GlaxoSmithKline announced that an independent analysis of the DERMA study demonstrated that the study did not meet the first co-primary endpoint of extending disease-free survival (DFS) with MAGE-A3 cancer immunotherapeutic when compared to placebo in the MAGE-A3 positive population.
The DERMA study is a Phase 3, randomized, blinded, placebo-controlled trial that evaluated the efficacy and safety of the MAGE-A3 cancer immunotherapeutic in 1,345 MAGE-A3 positive patients (those whose tumor shows expression of the MAGE-A3 gene) with Stages IIIB/C surgically resected melanoma. Patients were administered up to 13 injections into the muscle of the upper arm or thigh, over a period of 27 months.
MAGE-A3 is a tumour-specific antigen expressed in a variety of cancers, including melanoma with no presentation in normal cells. Cancer immunotherapeutics are designed to trigger a specific immune response against tumor cells expressing these proteins, by rallying antibodies and T-cells to recognize and attack the cancer cells in a highly specific manner and eventually eliminate them.
GSK’s MAGE-A3 cancer immunotherapeutic contains a purified recombinant MAGE-A3 protein combined with its AS15 adjuvant system to induce strong and sustained immune responses. Agenus’ adjuvant, QS-21 Stimulon, is a saponin extracted from the bark of the Quillaja saponaria tree and a component of GSK’s AS15 adjuvant system.
GSK will continue the study until the second co-primary endpoint is assessed. The Independent Data Monitoring Committee for the DERMA study indicated that the current review of the safety information raised no concern for the continuation of the trial.