GlaxoSmithKline plc (GSK) has reported that an independent analysis of the DERMA study, a phase III randomised, blinded, placebo-controlled trial of the MAGE-A3 cancer immunotherapeutic, did not meet its first co-primary endpoint as it did not significantly extend disease-free survival (DFS) when compared to placebo in the MAGE-A3 positive population.
The DERMA study evaluated the efficacy and safety of the MAGE-A3 cancer immunotherapeutic in Stage IIIB/C melanoma patients with macroscopic nodal disease, whose tumours expressed the MAGE-A3 gene and had their tumours removed surgically. MAGE-A3 is a tumour-specific antigen that is expressed in a variety of cancers, including melanoma with no presentation in normal cells. MAGE-A3 is expressed in about 65 per cent of Stage III melanomas.
In line with the Independent Data Monitoring Committee’s (IDMC) unanimous recommendation, GSK will continue the DERMA trial until the second co-primary endpoint is assessed. This endpoint, DFS in the gene signature positive sub-population, is designed to identify a subset of MAGE-A3 positive patients that may benefit from the treatment. Results from this analysis are expected in 2015. Until then, GSK will remain blinded to all safety and efficacy data.
The IDMC for the DERMA study indicated that the current review of the safety information raised no concern for the continuation of the trial.
“We want to thank all patients, their families and healthcare workers for their involvement in the trial and we remain committed to identifying a patient sub-population who may benefit from this investigational treatment,” commented Vincent Brichard, senior vice-president & head of Immunotherapeutics, GSK Vaccines.
GSK is continuing to evaluate the same investigational MAGE-A3 cancer immunotherapeutic in another independent phase III study (MAGRIT) in Non Small Cell Lung Cancer (NSCLC) following surgical removal of the primary tumour with first data anticipated in the first half of 2014.
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