) recently announced disappointing data from a global phase III
study evaluating the use of Tykerb in patients suffering from
human epidermal growth factor receptor 2 (HER2) positive advanced
The randomized, multi-center, double-blinded, phase III study
compared the efficacy and tolerability of Tykerb as an adjunct to
) Eloxatin (oxaliplatin) and
) Xeloda (capecitabine) versus Eloxatin, Xeloda and placebo in
treatment naïve HER2-positive advanced gastric cancer patients.
Results from the study revealed that the treatment with Tykerb
did not cause significant improvement in overall survival (OS),
thus failing to meet the primary endpoint of the study. The
median OS was 12.2 months in the Tykerb plus Eloxatin and Xeloda
arm compared with 10.5 months for the Eloxatin, Xeloda and
Tykerb is currently approved in combination with Xeloda for
treating patients suffering from advanced or metastatic HER2
positive breast cancer who have received prior therapy including
an anthracycline, a taxane, and Roche's Herceptin. It is also
approved in combination with Femara (letrozole) for
postmenopausal women with hormone receptor positive metastatic
breast cancer that overexpresses the HER2 receptor.
We note that the company has received a string of blows in its
label expansion efforts pertaining to Tykerb including the
withdrawal of a marketing application for the drug in the US for
use in combination with Roche's Herceptin for the treatment of
patients with metastatic HER2 positive breast cancer who have
received prior Herceptin therapy.
The application was withdrawn in Jul 2012. The disappointing
data on Tykerb as a first-line therapy for the gastric cancer
indication is a further setback in this respect.
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We note that the pipeline at Glaxo must deliver to combat the
loss of revenues due to the generic competition faced by the key
products of the company.
Glaxo carries a Zacks Rank #3 (Hold). Companies that currently
look attractive include
), which carries a Zacks Rank #1 (Strong Buy).