Date: 2013-09-05
Type of information:
phase: 3
Announcement: results
Company: GSK (UK)
Product: MAGE-A3 antigen-specific cancer immunotherapeutic
Action mechanism: MAGE-A3 cancer immunotherapeutic consists of recombinant MAGE-A3 protein and a novel immunostimulant AS15 (a combination of QS-21 Stimulon® adjuvant, monophosphoryl lipid A, and CpG7909, a TLR-9 agonist, in a liposomal formulation). MAGE-A3 is a tumour-specific antigen that is expressed in a variety of cancers, including melanoma with no presentation in normal cells. MAGE-A3 is expressed in about 65% of Stage III melanomas.
Disease: melanoma
Therapeutic area: Cancer - Oncology
Country:
Trial details: The DERMA study is a double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 antigen-specific cancer immunotherapeutic as adjuvant therapy in patients with MAGE-A3 positive resected stage III melanoma.
Latest
news: * On April 2, 2014, Agenus has announced that GSK is continuing another Phase 3 clinical trial (DERMA) to evaluate whether a gene signature can identify a sub-population of melanoma patients that would benefit from the same investigational MAGE-A3 cancer immunotherapeutic. This follows the read-out of the first co-primary endpoint in September 2013 of disease free survival in the overall MAGE-A3 positive population, which was not met. Work is progressing on the mathematical model (the gene signature classifier) to allow assessment of DFSiii in the gene signature population, the second co-primary endpoint in the DERMA trial. The outcome is expected in 2015.
* On September 5, 2013, GSK has announced that an independent analysis of the DERMA study, a Phase III randomised, blinded, placebo-controlled trial of the MAGE-A3 cancer immunotherapeutic, showed that the study did not meet its first co-primary endpoint as it did not significantly extend disease-free survival (DFSiii) when compared to placebo in the MAGE-A3 positive population.The DERMA study evaluated the efficacy and safety of the MAGE-A3 cancer immunotherapeutic in Stage IIIB/C melanoma patients with macroscopic nodal disease, whose tumours expressed the MAGE-A3 gene and had their tumours removed surgically.
In line with the Inependent Data Monitoring Committee’s (IDMC) unanimous recommendation, GSK will continue the DERMA trial until the second co-primary endpoint is assessed. This endpoint, 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, GSK will remain blinded to all safety and efficacy data. The IDMC for the DERMA study indicated that the current review of the safety information raised no concern for the continuation of the trial. GSK has indicated that the company remains committed to identifying a patient sub-population who may benefit from this treatment. It is continuing to evaluate the same investigational MAGE-A3 cancer immunotherapeutic in another independent Phase III study (MAGRIT) in Non Small Cell Lung Cancer (NSCLC) following surgical removal of the primary tumour with first data anticipated in the first half of 2014.
