GlaxoSmithKline begins phase III trial to test the combination of BRAF inhibitors and MEK in patients with melanoma with mutation positive BRAF after surgery.

Spain, February 2013.- GlaxoSmithKline announces the start of COMBI-AD, a study phase III evaluates whether the combination of the two actors in research dabrafenib (a BRAF inhibitor) and trametinib (an inhibitor of MEK) as adjuvant therapy can delay or prevent relapse in patients with melanoma stage IIIa, IIIb or IIIc with V600K or positive BRAF V600E mutationhave been undergoing complete surgical resection. “The study also assesses the safety profile of the combination of dabrafenib-trametinib for this indication.

“The patients included in this study have high risk for a recurrence after surgery and there are currently very few treatment options to reduce this risk ”, says Dr. Rafael Amado, Director of GlaxoSmithKline Oncology r & d. “Once known the positive results of efficacy and safety with the combined treatment of dabrafenib and trametinib in metastatic melanoma, are now investigating whether this combination following surgery increases survival time without recurrence of the disease in these patients ”.

“Two studies are currently underway phase III evaluating the combination dabrafenib-trametinib in melanoma metastatic mutation BRAF V600 (NCT01584648 and NCT01597908).

COMBI-AD: Study 115532 (NCT01682083) is a phase III, randomized, double-blind, comparing the combination of BRAF inhibitor dabrafenib and MEK inhibitor trametinib facing two placebos as adjuvant therapy in melanoma after being subjected to surgical resection. The study will evaluate candidates to patients who have undergone complete resection, histologically confirmed, with positive mutation V600E BRAF/K and high-risk cutaneous melanoma [stage IIIa (with Sentinel lymph node metastases > 1 mm), IIIb or IIIc]. Patients will be randomized to receive the combined therapy of dabrafenib (150 mg twice daily) and trametinib (2 mg, once a day) or two placebos for twelve months. The primary objective of the study is the recurrence-free survival. The study hopes to recruit around 850 patients of more than 200 research centers from around the world.

About dabrafenib

Dabrafenib is an oral inhibitor in the BRAF protein research. GSK discovered and developed dabrafenib. In August 2012 registration applications were filed in the European Union and United States for dabrafenib as monotherapy for the treatment of melanoma metastatic mutation positive BRAF V600 (150 mg twice a day). Other applications are running.

About trametinib

Trametinib is an oral inhibitor in MEK protein research. Trametinib was discovered by Japan Tobacco. GSK has his license since 2006. In August 2012 was presented the application for registration in United States for trametinib as monotherapy for the treatment of melanoma metastatic mutation positive BRAF V600 (2 mg once a day). Applications shall be submitted in the coming months in the European Union and other regions.

GlaxoSmithKIine (GSK), one of the companies leading world pharmaceutical research and health care, aims to improve the quality of people’s life, enabling people to have more vitality, feel better and live longer.