GSK cancer vaccine misses target in melanoma trial

Drug is also being tested for use in treating lung cancer

Blow GlaxoSmithKline in high-risk, high-reward project. Photograph: Simon Dawson/Bloomberg
Blow GlaxoSmithKline in high-risk, high-reward project. Photograph: Simon Dawson/Bloomberg

An experimental cancer vaccine from GlaxoSmithKline failed to meet the first of two joint targets in a closely watched late-stage clinical trial, dealing a blow to the high-risk, high-reward project.

Britain’s biggest drugmaker said it would continue with the Phase III trial of its MAGE-A3 therapeutic vaccine until the second of the targets, known as co-primary endpoints, is assessed.

The vaccine is one of two particularly high-risk developmental GSK products believed by analysts to have the potential to become multibillion-dollar sellers. The other is a heart drug called darapladib, designed to fight clogged arteries in a different way to statins.

Unlike traditional preventative vaccines, MAGE-A3 is meant to treat people with established disease, where it is supposed to help their immune systems to fight back. It is also being tested in lung cancer.

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Other companies have had some recent notable success in clinical trials with innovative drugs to boost the immune system, but GSK is still pushing the scientific boundaries with MAGE-A3.

GSK’s vaccine was developed for use in patients with tumours that express the cancer-related MAGE-A3 gene, which occurs in about 65 per cent of Stage III melanomas.

It failed to significantly extend disease-free survival when compared with placebo in this population in the Phase III study.

The second endpoint of the trial is to see whether disease-free survival is improved in a subset of MAGE-A3-positive patients. Results from this analysis are expected in 2015.

GSK added that no safety issues had emerged in the trial.

“We remain committed to identifying a patient sub-population who may benefit from this investigational treatment,” said Vincent Brichard, head of immunotherapeutics at GSK Vaccines.

GSK is also continuing to study MAGE-A3 in another Phase III study against non-small cell lung cancer. The first data from this trial are expected in the first half of 2014. (Reuters)