) recently announced disappointing data from the phase III DERMA
study on its MAGE-A3 cancer immunotherapeutic. The randomized,
blinded, placebo-controlled study evaluated the efficacy and
safety of the MAGE-A3 cancer immunotherapeutic in patients
suffering from stage IIIB/C melanoma with macroscopic nodal
disease, whose tumors expressed the MAGE-A3 gene. Moreover their
tumors were removed surgically.
An independent analysis of the DERMA study revealed that MAGE-A3
cancer immunotherapeutic did not significantly extend disease
free survival (DFS). The study failed to meet its first
co-primary endpoint. Investors have reacted negatively to the
The Independent Data Monitoring Committee (IDMC) recommended
continuation of the DERMA study until its second co-primary
endpoint is evaluated. Data related to the second co-primary
endpoint is expected in 2015.
We note that MAGE-A3 cancer immunotherapeutic is also being
evaluated for non small cell lung cancer following surgical
removal of the primary tumor. The first data from the study is
expected in the first half of 2014.
We are disappointed with the pipeline setback at Glaxo. The
biggest near-term challenge for Glaxo will be to replace the
revenues that will be lost to generic competition.
We believe that positive data from the DERMA study would have
supported regulatory filings and increased Glaxo's chances of
gaining approval for the MAGE-A3 cancer immunotherapeutic and
provided much needed boost to Glaxo's revenues.
Glaxo carries a Zacks Rank #3 (Hold). Companies that currently
look well-positioned include
Biogen Idec Inc.
) with a Zacks Rank #1 (Strong Buy) and
) with a Zacks Rank #2 (Buy).
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