Lung cancer vaccine dropped
pharmafile | April 2, 2014 | News story | Research and Development, Sales and Marketing | GSK, MAGE-A3, NSCLC, Vaccine, lung cancer, magrit
GlaxoSmithKline took a hit today after its lung cancer vaccine MAGE-A3 failed to benefit patients.
The London-based firm has now stopped the Phase III MAGRIT trial, which was assessing the MAGE-A3 cancer immunotherapeutic in non-small cell lung cancer (NSCLC) patients.
It took this decision after establishing that it will not be possible to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the treatment.
Data from the trial announced on 20 March showed that the treatment 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 the overall MAGE-A3 positive population (the first co-primary endpoint).
It also showed it did not work in those MAGE-A3-positive patients who did not receive chemotherapy (the second co-primary endpoint).
Despite this setback, GSK had continued with the MAGRIT trial to investigate the third co-primary endpoint of DFS in a sub-population of patients to see if they could in fact benefit from the drug.
But this too has now failed after independent analysis showed it wasn’t feasible to continue due to an ‘insufficient treatment effect’.
Unlike traditional preventative vaccines, the MAGE-A3 treatment was designed for people with established disease, helping their immune systems to prevent the return of disease after surgery.
But the trial will now be stopped and GSK will 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”, according to the company.
There was one nugget of good news: the Independent Data Monitoring Committee revealed no specific safety concerns with the trial, although this will pose little comfort for GSK in the long term.
Vincent Brichard, senior VP and head of immunotherapeutics at GSK Vaccines, says: “We want to thank all patients, their families and healthcare workers for their involvement in this research.
“While we are extremely disappointed to learn that this trial did not have a positive outcome for the patients who participated in this trial, we are very grateful to its participants. We hope that the data generated in this trial will advance our understanding of the science of immunotherapeutics, and ultimately towards development of new therapies.”
A second trial testing the vaccine in the deadliest form of skin cancer melanoma, which also failed to help patients overall, will continue to investigate benefits in sub-populations, the firm adds.
Ben Adams
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