Expression of defined genes identified by pretreatment tumor profiling: Association with clinical responses to the GSK MAGE- A3 immunotherapeutic in metastatic melanoma patients (EORTC 16032–18031)

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Abstract
9045 Background: Gene expression profiling by microarrays was used to identify markers predictive of the clinical activity of the MAGE-A3 Antigen-Specific Cancer Immunotherapeutic (ASCI) recorded in a phase II study in metastatic melanoma. Methods: 75 patients with progressive, unresectable stage III or stage IV M1a MAGE-A3 (+) melanomas, were randomized as 1st-line therapy between immunization with MAGE-A3 protein combined with GSK proprietary Adjuvant Systems AS15 or AS02B. Gene expression profiling was performed on tumor biopsies taken prior to any immunization. Results: Initial analysis using supervised hierarchical clustering of 2 objective responders (OR) with 7 non-responders identified 2 gene clusters based on differential expression. The correlation of this gene expression signature (GS) and objective response was further confirmed on 22 patients. Interestingly, mixed response (MR) and stable disease > 6 months (SD) clustered with OR, suggesting a strong association between the identified signatu...

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