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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

Al's Comment:

 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.

 


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