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GSK’s Tyverb/ Tykerb disappoints in gastric cancer trial

Fails to improve overall survival in proposed new indication

GSK Tyverb lapatinib oncology

GlaxoSmithKline's (GSK) intentions to expand the indication of personalised cancer drug Tyverb/ Tykerb took a blow when it failed to hit its target in a late-stage trial investigating its use in the treatment of gastric cancer.

The pharma company said that when used in combination with chemotherapy, the drug did not meet its primary endpoint of improved overall survival compared to chemotherapy alone in patients with an HER2-positive advanced form of the condition.

The difference in median overall survival between the two arms was just 1.7 months in favour of patients on Tyverb/ Tykerb (lapatinib).

These results damage GSK's prospects for the drug, which is known as Tyverb in Europe and Tykerb in the US, although the company did not say whether it intended to pull investigation in this indication.

This isn't the first time that GSK has received disappointing news in its attempts to expand the use of Tyverb/ Tykerb, which is approved in both the US and EU as combination therapy with capecitabine or an aromatase inhibitor to treat patients with advanced breast cancer that express large amounts of the protein HER2.

GSK has previously announced that Tyverb/ Tykerb had missed its endpoint in a trial investigating its use on early-stage HER2-positive breast cancer patients.

In July 2012, the company withdrew a marketing application in the US for the drug's use in combination with Roche's Herceptin (trastuzumab) in patients with HER2-positive metastatic breast cancer who have received prior Herceptin therapy, while in February 2012, a European application for use of the drug in combination with paclitaxel in breast cancer was also pulled.

There are still other prospects for Tyverb/ Tykerb, however, and it is currently under investigation for use in the treatment of squamous cell carcinoma of the head and neck.

4th June 2013

From: Research

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