Astuprotimut-R: Phase III discontinued

GlaxoSmithKline stopped the double-blind, international Phase III MAGRIT trial in 2,312 stage IB, II or IIIA NSCLC patients whose tumors expressed the MAGEA3 gene after a pre-planned independent third-party analysis showed that there was an "insufficient treatment effect" of intramuscular MAGE-A3 given after surgical removal of a patient's tumors to assess the third co-primary endpoint of DFS vs. placebo in an undisclosed, predefined gene signature-positive subgroup. The third co-primary endpoint was designed to identify a subset of MAGEA3-positive patients that may benefit from treatment with MAGE-A3. Last month, GSK said the trial missed the co-primary endpoints of improving DFS vs. placebo in both the overall population and in patients who did not receive chemotherapy, but that the pharma would continue the trial until the third co-primary endpoint was assessed (see BioCentury, March 24). GSK will now gain access to the unblinded data. Patients received up to 13 injections of MAGE-A3 over a period of 27 months. ...