GSK Updates On MAGE-A3 Development In NSCLC
Espicom View : The use of immunotherapy as part of cancer treatment is a fast-growing and increasingly popular area. Despite this, advances in the cancer vaccine field have been slower than for other forms of immunotherapy and the historical pipeline is littered with failures. With drugs, increasingly companies have found success through the use of subgroup analyses of previously failed trials and in some cases, retrospectively bolting on a companion diagnostic to the development programme to pursue this avenue. However, as this latest development proves, this kind of reactive diagnostic use cannot always salvage a failing candidate and pharmaceutical companies are increasingly acknowledging the cost- and time-saving benefits of integrating diagnostics into their development plans from the start.
GlaxoSmithKline's MAGRIT, a randomised, blinded, placebo-controlled MAGE-A3 cancer immunotherapeutic Phase III trial in non-small cell lung cancer (NSCLC) patients, is to be stopped. GSK announced that it will not be possible to identify a subpopulation of gene signature-positive NSCLC patients that may benefit from the treatment.
The Independent Data Monitoring Committee indicated that its review of the current safety information revealed no specific safety concern and the data are in line with the known safety information for the MAGE-A3 cancer immunotherapeutic.
GSK is continuing another Phase III trial (DERMA) to evaluate whether a gene signature can identify a subpopulation of melanoma patients that would benefit from the same investigational MAGE-A3 cancer immunotherapeutic. This follows the read-out of the first co-primary endpoint in September 2013 of disease-free survival (DFS) in the overall MAGE-A3 positive population, which was not met. Work is progressing on the mathematical model (the gene signature classifier) to allow assessment of DFS in the gene signature population, the second co-primary endpoint in the DERMA trial. The outcome is expected in 2015.