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A randomized, open label Phase II study designed to evaluate twodifferent formulations of the MAGE-A3 ASCI in patients with metastaticmelanoma has been conducted. In this study, the ASCI, which is a combinationof MAGE-A3 recombinant protein and a GSK proprietary Adjuvant System, wasevaluated and resultant data suggest a positive trend for clinical response.These data also demonstrate the induction of a desirable immune response,including humoral and cellular responses. These study results represent asecond positive trend for clinical activity for the novel MAGE-A3 cancerimmunotherapeutic, following encouraging clinical results reported in aseparate double-blind, placebo-controlled Phase II study of patients withNSCLC(4). The encouraging results from the Phase II NSCLC study have led to aPhase III safety and efficacy trial in MAGE-A3-positive NSCLC patients (stageIB, II and IIIA) who have undergone complete surgical resection (MAGRIT;MAGE-A3 Adjuvant Non-Small Cell LunG CanceR ImmunoTherapy).
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At this year's ASCO, GSK also presented data regarding the use of thegenetic profiling of melanoma in predicting clinical outcomes of treatmentwith MAGE-A3 ASCI. Biopsies performed on the melanoma tumors prior toimmunization were used to identify genetic markers expressed by the disease.These markers enabled researchers to establish a correlation between theexpression of given genes and the clinical response induced by the MAGE-A3ASCI in metastatic melanoma(2).
In addition, GSK presented data on the genetic profiling of patients withNSCLC. In a retrospective analysis, a predictive gene signature similar tothat observed in melanoma was associated with a lower rate of diseaserecurrence in the MAGE-A3 treated group(3).
"These phase II data mark another significant milestone for thedevelopment of the MAGE-A3 ASCI as a potential novel cancer therapy.Validation of a predictive gene signature, combined with selection ofpatients who express cancer antigens of interest, may allow GSK to improvepredictions of a patient's clinical response to treatment with cancerimmunotherapeutics," said Johan Vansteenkiste, Professor of InternalMedicine, Faculty of Medicine, Catholic University of Leuven, Belgium. "Theyalso provide further positive proof-of-concept Phase II data which highlightthe importance of the ongoing MAGRIT Phase III trial in Non-Small Cell LungCancer."
Phase II Melanoma Data: abstract # 9065(1)
A randomized, open-label Phase II study designed to evaluate MAGE-A3recombinant protein combined with two different Adjuvant Systems wasconducted. A total of 72 patients with measurable metastatic MAGE-A3-positivecutaneous melanoma (unresectable or in transit stage III or stage IV M1a)were randomized to receive immunization with MAGE-A3 protein combined witheither AS15 or AS02B as first-line metastatic treatment. Patients were toreceive a maximum of 24 immunizations over four years. Clinical activity isassessed by the RECIST criteria, the international standards for evaluationof solid tumors. Complete response (CR) and partial response (PR) i.e,disappearance or significant reduction of tumor, were reported in fourpatients in the AS15 group (3 CR and 1 PR) with two of these ongoing for morethan two years; in the AS02B arm, one patient showed a partial response whichlasted for 6 months.1 The safety profile was similar in both groups with themajority of reported adverse events bei
