In CONTACT-02, a 100% of our patients had measurable disease versus 31% in PSMA4. Approximately a 1/4 of our patients on CONTACT received docetaxel in the metastatic setting versus zero on PSMA4. 25% of our patients in CONTACT had liver disease versus less than 5% on PSMA4. And I’m going to even pull-up some data on a meta-analysis conducted by Susanne Pallavi and in collaboration with Dr. Small who is the ASCO GU’s President that did a meta-analysis of nine randomized Phase 3 studies looking at docetaxel as the comparator arm. So, thousands of patients. And when you look at the percent of patients in those randomized Phase 3 studies on chemotherapy that actually had liver metastases, 9%. CONTACT-02 had 25% patients with liver metastases. All of these differences are due to the inclusion-exclusion criteria and situations where the treating physician and patient will look at either arm and say it is appropriate or neither is appropriate.
And this is how we design ethical clinical trials in collaboration and agreement with health authorities, steering committees, the PIs and the patients that enroll. I’ll pass it over to PJ now to address the commercial landscape.
PJ Haley: Great, thanks, Amy. First of all, we’re really excited about the data and presenting it. Metastatic castrate-resistant prostate cancer is a really large opportunity with over 75,000 patients across lines of therapy. This remains a significant unmet medical need for patients and for the physicians who treat them. The five-year overall survival rate for this population is still only 15%. So, you know, when we think about the options that exist for them, there’s obviously NHT. I would point out that approximately 50% of patients have already received NHT before they get to the first-line castrate-resistant setting. And then beyond that, really all you’ve got is radioligand therapy and chemo. Both of these therapies, obviously have limitations, whether it’s RLT with regards to logistics, issues in terms of what that means for the patient with regards to being around family, et-cetera.
And we’ve seen repeatedly in market research and in discussions with physicians that many patients and physicians want to either delay or not receive chemo. So that’s — we believe there is a significant place for this combination of cabo atezo should it be approved. Another thing I would point out here is that with only those two sort of classes of therapy available post NHT, there’s really a significant need and a great deal of excitement for new mechanisms of action in CRPC setting. And obviously this regimen has two. So a TKI as well as immunotherapy and certainly there’s a lot of potential excitement for immunotherapy in prostate cancer. So we’re excited about the opportunity. When we think about the broader treating population of community oncology, these are physicians who are very comfortable obviously with checkpoint inhibitors as well as cabozantinib across-the-board.
So we look forward to the potential in this space.
Chi Meng Fong: Great. Thank you.
Amy Peterson: You’re welcome, Chi.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Gregory Renza with RBC Capital Markets, your line is open.
Unidentified Analyst: Hi guys, it’s [Anish] on for Greg. Congrats on the progress this quarter and thanks for taking my questions. Just on the current patent litigation with MSN. I know you can’t speak to the details of the case itself, but just thinking ahead on potential outcomes in the presence for cabo’s exclusivity. Could you share how you’re framing the best-case and worst-case outcomes of the MSN2 case in relation to cabo’s exclusivity. And then just quickly on Zanza, can we expect any updates on STELLAR-002 this year? Congrats again and thanks so much.
PJ Haley: Yes, thanks for the question. I’ll take the ANDA question and then pass it over to Amy. Yes, so again, we’re not talking about specifics relative to the trial for obvious reasons and I really don’t want to speculate on potential outcome scenarios and those kinds of things. We are excited about the opportunity to move the company forward. We always do the right thing by patients and shareholders. And that will continue going forward. Amy?
Amy Peterson: Sure, thanks for the question on STELLAR-002. So that is a multi-arm study that has — it is evaluating Zanza in combination with IO, but not just monotherapy IO like a PD-1 PD-L1, but in additionally bringing other agents to the table. So for example, CTLA-4 or leg three, many of the cohorts that we’re enrolling are in earlier lines of therapy. And so it’s going to take some time for the data to mature, but we are really looking forward to sharing that as it does mature, so stay tuned for what we might be able to show in 2024.
Unidentified Analyst: Thank you.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Jay Olson with OpCo. Your line is open.
Unidentified Analyst: Hi, this is [indiscernible] on the line for Jay, thanks for taking the question and congrats on the progress. And also thanks for the color on CONTACT-02. I have two questions actually regarding to some other data presented at ASCO GU and love to hear your thoughts. So first question, I’m curious about your thinking on the potential launch of the subcu formulation of Opdivo and if that actually may create some additional momentum to the uptick of cabo nivo compared to other regimens given the pretty favorable data we saw with CheckMate and also potentially more attractive pricing with the subcu formulation of course, the easier administration. And second question, just with KEYNOTE-564 now showing OS benefit in the adjuvant setting, how would you expect the impact on the market size and potential treatment paradigm in the advent setting moving forward. Thank you so much.
Mike Morrissey: Yes, thanks for the question. I think PJ can handle those both so take it away.
