Glaxo Reports Disappointing Tykerb Data

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GlaxoSmithKline (GSK) 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 gastric cancer.

The randomized, multi-center, double-blinded, phase III study compared the efficacy and tolerability of Tykerb as an adjunct to Sanofi’s (SNY) Eloxatin (oxaliplatin) and Roche Holding’s (RHHBY) 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 placebo arm.

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The application was withdrawn in Jul 2012.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.

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 Santarus, Inc. (SNTS), which carries a Zacks Rank #1 (Strong Buy).

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