ARTICLE | Clinical News

GSK's MAGE-A3 misses in Phase IIII NSCLC trial

March 20, 2014 11:58 PM UTC

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said intramuscular MAGE-A3 missed the co-primary endpoints of improving disease-free survival (DFS) vs. placebo in both the overall population and in patients who did not receive chemotherapy in the Phase III MAGRIT trial to prevent recurrence of non-small cell lung cancer (NSCLC) following surgery. Patients received up to 13 injections of MAGE-A3 over a period of 27 months. The double-blind, international trial enrolled 2,312 NSCLC patients whose tumors expressed the melanoma-associated antigen A3 (MAGEA3) gene.

GSK said it will continue MAGRIT until the third co-primary endpoint -- DFS in an undisclosed, predefined gene signature-positive subgroup -- is assessed. The data are expected in 2015, along with data for a gene signature-positive subgroup of MAGEA3-positive melanoma patients from a separate Phase III trial. In that trial, MAGE-A3 given after surgical removal of tumors missed the co-primary endpoint of improving DFS vs. placebo (see BioCentury Extra, Sept. 5, 2013). ...