Recently, GlaxoSmithKline (GSK) announced the initiation of a phase III study (COMBI-AD) to evaluate its oncology candidate – dabrafenib. The study intends to evaluate dabrafenib, combined with trametinib, in patients suffering from melanoma.
The company intends to enroll approximately 850 patients from more than 200 sites across the globe for the randomised, double-blinded study. The study is designed to evaluate whether the combination therapy can delay or prevent the recurrence of melanoma in patients suffering from stage IIIa, IIIb, or IIIc BRAF V600E or V600K mutation-positive melanoma that has been removed via operation. Moreover, the study will also evaluate the safety profile of the combination of the two candidates.
Glaxo is also evaluating the combination of dabrafenib and trametinib in phase III studies in the metastatic BRAF V600 melanoma setting. We note that dabrafenib, as a monotherapy, is under review in the US and Europe for the BRAF V600 mutation-positive metastatic melanoma (150 mg once daily) indication.
Additionally, in Aug 2012, Glaxo submitted a new drug application to the US Food and Drug Administration (:FDA) for trametinib, as a monotherapy, for the BRAF V600 mutation-positive metastatic melanoma (2 mg once daily) indication.
We note that Glaxo has a robust pipeline. Multiple pipeline related news are expected in the coming quarters. We believe that Glaxo’s pipeline must deliver since many of its products are facing declining sales due to generic competition.
Glaxo carries a Zacks Rank #3 (Hold). Large-cap pharma companies that currently look better-positioned include Sanofi (SNY), Bayer (BAYRY) and Novartis (NVS). All these three companies carry a Zacks Rank #2 (Buy).
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