We actually — Cabo-Atezo resulted in an increase in time to symptomatic skeletal events. These are attainable events for patients, so there are other outcomes that we look at. And what we also look at is the adverse event profile. And the adverse event profile that we showed with Cabo-Atezo versus second NHT. These are patients who enrolled in the study having tolerated their first NHT quite well. Median time on prior NHT was 12 months, right? So these are patients who know the toxicities of NHT and they tolerate them. And so when you juxtapose the toxicities of Cabo-Atezo against that, it looks different. I’ll grant you that. But when you look at that compared to the toxicity profile of chemotherapy, it’s very differentiated. We do not have cytopenias.
We do not have febrile neutropenia. We do not have alopecia, and we do not have peripheral neuropathy. So it’s a differentiated toxicity profile from otherwise other available therapies to this patient. And furthermore, when you look at this toxicity profile and compare it to cabo IO in other diseases where this doublet is used like kidney cancer by the same oncologists that treat prostate cancers, the toxicity profile is nearly identical. So going back to what I said at the beginning, when we talk about clinical benefit, we really need to consider a variety of parameters that we believe here we’ve met and support a robust and clinically meaningful benefit in a very unique patient population. Now I’ll go on to the zanza Arcus question, okay?
I know I went long there, but – okay. So you asked about zanza have given the data with cabo bel and not being real clear that belzutifan might be bringing in anything to the table. Let me just take a step back and remind everybody what we’re talking about with zanza is what we believe to be a best-in-class VEGFR TKI drug. It has a similar target profile to cabo, but the tolerability profile is differentiated. Monty Pal was true at R&D Day, we presented at IKCS, patients that actually responded to zanza to progress on cabo. So it’s different. We think we have an opportunity for a best-in-class. Arcus is evaluating monotherapy AB-521. We’ll see whether or not that emerges as a best-in-class agent. But there’s a reason to bring two potentially active agents together in this disease, and we’re really excited about STELLAR-009.
We are – it’s co-funded by Arcus and us, and in that study, we will test the combination in patients with RCC to figure out whether and how we might move this combination forward.
Susan Hubbard: Andy, I know you had a multi type question but we reached a long queue. So we got to need to move on to the next question. Operator?
Operator: Please standby for our next question. Our next question comes from the line of Yaron Werber with TD Cowen. Your line is open.
Joyce Zhou: Hi. This is Joyce on for Yaron. Thanks for taking our question. And thanks for all of the color on CONTACT-02. Maybe just one more on that. Could you clarify, since the study seems to have enrolled both second-line patients as well as, as you noted, about – or up to 25% of patients who had previously received docetaxel, how broad of a label you guys are aiming for here, whether it’s second line post first NHT but pre-chemo, or whether you’re also looking to get approval in post-first NHT and post-chemo. Thanks.
Amy Peterson: Thanks for the question. I’m not at liberty to really predict what might be the ultimate label, but again, I’ll go back to first principles of clinical trial design. When we design the study, we do pay special attention to the inclusion exclusion criteria. All of that is discussed with the regulators. And I would state that what we believe we have is a positive study in the ITT patient population and that this is the first positive global Phase 3 study of a TKI IO combination in metastatic castration-resistant prostate cancer patients who have progressed on at least one NHT in both pre-and post-chemo setting.
Joyce Zhou: Got it. Thank you. if I could just squeeze an follow-up. Looking at…
Amy Peterson: Joyce, I got to be honest, we have a super long list of people to get to. So we’re happy to follow-up after that call.
Joyce Zhou: No worries. Thank you.
Operator: Please standby for our next question. Our next question comes from the line of Akash Tewari with Jefferies. Your line is open.
Akash Tewari: Thanks so much. So of the kind of $950 million in R&D expenses for next year, how much is specifically zanza related? And kind of the reason I ask is if you look at cabo’s development program, you were able to share some of the development costs with Ipsen, Takeda, Bristol. And is there an opportunity to potentially do that with zanza’s development here? So how aggressively will the company be looking in terms of collaborating on zanza? And then number two, roughly how much of that spend for 2024 is zanza related? And then maybe just stepping back, for the Merck studies, which are looking at HIF-2 alpha and pembro versus TKI pembro in a first-line setting, obviously, if that hits, it would have a pretty significant impact on the market.
I’d love to get your take on whether HIF-2 alpha would be able to show a benefit on top of – HIF-2 alpha pembro would actually be able to show a benefit versus a TKI-based regimen. And to bounce off that last question, where do you see this combo of zanza and HIF2-alpha really playing a role in the market? Thank you.
