Today, GlaxoSmithKline (GSK) announced that its cancer vaccine MAGE-A3 failed to meet its two primary endpoints in a late stage trial.
The company said that its Phase III MAGRIT trial, evaluating its MAGE-A3 cancer immunotherapeutic in non-small cell lung cancer (NSCLC) patients, 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, which was the first co-primary endpoint, or in those MAGE-A3-positive patients who did not receive chemotherapy, which was the second co-primary endpoint.
The company intends to continue the trial in order to assess the third co-primary endpoint, designed to identify a subset of MAGE-A3 positive patients that may benefit from the treatment with the cancer vaccine. Results from a final analysis are expected in 2015.
MAGE-A3 is a tumor-specific antigen expressed in several cancers but not in normal cells. The antigen is expressed in approximately one third of tumors in patients diagnosed with Stage IB-IIA NSCLC. The vaccine is unlike traditional preventive vaccines. It is designed for people with established disease, helping their immune systems prevent the return of disease after surgery.
“We want to thank all patients, their families and healthcare workers for their involvement in the MAGRIT trial. 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,” said Vincent Brichard, Senior Vice-President & Head of Immunotherapeutics, GSK Vaccines.
GSK had a similar setback in September, when its drug did not extend disease-free survival in melanoma patients when compared to placebo in mid-stage trials. The company will continue to evaluate the vaccine in another Phase III clinical study DERMA to determine if a sub population of melanoma patients would benefit from MAGE-A3.
Source: GlaxoSmithKline plc
Last updated: 3/20/14; 12:30pm EST