5th Sep 2013 08:59
LONDON (Alliance News) - GlaxoSmithKline Plc. (GSK, GSK.L) Thursday said an independent analysis of a late-stage study, DERMAi, showed that the study did not meet its first co-primary endpoint as it did not significantly extend disease-free survival compared to placebo in the MAGE-A3 positive population.
The DERMAi study was a Phase III randomized, blinded, placebo-controlled trial of the MAGE-A3 cancer immunotherapeutic. It evaluated the efficacy and safety of MAGE-A3 in Stage IIIB/C melanoma patients with macroscopic nodal disease. Tumors of these patients expressed the MAGE-A3 gene and had their tumors removed surgically.
MAGE-A3 is a tumor-specific antigen that is expressed in many cancers, including melanoma with no presentation in normal cells. MAGE-A3 is expressed in about 65 percent of Stage III melanomas.
The pharmaceutical giant said it would continue the DERMA trial until the second co-primary endpoint is assessed, in line with the Independent Data Monitoring Committee's or IDMC unanimous recommendation.
This endpoint of 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, the company will remain blinded to all safety and efficacy data.
The IDMC indicated that the current review of the safety information for the DERMA study raised no concern for the continuation of the trial. Vincent Brichard, senior vice-president & Head of Immunotherapeutics, GSK Vaccines, said, "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." GSK continues to evaluate the same investigational MAGE-A3 cancer immunotherapeutic in another independent Phase III study, MAGRIT, in Non Small Cell Lung Cancer following surgical removal of the primary tumor. Its first data is expected in the first half of 2014.
GSK.L is down 0.5 percent in early morning trade at 1,658 pence.
Copyright RTT News/dpa-AFX
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