PJ Haley: Great. Yes. Thanks. I mean, thanks for the question, Jay. I think as Amy highlighted this is an area of certainly high on medical need for patients. So that’s really important. And we’ve heard that from KOLs all along. I think as you think about how this regimen could potentially fit in right now, obviously, the majority of patients in the 1st line metastatic castration resistant prostate setting are getting an NHT. And then beyond that, you’ve got subsequent NHT chemo. And obviously, the study addresses patients relative to a 2nd NHT. So there’s that data. But then beyond that chemo, I think it’s something that physicians and their patients, we hear consistently really want to delay in treatment. So I think a chemo list option could potentially really help that in this setting.
And then also, these are two novel mechanisms of action potentially again for the prostate cancer setting. So I think anytime there’s a lot of excitement for new MOAs in a disease setting and certainly in a setting where there’s no broadly available immunotherapy agents there certainly be a lot of excitement should this get approved for that as well so I think you would potentially see Cabo and Atezo used prior to chemo and across multiple lines of therapy depending on the patient.
Operator: Our next question comes from the line of Jing Deng from Truist.
Jing Deng: Hi, thank you for taking my question. This is Jing on line of Asthika from Truist. I have one question regarding about how do you view the impact of the recent approval of Benzo [inaudible] which is HIP two alpha inhibitor from Merck. They are trying to launch this drug in second line RCC, where we know the Cabo has a very strong presence. So yes, so I want to ask you, do you expect that this drug will be captured a significant share of the market? And how do you plan to differentiate Cabo from other drugs? Thanks.
Mike Morrissey: Okay, thanks for the question. Amy, PJ, you want to take that one? Thanks.
PJ Haley: Yes, hi, Jing. Thanks for the question. Assume you’re referring to the recently presented LITESPARK at ESMO. So obviously no approval for that data yet with the HIP inhibitor. And really, I think it’s important to realize and contextualize that that study is really in a later line setting in patients who have received IO and the TKI was head to head with [inaudible], didn’t have an OS benefit. We’ve had certainly a lot of discussions already with KOLs at ESMO and beyond about the data. And what we really see is that having likely competing in very late lines of therapy in our CC setting predominantly with tabazanib, so we don’t see any significant impact with regards to the Cabo business generally or our second line business.
Operator: Our next question comes from the line of Andy Hsieh from William Blair.
Andy Hsieh: Oh, great. Thanks for taking our questions and Amy, congratulations on your new role and look forward to working with you. So, first of all, really pleased to see the first positive IO containing regimen in prostate cancer. So, there’s a lot of moving pieces in the field. Just curious if you can give us a sense of what the FDA is looking for pertaining to OS, right? I guess if you look at the Novartis PSMA4, that allows for crossover, sounds like they want to look for something along the lines of no detriment there. Is the bar higher for CONTACT-02 just given the no crossover nature? So, that’s number one. And then kind of staying within the GU space. This morning, keynote 564, OS benefit in the adjuvant setting. I’m curious about your view on that regarding its impact to the first line of metastatic market and whether you have plans to kind of navigate through that market evolution. Thank you.
Mike Morrissey: Alright, thanks Andy. So let’s have Amy take the first part or the first question and then PJ can talk about adjuvant. Okay, Amy.
Amy Peterson: Yes, sure. So I appreciate the question and the complexity behind it. I don’t, can’t pretend to say what the agency is actually looking for. What I can say is that it’s not inconsistent with the feedback that other companies are getting. And they just want to see some more mature data. So I’ll keep you posted as that progresses. Stay tuned.
Andy Hsieh: Awesome.
PJ Haley: Yes, great. Hey, Andy. How you doing? Thanks for the question. With regards to the 564 study in the adjuvant setting, as you know that data was presented originally years ago and it’s been on the market for some time. The original OS hazard ratio while not mature was quite impressive, so to speak. So this is really no surprise. I think that these data were positive. I think it’s important to remember that this sort of high risk population as defined by the study is quite small relative to the number of patients who get nephrectomy in a given year. So we’re talking just a few thousand patients. And I think that’s already been working its way through the treatment algorithm with regards to those patients recurring in the first line setting.
So we have a pretty good feel for that. Really haven’t seen much of a significant impact to date. What we do hear is patients who potentially recur while on Pembro or relatively shortly after Pembro in the adjuvant setting. Many physicians do sort of think of them as then refractory so to speak, to checkpoint inhibition. And often then that leads them to consider a TKI monotherapy in the first line setting. And obviously with Cabo Sun 4and the totality of our data, we’re well positioned for those patients. I think overall with OS, certainly a few more positions will prescribe that. But we really don’t see much of a significant impact in the first line setting. Obviously, these things take years to develop. But we’ve kind of been in it now for a couple of years.
And it’s pretty comfortable with that analysis.
Operator: Our next question comes from the line of Yaron Werber from TD Cowen.
