March 20, 2014
Glaxo’s Cancer Drug Faces Another Setback
Lee Rannals for redOrbit.com - Your Universe Online
The company said that the drug missed the first co-primary endpoints during the third phase of its study involving more than 2,000 lung cancer patients. The researchers found that the experimental therapy did not help patients live longer without their disease recurring.
During the study, patients were given up to 13 intramuscular injections of either GSK’s cancer drug or a placebo over a 27-month period.
“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,” Agenus, a biopharmaceutical company helping with the trials, said in a statement.
GSK said that it will continue studying until an analysis of the third co-primary endpoint is complete. This end-point will be based on predefined criterion that was discussed with regulatory authorities. According to the statement, the analysis is based on gene signature and was designed to identify MAGE-A3 positive patients who may benefit from more treatment.
“If further analysis shows that the predefined gene signature subset data are successful, there is the potential for regulatory filing,” Agenus said.
GSK says that data from this end-point will be available in 2015, and until then it will remain blinded to all safety and efficacy data.
“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,” Agenus said. “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.”
The company announced that the drug faced similar setbacks in melanoma patient trials back in September last year. GSK is planning to continue the clinical trials for melanoma patients with the drug as well.