So that means a relatively small number of patients would be needed on the regulatory path. Second, there is a very clear unmet need. There is an established benchmark for what ibrutinib looks like in monotherapy in primary CNS lymphoma, ibrutinib attained a 19% CR rate. And then third, it really is going to establish what I hope to be a nice opportunity for us to demonstrate first, whether we can be an additive benefit, can we increase the CR rate by adding our drug to ibrutinib. But also, can we get CRs in patients who have progressed on BTK treatment. Can they be resensitized? That has always been the hypothesis for emavusertib and IRAK4 inhibition this will be the first time we can see data to see whether or not that’s possible. So that would be my expectation for reviewing the data at ASH.
Leukemia is a 2024 story. The ASH story is going to be lymphoma.
Yale Jen: Okay. Great. That’s helpful. And the second question here is that you have mentioned earlier that before that high risk and MDS development will depends on what you see — what the sort of standard of care potentially could be established, so you will set after for doing that and what’s your current thoughts in terms of that aspect.
Jim Dentzer: No, that’s exactly right. So and by standard of care, as you know, the standard of care in AML is the azacitidine and venetoclax doublet. Today as we stand, the standard of care in MDS is azacitidine monotherapy. The azacitidine venetoclax study is still pending. That’s the VERONA study. And those results presumably are imminent. So we’re waiting to see, of course, is if that study is positive or negative, if that study is positive, and the doublet is also the standard of care in MDS we will want to proceed with a triplet. If on the other hand, it’s negative and azacitidine remains as monotherapy is the standard of care, then we would look to proceed with the doublet. Is that helpful?
Yale Jen: Oh, absolutely.
Jim Dentzer: Great.
Yale Jen: That’s very, very helpful. And maybe what — any timeline you can sort of, speculate at this point?
Jim Dentzer: We don’t run that study. So unfortunately, no, I mean, I think what the broader world is expecting is that it’s sometime over the next few months, whether that’s ASH or sometime in early 2024. Of course, we don’t know any more than you do, but we are eagerly awaiting the outcome of those data.
Yale Jen: Okay, great. That’s very helpful. And again, congrats on the progress. I look forward to seeing that.
Jim Dentzer: Thank you very much, Yale.
Operator: Your next question comes from Lee Warwick from Cantor Fitzgerald. Lee, please go ahead.
Q – Unidentified Analyst: Hey, good morning. Thanks for taking our questions. Jim, maybe can you just frame the expectations for us a little bit for the data update in first half of next year, particularly in AML and MDS, what the bar will be?
Jim Dentzer: Yes. So in AML and MDS it’s going to be separate, right? So we are proceeding with monotherapy in patients in the relapse refractory setting for FLT3 and spliceosome patients. And MDS, as Yale asked about, we’re really awaiting news of the VERONA study to make sure we understand the path forward. In FLT3 and spliceosome, the benchmarks are pretty clear. FLT3 CR rate with GILTEritinib, and GILTEritinib, as you know, is the market leader for FLT3 inhibitors, is 12%. So, of course, we would want to improve on that. Their CR-CRH rate was 22.6%. And, of course, we would want to improve on that. In spliceosome patients, it’s not clear that there are any treatments capable of getting a CR rate. As far as I know, there’s never been anything published.
