Post by cenydd on Sept 5, 2013 12:38:17 GMT
GlaxoSmithKline’s cancer vaccine has failed to meet its first co-primary endpoint in a Phase III melanoma clinical trial.
The drugs giant notes that an independent analysis of the DERMA study of its MAGE-A3 cancer immunotherapeutic showed that it did not significantly extend disease-free survival in stage IIIB/C melanoma patients with macroscopic nodal disease, whose tumours expressed the MAGE-A3 gene when compared to placebo. The aforementioned gene is expressed in about 65% of stage III melanomas.
However GSK is not giving up and in line with the Independent Data Monitoring Committee’s unanimous recommendation, it 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 and the company noted that the IDMC raised no concern for the continuation of the trial. "We remain committed to identifying a patient sub-population who may benefit from this investigational treatment," said Vincent Brichard, head of immunotherapeutics at GSK Vaccines.
The drugs giant notes that an independent analysis of the DERMA study of its MAGE-A3 cancer immunotherapeutic showed that it did not significantly extend disease-free survival in stage IIIB/C melanoma patients with macroscopic nodal disease, whose tumours expressed the MAGE-A3 gene when compared to placebo. The aforementioned gene is expressed in about 65% of stage III melanomas.
However GSK is not giving up and in line with the Independent Data Monitoring Committee’s unanimous recommendation, it 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 and the company noted that the IDMC raised no concern for the continuation of the trial. "We remain committed to identifying a patient sub-population who may benefit from this investigational treatment," said Vincent Brichard, head of immunotherapeutics at GSK Vaccines.
www.pharmatimes.com/Article/13-09-05/GSK_cancer_vaccine_fails_first_part_of_melanoma_trial.aspx
Any potential devlopments in the treatment of cancer should be welcomed, of course, but this is a reminder that we are still a long way from finding that 'miracle cure'.