) 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
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)
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
). All these three companies carry a Zacks Rank #2 (Buy).
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