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GSK’s MAGRIT trial fails to meet first co-primary endpoint

GlaxoSmithKline (GSK) has released results of the MAGRIT trial, a Phase III trial of its MAGE-A3 cancer immunotherapeutic in non-small cell lung cancer (NSCLC) patients.

The results showed that the trial did not meet its first or second co-primary endpoint 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).

The company 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.

The randomized, double-blind, placebo-controlled MAGRIT trial is evaluating the efficacy and safety of the MAGE-A3 cancer immunotherapeutic in Stage IB, II and IIIA completely resected NSCLC patients whose tumors expressed the MAGE-A3 gene.

In the trial, patients were given up to 13 intramuscular injections of either the MAGE-A3 immunotherapeutic or placebo over a period of 27 months.

MAGE-A3 is a tumor-specific antigen expressed in several cancers but not in normal cells.

In NSCLC, it is expressed in about one third of tumors in patients diagnosed with Stage IB-IIIA disease.

The MAGRIT trial enrolled 2,312 MAGE-A3-positive patients across over 400 sites in 34 countries worldwide.

The company said that Independent Data Monitoring Committee (IDMC) showed that its review of the current safety information raised no specific concern for the continuation of the trial and is in line with the known safety information for the MAGE-A3 cancer immunotherapeutic.

As planned, the company will continue the trial in order to evaluate the third co-primary endpoint, which is designed to identify a subset of MAGE-A3 positive patients that may benefit from the treatment with the MAGE-A3 cancer immunotherapeutic.

According to the company, results from a final analysis are expected to be released in 2015.

GSK Vaccines senior vice-president and head of Immunotherapeutics Vincent Brichard said, "We are disappointed that the trial did not demonstrate a benefit for overall MAGE-A3 positive patient population, but we remain committed to the effort to identify a sub-population of NSCLC patients who may benefit from this investigational treatment."