ARTICLE | Clinical News

Astuprotimut-R: Phase III data

March 24, 2014 7:00 AM UTC

The double-blind, international Phase III MAGRIT trial in 2,312 stage IB, II or IIIA NSCLC patients whose tumors expressed the MAGEA3 gene showed that intramuscular MAGE-A3 given after surgical removal of a patient's tumors missed the co-primary endpoints of improving DFS vs. placebo in both the overall population and in patients who did not receive chemotherapy. Patients received up to 13 injections of MAGE-A3 over a period of 27 months. GlaxoSmithKline said it will continue the trial until the third co-primary endpoint is assessed. The endpoint, DFS in an undisclosed, predefined 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. Additionally, an independent DMC said that a review of safety data raised no specific concern for continuation of the trial. ...