kruk8146 • 13 minutes ago Flag
yaba- My speculation on the primary endpoints having been met is just that, speculation really. I only base it on the facts that we have at our disposal, and there are many supporting facts if one digs deep enough. For instance, I feel very assured by the fact that Ph III only needs to achieve 1/3 the median PFS of the Ph I/II trial. If IMUC's ICT-107 was able to achieve 3 mos PFS increase in 117 of the124 patients in its Ph II trial, then DCVax-L should easily be able to double that as it is a much more sophisticated DC therapy. I also find the long tail of survival from the Ph I/II patients very encouraging with 33% alive 4 yrs, 27% alive 6 years, 2 pts alive 10 yrs. Additionally, 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. Also, 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. If the data from this blinded cohort back up the unblinded Phase I results, I would think that would be a very powerful indicator.
As far as not enough statistical powering, I was suggesting that there while the primary endpoints might have been met, the data is not mature enough, and waiting till the 2nd interim would provide more mature data, which would help bolster chances at FDA approval. It's possible the DMC already recommended approval but the NW steering committee has chosen to wait for more statistical powering to increase their odds of approval. Sorry if that sounded repetitive. Running off a few hours sleep and starting to nod off!
As far as the Sept 2014 completion date. That was just an estimate. It's been pushed further out over the past few years and the latest estimate is late 2014 to mid-2015.
