Ashiq Mubarack: Got it. That’s very helpful color. And if I could squeeze in one more. I guess, what are the gating factors for filing the INDs for your leading preclinical assets? I guess where are you in IND enabling studies, especially for 191 and 171? I’m just wondering if you can give us a sense of how much work is left before you can enter the clinic.
Ken Galbraith: Yes. Those are both on target for 2024 as we stated. We haven’t given more guidance than that yet. We may give some more guidance as we move into 2024. But you’re more likely just to see a clinical study up on clinical trials and an indication that we’re recruiting patients along the way. So I think we’re in really good shape with where we’re at. I think you’ll have to wait for more guidance next year, early next year, or just wait for some events, which shows we’re actually recruiting patients on both those studies.
Ashiq Mubarack: Got it. Thanks very much.
Operator: Thank you. [Operator Instructions] Our next question comes from Charles from Guggenheim Securities.
Charles Zhu: Hey, good evening, guys, or good afternoon, guys. And thanks for taking the question. Maybe one from me with a bit more of a nearer-term focus and regarding zanidatamab, some of those milestones coming up next year, a couple of ones here. Any reactions to the KEYNOTE-811 data from ESMO, as well as from I believe it was the European review and how that sets a bar for HERIZON-GEA. And as well as similar to that, we do have the I guess the headline figures on some of those near-term milestones from Jazz as well as BeiGene related to zanidatamab milestones in 2024. But could you also perhaps quickly remind us like how much of that could be accounted for with BTC and GEA? Thank you.
Ken Galbraith: No, thanks for the question or a couple of questions that you sneak in there one question. Thank you. No, I think for guidance on those two programs, we’ll defer to both Jazz and BeiGene. I know Jazz has their earning call tomorrow, so in terms of what guidance they’d like to provide, we’ll let them make that. Obviously, in the arrangement we have with Jazz, we have $525 million in development milestones remaining on that deal based on approval of zanidatamab and different geographies and different indications. I don’t think we can say any more than that, other than that’s a pretty reasonable milestone payments in a time period. But I think would be really helpful for us to continue to fund both the 5/5 portfolio further in the clinic, as well as see the additional R&D we’d like to do.
With advance, I think beyond that, we’ve been following KEYNOTE-811 since the study started, and we’ve been 12 or so months behind that study. I think it’s safe to say from the data that was available at ESMO and before that in the European review is that I think the commercial opportunity for zanidatamab to be the standard of care in the first line GEA patients, regardless of PD-L1 status, but also with the possibility of being used in combination with chemo and potentially a PD-1 is better than we’ve seen, I think better than we thought it might have been 12 months ago. So I think there’s obviously a stronger commercial opportunity. I think we and our partners are anxious to get to that point. So we’re really looking forward to getting the top line data from our study next year, which is still on target, and then sharing that data with regulators to understand on the earliest opportunity that we could make this therapy available for patients based on that data outcome.
So it’s always hard to have a substantial competitor 12 or more months ahead of you in this marketplace. But I think given the data that we’ve seen so far, and what we continue to see from zani, we’re very optimistic and more optimistic about the potential uses of zani in this patient population, the potential benefit we could provide to these patients, and therefore the commercial opportunity being pretty exciting for ourselves and our partners, as well as for patients.
Charles Zhu: Great. Thank you.
Operator: Thank you. [Operator Instructions] And our next question comes from Akash from Jefferies.
Ivy Wang: Hi, this is Ivy on for Akash. Thanks for taking our questions. We just have one quick question. So how does the Merck-Daiichi data in CDH6 change your appetite to go after FR alpha in ovarian cancer? Thanks.
Paul Moore: Yes. No, we saw that data and it looks very encouraging for a TOPO1i-based payload, that data and for ovarian cancer, we have looked at the expression profile of that target, and we feel both the folate receptor alpha and the NAPi2b expression in ovarian cancer and other cancers is supportive of also pursuing those antibody based drug conjugates. So we think that it doesn’t deflect from our motivation and excitement about those targets. We think that the profile is supported, especially when you compare it to the profile of [indiscernible]
Operator: Okay. [Operator Instructions] Our next question comes from Stephen from Stifel.
Stephen Willey: Yes. Good afternoon. Thanks for taking the questions. Maybe two quick ones. So, on the updated frontline data, zani chemo tislelizumab that was presented at ESMO, can you say if PD-L1 status was centrally determined? And I guess, do you know if BeiGene has made any attempt to go back and see if any of those sub 5% PD-L1 scores actually fell below that 1% threshold? And then I guess also pertaining to that data update, it looks like there were a bunch of patients who upon central HER2 reading were scored negative. And just wondering if there’s kind of any explanation for the disconnect there. I think there’s actually maybe five or six patients that ended up being determined negative when assessed centrally.
Ken Galbraith: Thanks for the question. For that study by BeiGene, inclusion was based on local testing confirmed centrally later. Again, small data sets, so it’s too hard to carve the numbers. I think the most important thing for us in our Phase 2 that we did in the doublet, which was centrally confirmed, so it’s a little bit different. But between both of those studies collectively, we still feel very confident that zani plus chemo is going to provide a very consistent, durable, and quick response, regardless of PD-L1 status. That’s what our data shows us right now. We can certainly see how PD-1 inhibitor on top of zani plus chemo for certain patients may provide an additional benefit to justify the immune related adverse events that come along with using a PD-1 inhibitor.
I think we’ll have to wait for the randomized Phase 3 study to understand exactly what that group is, and I think that’ll be important information for clinicians to understand the additional benefit you may see. And some of it you can see in the small Phase 2 we have, but also understand how that corresponds with the adverse event profile that goes with adding a PD-1. So we still feel very confident in the collectiveness of the Phase 2s that we’ve conducted so far that we obviously hope to confirm and need to confirm in the Phase 3 study that reads out next year and I think these little items that you talked about, I think is we’re better off waiting for the Phase 3 data to available next year to get a full understanding of that data set.
