, an approach they are hopeful could delay the development of resistance to BRAF inhibitors. However, the combination’s efficacy, in particular the duration of response, will need to be convincingly superior for it to substantially challenge Roche and Chugai/Daiichi Sankyo’s Zelboraf (vemurafenib), which for Roche generated 2012 sales of 234 million Swiss francs ($$259 million).