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ARTICLE | Clinical News

MAGE-A3 Antigen-Specific Cancer Immunotherapeutic: Phase III data

September 9, 2013 7:00 AM UTC

The double-blind, international Phase III DERMA trial in 1,345 stage IIIB/C melanoma patients with macroscopic nodal disease whose tumors expressed the MAGEA3 gene showed that intramuscular MAGE-A3 given after surgical removal of a patient's tumors missed the co-primary endpoint of improving DFS vs. placebo. Patients received up to 13 injections of MAGE-A3 over a period of 27 months. Based on the recommendation of an independent DMC, GlaxoSmithKline said that it will continue the trial until the second co-primary endpoint is assessed. The endpoint, DFS in a gene signature-positive subgroup, is designed to identify a subset of MAGEA3-positive patients that may benefit from treatment with MAGE-A3. The subset data are expected in 2015. GSK said the data remain blinded and that it is still working to determine exactly how many gene signatures will be evaluated. ...