Date: 2014-04-02
Type of
information: Halting of the trial
phase: 3
Announcement: halting of the trial
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
Disease: non-small cell lung cancer patients
Therapeutic
area: Cancer - Oncology
Country: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Republic of Korea, the Netherlands, Norway, Poland, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, UK, USA
Trial
details: In the MAGRIT Program, patients were given up to 13 intramuscular injections of either the MAGE-A3 immunotherapeutic or placebo over a period of 27 months. GSK currently remains blinded to further details of the analysis of the first two co-primary endpoints in order to allow for the unbiased generation of a mathematical model to assess the third co-primary endpointiv, which is expected to be known in 2015. (
NCT00480025)
Latest
news:
- • On April 2, 2014, Agenus has announced that GSK MAGRIT study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3ii cancer immunotherapeutic trial in non-small cell lung cancer (NSCLC) patients, which contains Agenus’QS-21 Stimulon® adjuvant, will be stopped. GSK announced that it will not be possible to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the treatment. The Independent Data Monitoring Committee (IDMC) indicated that its review of the current safety information revealed no specific safety concern and the data is in line with the known safety information for the MAGE-A3 cancer immunotherapeutic.
- 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.
- • On March 20, 2014, Agenus has announced that GSK MAGRIT study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3i cancer immunotherapeutic trial in non-small cell lung cancer patients, which contains Agenus’QS-21 Stimulon® adjuvant, did not meet its first or second co-primary endpoint. The study did not significantly extend the disease-free survival (DFS)iii period when compared to placebo in the overall MAGE-A3 positive patients or patients who did not receive chemotherapy.
- GSK announced that it will continue the study until an analysis of the third co-primary endpoint is complete. The third co-primary endpoint is based on predefined criterion that was discussed with regulatory authorities. This analysis is based on gene signature and designed to prospectively identify MAGE-A3 positive patients who may benefit more from treatment. If further analysis shows that the predefined gene signature subset data are successful, there is the potential for regulatory filing. GSK anticipates that these data should be available in 2015. Until then, GSK will remain blinded to all safety and efficacy data. The Independent Data Monitoring Committee for the MAGRIT study indicated that a review of the safety information raised no specific concern for the continuation of the trial.
- GSK is also continuing to evaluate whether a gene signature can identify a population that would benefit from the same investigational MAGE-A3 cancer immunotherapeutic in DERMA, another Phase 3 trial in melanoma, which reported on the first co-primary endpoint in September 2013.
Is
general: Yes
