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Setback for GSK as melanoma vaccine misses targets

Cancer immunotherapy disappoints in phase III

GSK GlaxoSmithKline house

GlaxoSmithKline's (GSK) melanoma vaccine skidded of course this week after the drug missed its target in the first of three phase III trials.

The therapeutic vaccine for melanoma was unable to significantly extend disease-free survival (DFS) compared to placebo in the DERMA study, which involved 1,300 stage IIIB/C melanoma patients whose tumours express the MAGE-A3 antigen.

The company said it will continue the study until it reaches a second primary outcome measure, which will look at DFS in a subset of MAGE-A3-positive patients that the company believes may be particularly responsive to treatment with the vaccine. No safety issues were identified in the trial.

MAGE-A3 is a tumour-specific antigen expressed in a variety of cancers and is seen in around two-thirds of advanced melanoma cases. GSK noted that a phase III trial of its immunotherapy in 2,270 patients with non-small cell lung cancer (NSCLC) - called MAGRIT - should also deliver data in early 2014.

"We remain committed to identifying a patient sub-population who may benefit from this investigational treatment," said Vincent Brichard, head of immunotherapeutics at GSK's vaccines unit.

Analysts at Panmure Gordon are not writing off the project just yet and retain sales forecasts of £100m in 2015, rising to £250m at peak, although they note the project is "very high risk because it is in an unproven area".

GSK "has had the confidence to invest in its pipeline at a time when the market was expecting a focus on margins," according to the analysts, who retain a positive view on the company, in which they took an opening stake at the end of last year.

"It is too early to get too excited about possible blockbusters in the company's pipeline, but it has lined up a number of shots at goal - perhaps as many as 14 of them," they add.

The news comes amid a run of setbacks for companies trying to develop cancer vaccines. The first such product to reach the market - Dendreon's prostate cancer therapy Provenge - reached the market but has seen its sales stall, while Merck KGaA's L-BLP25 candidate for NSCLC failed to meet targets in a phase III trial earlier this year.

Meanwhile, news of the disappointing DERMA data hit shares of Agenus, which is developing one of the immune-stimulating adjuvants used alongside the MAGE-A3 antigen in GSK's vaccine.

Shares in the US company fell by almost a third on the news, although GSK's stock was largely unmoved as most investors consider the programme a 'wild card' for the company.

Article by
Phil Taylor

6th September 2013

From: Research

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