GSK launches Phase III study to examine combined BRAF/MEK inhibition

GlaxoSmithKline (GSK) is to carry out a Phase III study to examine its combined BRAF/MEK inhibition in BRAF positive melanoma patients.

The company is to evaluate the mix of debrafenib and trametinib as a potential adjuvant therapy for melanoma, with the research hoping to determine whether a combination of the two can delay or prevent the disease's recurrence.

As part of the quantitative analysis, patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk cutaneous melanoma will be screened for eligibility.

These subjects will then be randomised to take either dabrafenib and trametinib combination therapy or two placebos for a year, with the study's primary endpoint set as relapse-free survival.

Research seeks to enrol about 850 subjects from over 200 investigative sites throughout the world.

Dabrafenib is an investigational, orally bioavailable inhibitor of the BRAF protein, while Trametinib is an inhibitor of the MEK proetein.

Two Phase II studies of combined dabrafenib-trametinib are ongoing in the metastatic BRAF V600 melanoma setting. (NCT01584648 and NCT01597908).

Dr Rafael Amado, head of oncology research and development for GSK, said: "The patients included in this trial are at high risk of their melanoma returning after surgery and there are currently few treatment options to reduce this risk.

"Given the efficacy and safety findings observed with combined dabrafenib-trametinib treatment in the metastatic setting, we are investigating whether the combination administered after surgery can help these patients live longer without melanoma recurrence."

Last month, GSK announced the submission of a regulatory application in the European Union for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI.

The drug is geared towards patients with chronic obstructive pulmonary disease and is a combination of two investigational bronchodilator molecules, GSK573719 and vilanterol.

The former is a long-acting muscarinic antagonist, while the latter is a beta2 agonist and is administered with the ELLIPTA inhaler.

Posted by Neil Clark