Data Safety and Monitoring Board Recommends Celldex`s Phase 3 Study of RINTEGA® (rindopepimut) in Newly Diagnosed Glioblastoma be Discontinued as it is Unlikely to Meet Primary Overall Survival Endpoint in Patients with Minimal Residual Disease
This is a huge shock. Celldex is stopping development of thier vaccine treatment for GBMs. Apparently, the patients in the control group did a lot better than they were expected to do. These patients all were EGFRvIII+, which would usually make them have a worse prognosis. In this trial, they compared the standard of care PLUS the vaccine, against the standard of care plus the drug KLH. KLH is an immunostimulant which is actually a part of the Celldex vaccine. The result was the control group has about a 21 month average survival for newly diagnosed. This compares to the results of the Novocure trial's control group which was the standard of care as well as a mix of other clinical trials and avastin - which yielded an average survival of 16.6 months. Perhaps more work needs to be done on KLH alone, and I still feel the Celldex vaccine is worthwhile. It still had a 20% improvement over historical controls and is a simple shot in the arm with minimal or no side effects, which may be a building block for a cocktail that actually works.
IF the story does not appear below, Click HERE to view the text of the story!
Note: The original website is displayed below - we have no control over it and are not responsible for the content of it, we just report it! IF you click on anything below, it will take you off of our website!
Original Source: http://ir.celldex.com/releasedetail.cfm?ReleaseID=959021
(Everything below this line is from VirtualTrials.com!)
Click HERE to return to brain tumor news headlines