GSK cancer vaccine fails in Phase III
pharmafile | September 5, 2013 | News story | Research and Development, Sales and Marketing | BMS, GSK, Yervoy, melanoma, phase III
GlaxoSmithKline’s hopes of creating a cancer vaccine against the deadliest form of skin cancer took a blow today when its treatment failed to beat placebo in a late-stage study.
The Phase III DERMA study, which was assessing the London firm’s MAGE-A3 cancer immunotherapeutic, showed the drug did not meet its first co-primary endpoint of significantly extend disease-free survival (DFS) when compared to placebo.
The trial was looking at the efficacy and safety of the MAGE-A3 cancer treatment in stage IIIB/C melanoma patients with macroscopic nodal disease, whose tumours expressed the MAGE-A3 gene and had their tumours removed surgically.
MAGE-A3 is a tumour-specific antigen that is expressed in a variety of cancers, including melanoma; it is believe this antigen is expressed in about 65% of stage III melanomas.
GSK said it would continue the DERMA trial until the second co-primary endpoint is assessed. This endpoint, DFS in the gene signature positive sub-population, is designed to identify a subset of MAGE-A3 positive patients that may benefit from the treatment.
Results from this analysis are expected in 2015 but until then, GSK will remain blinded to all safety and efficacy data, it said in a statement.
Vincent Brichard, senior VP and head of immunotherapeutics at GSK vaccines, said: “We want to thank all patients, their families and healthcare workers for their involvement in the trial and we remain committed to identifying a patient sub-population who may benefit from this investigational treatment.”
GSK added that it is continuing to evaluate the drug in another Phase III study, known as MAGRIT, in non-small cell lung cancer following surgical removal of the primary tumour. First data from this trial is expected early next year.
GSK is hoping to compete with Bristol-Myers Squibb which launched the world’s first melanoma vaccine, known as Yervoy (ipilimumab) in 2011.
The drug has seen impressive sales, reaching $706 million last year, with projections that it could hit more than $2 billion in peak sales by 2018.
Given the success of BMS’ drug, analysts are predicting blockbuster sales for GSK’s new treatment, should it reach the market.
GSK already has two melanoma treatments on the market: Tafinlar and Mekinist which both target particular genetic mutations, and are expected to have combined peak sales of more than $1 billion.
Ben Adams
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