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ARTICLE | Clinical News

GSK's MAGE-A3 misses in Phase III melanoma trial

September 5, 2013 11:48 PM UTC

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said intramuscular MAGE-A3 given after surgical removal of a patient's tumors missed the co-primary endpoint of improving disease-free survival (DFS) vs. placebo n the Phase III DERMA trial to treat melanoma-associated antigen A3 ( MAGEA3)-positive, resected melanoma. Based on the recommendation of an independent DMC, GSK said it will continue the trial until assessing the second co-primary endpoint -- DFS in a gene signature-positive subgroup, which 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. The double-blind, international trial enrolled 1,345 stage IIIB/C melanoma patients with macroscopic nodal disease whose tumors expressed the MAGEA3 gene.

Data from the Phase III MAGRIT trial of MAGE-A3 to treat non-small cell lung cancer (NSCLC) following surgical removal of the primary tumor are expected in 1H14. MAGE-A3 is a cancer vaccine consisting of recombinant MAGEA3 protein and the AS15 immunostimulant. The AS15 adjuvant is a liposomal formulation of the QS-21 Stimulon adjuvant from Agenus Inc. (NASDAQ:AGEN) in combination with monophosphoryl lipid A and CpG7909 (PF-3512676), a toll-like receptor 9 (TLR9) agonist that Pfizer Inc. (NYSE:PFE) discontinued development of in 2010. ...