MAGE A3 fails to meet endpoint in Phase III trial for NSCLC - GSK

Analysis of the MAGRIT trial, a Phase III trial of MAGE A3 cancer immunotherapeutic, from Glaxo Smith Kline, in Non Small Cell Lung Cancer (NSCLC) patients, showed that the trial did not meet its first or second co-primary endpoint as it did not significantly extend disease-free survival vs placebo in either the overall MAGE-A3 positive population (first co-primary endpoint) or in those MAGE-A3-positive patients who did not receive chemotherapy (second co-primary endpoint). GSK currently remains blinded to the overall trial data from the analysis of the first two co-primary endpoints to allow for the unbiased generation of a mathematical model to assess the third co-primary endpoint.

MAGRIT, a randomised, double-blind, placebo-controlled trial, is evaluating the efficacy and safety of the MAGE-A3 cancer immunotherapeutic in Stage IB, II and IIIA completely resected NSCLC patients whose tumours expressed the MAGE-A3 gene. Patients were given up to 13 intramuscular injections of either the MAGE-A3 immunotherapeutic or placebo over a period of 27 months. GSK will continue the trial in order to assess the third co-primary endpoint. Results from a final analysis are expected in 2015.