Data Safety and Monitoring Board Recommends Celldex's Phase 3 Study of RINTEGAŽ (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.
