GSK drops Phase III trial of MAGE-A3 antigen-specific cancer immunotherapeutic in NSCLC

UK pharma major GlaxoSmithKline (LSE:GSK) will stop its MAGRIT trial, a Phase III trial of its MAGE-A3 cancer immunotherapeuticin non-small cell lung cancer (NSCLC) patients, after failing to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the treatment.

Data from the trial announced on March 20 showed that it did not meet its first or second co-primary endpoints as it did not significantly extend disease-free survival (DFS) when compared to 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 continued with the MAGRIT trial to investigate the third co-primary endpoint of DFS in a gene signature positive sub-population, which was designed to identify a subset of MAGE-A3 positive patients that may benefit from the treatment. However, the pre-planned independent third-party analysis of a proportion of the data (to identify a gene signature classifier) has concluded that assessment of the third co-primary endpoint is not feasible due to an insufficient treatment effect.

The trial will be stopped and GSK will now gain access to the un-blinded data, in order to conduct a full assessment of the findings and understand learnings for other aspects of immunotherapy development within GSK.