The latest news:

• NW Bio Provides Update About Phase 3 Trial Of DCVax®-L for Newly Diagnosed Glioblastoma Multiforme Brain Cancer        

  Very exciting news.  Nobody knows why the trial was placed on hold. Usually that is a bad sign but there are many reasons a trial can be placed on hold that have nothing to do with how good a treatment is.  See www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm .  I doubt it is for safety reasons, as there were no safety issues at all in the first few trials and in similar trials. That is the one we would worry about if it were true.  There are many other reasons. One possibility is that the FDA thinks that the trial will not prove anything.  There has been arguments back and forth about appropriate endpoints. At one time the FDA allowed progression free survival as an endpoint, but then the Avastin trial showed excellent progression free survival but no increase in overall survival, so the FDA changed its stance and said it wanted overall survival as an endpoint and that progression free survival is not enough. This happened after the trial was designed. The primary endpoint is progression free survival.  This trial allows patients in the control group to cross over and get the vaccine when they have a recurrence.  This messes up the endpoint of overall survival because you will be comparing people who get the vaccine to people who get the vaccine.  The FDA may think it is futile to try with the current design and may want the trial redesigned and done over again, which would probably be too expensive and lead to abandoning of the treatment.  I would protest that it is unethical to not allow cross over for the control group. (Let alone that it is unethical to have a control group in the first place).

     

  Anyway - this press release says they have stopped enrollment in the trial and will just analyze the results they have.  They already enrolled 331 patients, which should be enough to tell how it looks. IF it shows a progression free survival benefit, we will be fighting to get it approved based on this trial and hopefully not have to go through another phase 3 trial.
  




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• Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study of Onartuzumab Plus Bevacizumab Versus Placebo Plus Bevacizumab in Patients With Recurrent Glioblastoma: Efficacy, Safety, and Hepatocyte Growth Factor and O6-Methylguanine-DNA Methyltransferase Biomarker Analyses.         Unfortunately, the trial failed to show a benefit.
  



• First report of tumor treating fields use in combination with bevacizumab in a pediatric patient: a case report.         The FDA approval for Optune limited it to use in patients 22 and old because that was the youngest patient in the trial and it hasn't been tested on younger patients. Obviously, it should help younger people.  It can be prescribed for pediatric patients, off label, but insurance companies might try to reject it based on that FDA label restricting age.  Reports like this help us fight the insurance companies! I think the only real limit is the size of the head - the arrays are large and won't fit on a young child.
  

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