We will be presenting the DETERMINATION study which is our randomised comparison between lenalidomide bortezomib and dexamethasone, the so-called RVd, with either early or delayed transplant. But in our presentation we’re going to also be talking a little bit more about some of the issues around second primary malignancies and the outcomes in some of our patients who, although small in number, developed hematologic malignancies and what their outcomes were. We’re also obviously focussing on some aspects of the original primary data presented at ASCO including duration of response, quality of responses and what happened to our MRD negative patients. So that, in terms of DETERMINATION, is something a little different.
Having said that, we’re going to focus on the key findings – improvement in progression free survival of 21.4 months for early transplant versus delayed, the real impact of lenalidomide maintenance until progression, which is a key point. That’s the real takeaway from the study was that the importance of lenalidomide given continuously until progression resulted in the best outcomes we’ve seen for both arms.
Then just a further examination of in the delayed transplant arm the fact that only 28% of those patients received delayed transplant to date, the multitude of other novel therapies that were used, and that’s obviously very important to understand because at the end of the day we have the same overall survival. What’s important to note is that in our salvage therapies more of the patients on the transplant arm actually received antibodies compared to those on the delayed transplant arm which is interesting because there had been speculation – is it the antibodies making the difference to bring back survival for the RVd alone or transplant delayed arm? In fact, there’s almost twice as much antibody use on the transplant arm than there is on the delayed transplant arm. So that in itself doesn’t explain the fact that the median survivals are the same.
So it may be that we need more time, and that’s certainly true. However, the interval stability in the numbers suggests that there may be other factors at play and that’s obviously going to be, hopefully, an important point for discussion.