PJ Haley: Yes. Thanks for the question. With regards to the subcu formulation, I think if there’s more options for physicians and ultimately their patients, that’s a positive thing. And if there’s more convenience for the overall regimen of cabo in combination with nivolumab for first-line RCC, that’s certainly a good thing. It could provide momentum. But at the end of the day, we’ll have to wait and see how that plays out. With regards to the pembro adjuvant data, certainly impressive data in overall survival. And I think the way – I talked about this a bit before, the way we thought about it is really impressive data, great for patients. Obviously, good to see an OS benefit for them there. With regards to impact in the metastatic first-line setting, it’s – the population that’s eligible for adjuvant therapy among those nephrectomy is relatively small.
So that said, there will be some impact over time in the first-line setting, but it will take some time, we believe, to play out. Certainly, for patients who are quickly recurring, either wow on or shortly after the adjuvant treatment what we’ve heard from physicians, from KOLs is we’ll think about them in a different fashion, which could provide incremental potential or another therapeutic option. Obviously, the main other one being TKI there. But good news for patients, and I think it will take time to play out in the first line. But certainly, I think nothing but potential for cabo.
Unidentified Analyst: Got it. Thank you so much.
Susan Hubbard: Thank you, Shawn.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Asthika Goonewardene with Truist. Your line is open.
Asthika Goonewardene: Hi, guys. Thanks for taking my question and I appreciate you guys being superefficient today and being one of the quickest prepared remarks that we’ve had in a long while. I’d like to talk a little bit about CONTACT-02, please. When you look at the subsequent therapy, there was a bit of an imbalance where patients on the control arm got more chemo than patients on the cabo arm. Maybe Amy and Michael, I just wondered if you could comment on this. We already saw the current separate, but how confident do you feel that this OS benefit will still carry forward despite this imbalance? And then can I – related to that, can you maybe give us a little bit of color on when we could expect that next OS work on CONTACT-02?
Amy Peterson: Yes. So I’ll take those questions. There are a couple that are embedded in there. So first, with regard to subsequent therapy, remember what we showed at ASCO GU, we had 19% of patients getting chemotherapy in the cabo atezo arm compared to 28% getting chemotherapy in the second NHT arm. And this is important because one of the outcomes that we actually measured in terms of patient benefit was time to subsequent chemotherapy. And the time to subsequent chemotherapy was delayed with cabo atezo versus second NHT, which we actually believe to be a good thing, given especially what you heard from PJ, knowing what we know about the patients who get chemotherapy, who want chemotherapy, who are eligible to receive chemotherapy, it’s about 30% of the patient population overall.
And so delaying time to chemotherapy is not a bad thing. When we look at the OS and the confidence of OS benefit and what do we think we are going to see, I mean I can’t speculate on what we’re going to see, however, what I can say is that at the time of the analysis that we did for the interim OS analysis, we did only 49% of the target number of events. And we conducted that analysis while we were still enrolling the study. So we conducted that analysis in 507 patients of 575 that had yet to be enrolled. With that said, at this early analysis, we did see a trend that favors cabo atezo, i.e., there is no decrement to survival with a hazard ratio of 0.79 and medians of 14.6 for second NHT and 16.7 for cabo atezo, which, it is different from what we’ve seen with other studies conducted in this space that have reported their data in – contemporaneously with ours.
Now whether or not we will hit final OS is unknown. We’re looking forward to hopefully seeing that data in 2024. What I’ll say is that we did achieve the primary endpoint of radiographic progression-free survival. We believe what we demonstrated and showed at ASCO GU is clinical benefit, and it’s clinically meaningful. It was statistically significant in the ITT population, it was significant across subgroups of patients, it was consistent no matter how we sliced or diced the analysis in the ITT population or whether or not we apply PCWG working group three criteria to the analysis. And so we believe that regardless of what the final OS shows, there’s reasons to support this novel TKI IO combination for an approval in all patients who met the eligibility criteria for CONTACT-02.
So that’s patients with visceral disease, extrapelvic adenopathy, and we believe the risk-benefit profile is sufficient enough and the totality of the risk-benefit profile is sufficient enough to have a conversation with the regulators and look to see whether or not we can actually proceed with an approval. It’s important to know that our job is to bring options to patients. We focus on getting the drugs approved, the physicians focus on treating the patients with the right therapy that is approved. And I sort of mentioned that in my earlier comments, when you look at the different patient populations that exist even in studies conducted in the same space. The combination of cabo atezo is a novel potential treatment option that meet – for all those patients that met the criteria for CONTACT-02.
