Cory William Kasimov - JP Morgan Chase & Co, Research Division
Q : First, you said the ASPIRE interim is now anticipated in the fourth quarter of 2013 or later. I guess, do you have a sense of why events are accruing slower than expected? Or maybe asked another way, how consistent is the PFS data for the Rev/dex combination in this setting in the literature?
Second, on dosing and for Kyprolis, and I'm wondering if you're finding in the real world, if docs are sticking to the initial label or pushing to doses that you're using in some of these ongoing clinical studies?
A : Barbara Klencke
Yes, we are tracking later than anticipated. These are event-driven analysis, so highly dependent on the rate of progression. But only information we have is the pooled information, so we cannot speculate as to the reason. As you mentioned, the Rev/dex literature has been published. We used in our initial projections the data that's been presented in New England Journal. And it could -- we basically are going to continue to look at event progression rates over time. The FOCUS data is a survival end point. And as we've completed enrollment, we're now looking forward to the next milestone, which is interim data. So we also talked today about the survival data being available in the second half of 2013 based on an interim analysis for that study.
And I think, Cory, and everyone else, this is just reflective of what happens with event-based trials. We are encouraged with the possibility of FOCUS data potentially early on the basis of an interim readout.
Helen I. Torley
Dosing and actually the general use of Kyprolis, what we're seeing is it's predominantly being used according to our label indication. So the dose is according to the label starting at 20 and titrating to 27. And the population that is being studied are patients who have previously received bortezomib and an IMiD and who are progressing on or within 60 days of their last therapy.