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Glaxosmithkline Plc Announces That Investigational MAGE-A3 Antigen-Specific Cancer Immunotherapeutic Does Not Meet First Co-primary Endpoint In Phase III Melanoma Clinical Trial


Thursday, 5 Sep 2013 02:00am EDT 

Glaxosmithkline Plc announced that an independent analysis of the DERMAi study, a Phase III randomised, blinded, placebo-controlled trial of the MAGE-A3 cancer immunotherapeuticii showed that the study did not meet its first co-primary endpoint as it did not significantly extend disease-free survival (DFSiii) 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. The IDMC for the DERMA study indicated that the current review of the safety information raised no concern for the continuation of the trial.