MAGE-A3 fails Phase III trial for Melanoma

An independent analysis of the DERMAi study, a Phase III randomised, blinded, placebo-controlled trial of the MAGE-A3 cancer immunotherapeutic, from GSK, showed that the study did not meet its first co-primary endpoint as it did not significantly extend disease-free survival (DFS) when compared to placebo in the MAGE-A3 positive population.

The DERMA study evaluated the efficacy and safety of the MAGE-A3 cancer immunotherapeutic 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 with no presentation in normal cells. MAGE-A3 is expressed in about 65% of Stage III Melanomas.

In line with the Independent Data Monitoring Committee�s (IDMC) unanimous recommendation, GSK will 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. Until then, GSK will remain blinded to all safety and efficacy data.