Thanks Tuck,
I cannot say if pseudoprogression is occurring here, but survival apparently is. The evidence seems to show those on the drug are surviving longer once progression is diagnosed than those on the SOC do. I suspect they want more proof of this fact, thus they've lengthened the time until the final data is determined, but I hope that discussion with the FDA will lead to a way to file a BLA sooner than that.
I'm certainly no expert on pseudoprogression, I first learned the term on NWBO's site on another chat site. In the case of their Phase 3 Trial, it appears that many patients had pseudoprogression in GBM, I tend to think that they to may not meet goals set over a decade ago for the trial, but I believe survival will clearly say their vaccine should be approved. Of course nothing is certain, but the majority of the control group was crossed over to the vaccine and it's estimated that over 80 are still alive after at least 40 months post treatment, and many for years longer. I believe that nearly all remaining alive will have received the vaccine so the benefit should be clear. If you get a chance, take a look and let me know your thoughts about it.
As for IMGN, I'll wait and see what they're doing. They have a number of new technologies they're announcing at AACR, but frankly I hate the thought of waiting for their success if IMGN853 can't be approved. I still believe it will, but certainly the sales potential will be diminished unless in combination with other drugs it can benefit those who didn't receive sufficient benefit with it as a monotherapy. I still believe it has blockbuster potential, but it will take longer to achieve those sales.
Gary |
