Good DMC discussion. Thanks to gpb for the detailed description of what goes on. The holiday aspect could add 1-1.5 weeks to the normal window, taking it out to Feb 14.
Things that I hope inform the decision:
1. Immunotherapy is simply different from chemo in that the side effects are very very mild, so that there should be no safety concern that there is some toxicity that has not yet shown up and so resulting in a continue decision just for that.
2. The DCVax-L Phase III trial has an unusual element in that 33 patients were enrolled and treated 2006-2008, so there is data from that subset giving a long term view into results. This is unique in my experience. If the data from this blinded cohort back up the unblinded Phase I results, I would think that would be a very powerful indicator.
3. GBM is a very deadly, fast acting disease. The most recent GBM approval, Avastin, was approved with no improvement on PFS or OS; rather it had more benign side effects so was an improvement. So if the 33 patient cohort shows efficacy, even if not to the level of 6 mo PFS, I would think that would be a basis to get the vaccine to patients.
4. The 1st readout is at 60% of events, which is quite far along in the trial. Thus a chance to have good statistical significance exists.
5. We are well past DNDN and Provenge in the medical community both in terms of understanding and acceptance of immunotherapy and in terms of manufacturing of much a much more potent, lower cost, and easier to administer treatment.
Wrap all this together, and I think a powerful case could be made for early termination IF the data show a benefit.
News 
Market Data 
Discover 
AI
