And Bill, to your point about the activity and the activate study thus far, I’ll just point out that patients began enrolling and APTIVATE in January. It takes a month before their first assessment takes — preliminary marrow assessment takes place, and then another month before the confirmatory biopsy takes place. So we’re just about at that point now for the earliest patients enrolled. So all we can really say is that we’ve observed activity in terms of peripheral blast productions and looking at early looks at the bone marrow only, but we’ll have more data around that as you get further along.
William Rice: So, Rosemary, did we answer your questions?
UnidentifiedAnalyst: Thank you.
William Rice: All right. Thanks for coming on.
Operator: Our next question comes from the line of Gregory Renza with RBC. Your line is open.
UnidentifiedAnalyst: Hi guys, it’s Anish on for Greg. Congrats on the progress and thanks for taking my question just on TUS and considering the different AML mutations or subpopulation studied and with the data to date and which type are you seeing the most responses? And as a follow up in which subtype are you seeing greater response with a 40 milligram dosing regimen versus those that require greater exposure/higher dose for a response with tests? And how might these findings inform regulatory next steps? Thanks so much.
William Rice: Yeah, good question. But Rafael, do you want to jump in on this one?
Rafael Bejar: Yeah, I can, start that. That is a great question. I think that that is something that we’re very interested in learning. We’re limited by a few things. First is patient numbers, but even after treating 60 plus patients, you don’t necessarily have that many patients in any particular genetic subgroup when you open a study to all comers. So we don’t have large denominators with which there be highly accurate about our response rate, but we do see activity in these patients that have these mutations that we would like to have activity against, including NARs. We’ve again, seen two patients with TP53 mutations that have activity. These are all patients that are predicted to not do as well because of these adverse mutations that they carry.
It could be subsets of populations with greater medical need, but to be fair, all relapse refractory AML patients are a population of great unmet medical need as many — can’t be cured as conventional therapy, they need to go to some sort of stem cell transplant at that point. So the ones of interest, I think I mentioned NRAs TP53 FLT3 patients that have exhausted for three inhibitors prior, but there may be others, and it may be combinations of mutations that matter, for example, MPM1 and FLT3 mutations, we’ve seen a reasonable response rate in that patient population as well. In the APTIVATE study by enrolling additional patients will really give us the confidence that we understand what those response rates are to different populations. You had asked about differential activity, the 40 milligram dose level.
We’ve reported that there were two responses at that dose level. So again, very small numbers, not really enough to discriminate whether, 40 was enough for some patients, but not enough for others. I think we’ll have to really look at the DK more to define what the optimal dose is there, even though we’re thrilled to see activity at the 40 milligram dose level.
Operator: Our next question comes from a line of John Newman with Canaccord. Your line is open.
John Newman: Hi guys, thanks for taking the question. I was wondering as you move forward with the APTIVATE study in terms of the potential for accelerated approval, would you expect that you’ll be focusing on a specific mutational type or would you be focusing more broadly? Thanks.
