New Data on MAGE-A3 Cancer Immunotherapy Support Potential Novel Options of Treating Non-Small Cell Lung Cancer an...(safetyprofile was similar in both groups...),Health

Gene Profiling in Melanoma: abstract # 9045(2)

Gene expression profiling by microarrays was used to identify markers predictive of the clinical activity of the MAGE-A3 ASCI recorded in the phase II melanoma study. Gene expression profiling was performed on tumor biopsies taken prior to any immunization, leading to the identification of a gene signature which reflects a specific immune micro-environment present prior to any therapeutic intervention. This gene signature seems to be strongly associated with MAGE-A3-induced clinical responses(2).

Gene Profiling in Non-Small Cell Lung Cancer: abstract # 7501(3)

These data show that it may be possible to identify patients that present a high or low risk of relapse after surgery. A gene signature similar to that observed in melanoma was associated in a retrospective analysis with a lower rate of disease recurrence in the MAGE-A3 treated group. Another signature that is predictive to clinical activity of the MAGE-3 ASCI treatment, which increased clinical activity by a factor of 2, was also described(3).

This specific set of data follows the proof of concept Phase II data that GSK reported at ASCO in 2007, which showed a 27% reduction in the relative risk of NSCLC recurrence following surgery in patients treated with the MAGE-A3 ASCI, compared to placebo(4). In the patients population selected for the presence of the predictive gene signature, a 43% reduction in the relative risk of relapse was observed(3). (Data on file).

Based on these encouraging data in NSCLC, GSK has initiated patient recruitment to a randomized and controlled Phase III efficacy and safety trial (MAGRIT) for this novel cancer immunotherapy. MAGE-A3 ASCI will be evaluated as adjuvant therapy in about 2,270 MAGE-A3-positive patients with completely resected stage IB, II or
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