Samit Hirawat: Thank you, Evan. I think it’s a good question, and the reason we believe that it is important for us to be able to highlight this are multifold. Let me start off by saying, remember last year at R&D Day, we had said that there are two platforms that are very critical and we believe in, and we are continuing to progress on them. ARLDD, the molecule is the first protein degrader from that platform that goes into solid tumors. And we wanted to absolutely be able to demonstrate that it is, as we anticipated, it is progressing well, showing efficacy and manageable safety profile in patients with late-line prostate cancer. As you saw from the data, the PSA-30, PSA-50 reductions, the durability of that — and those are truly correlated if you look at the data sets as well as in literature, the correlation of that impacting the overall survival.
So we are truly excited about what we’ve seen thus far. We are of course enrolling more patients. We are in the dose optimization phase. We’ve had interactions with regulatory authorities and now planning for initiating the next phase of development registration trials within the next six months to twelve months. Let me just pass it over to Adam to comment further from his perspective as well.
Adam Lenkowsky: Yeah. Thanks, Evan. Thanks for the question. So we’re excited about, as Samit said, the platform of protein degradation and as it relates to ARLDD in prostate cancer. This diversifies our IO portfolio even further to complement some of the recent deals. We had a number of KOL and community feedback coming out of the ASCO Gu presentation. And appeals have been enthusiastic about the profile, particularly around the efficacy of the asset, the durability of response. And when we asked community physicians, they were reassured around the safety profile as well, stating that it was a manageable safety profile. And they were enthusiastic about moving this into Phase 3 registrational studies, and look forward to having the opportunity to treat patients with late-line prostate cancer.
Tim Power: Let’s go to the next question please, Andrea.
Operator: The next question comes from Carter Gould of Barclays. Please go ahead.
Carter Gould: Great. Thank you. Good morning. Thanks for taking the question. For Adam, I wanted to come back to Camzyos. You sort of have shown a pretty steady kind of addition of sort of the same number of patients for each quarter. I would expect sort of now that you’ve gotten your feet underneath with the launch. That number would be increasing sort of, each quarter like we see with most launches, which I guess suggests there’s some other sort of gating factor, whether that’s logistics or whatnot. Can you maybe, elaborate on what you’re seeing and whether you disagree or agree with kind of how I frame that there? And to whatever extent you can comment on the trends going forward in ’24? Thank you.
Chris Boerner: Adam?
Adam Lenkowsky: Sure, Carter. Thanks for the question. So we are continuing to make very good progress with Camzyos. As we talked about, we’re investing further behind the brand in unbranded and branded direct-to-consumer. We do expect to see continued steady and consistent growth. As David mentioned in his opening remarks, we’re averaging around 1,000 patients on a quarterly basis. Patient and physician feedback continued to be very positive. Remember, these patients are going to be on treatment for a very long time. And taking you back to JPMorgan, if you recall, Chris showed an analog where Camzyos is tracking akin to a very strong TV launch, in this case, Entresto. So this is the way that cardiovascular launches uptake. And we are focused on continuing to drive breadth in our top COEs. We’re continuing to expand outside of our top COEs, and we’re working to increase diagnosis rates by activating patients via our new DTC advertising.
So that coupled with new launches internationally, we are confident that this is going to lead to continued and sustained growth for this important brand.
Tim Power: Let’s go to the next question please, Andrea.
Operator: The next question comes from Mohit Bansal of Wells Fargo. Please go ahead.
Unidentified Participant: Hi. This is Serena on for Mohit Bansal. Thanks for taking our question. So I wanted to ask about the Phase 2 Opdualag readout coming out early this year in first-line lung cancer. I was wondering how meaningful you think this data could be considering that the comparator arm is Opdivo Chemo versus Opdivo Yervoy being the approved regimen. Thank you.
Samit Hirawat: Thank you for the question. Obviously, we’re looking forward to seeing the data for Opdualag, a randomized Phase 2 study looking at the combination of Opdivo relatlimab plus chemotherapy comparing to Opdivo Chemo. The intent of doing this is twofold. One, we wanted to get the contribution of component question out right away so that we can show the contribution of relatlimab on top of Opdivo with chemotherapy. And number two, we also wanted to plan this study so that we can — when we do go to Phase 3, the appropriate control arm that is most widely used right now is pembro-chemo. And therefore we are set for that, dependent, of course, on the data. So later this quarter and this year, you will be able to hear about the data. And then based on the data, we will be making decisions on where to go with this drug.
Tim Power: Perfect. Thanks, Samit. Let’s go to the next question, please.
Operator: The next question comes from Robyn Karnauskas of Truist Securities. Please go ahead.
Unidentified Participant: Hey, guys. Thank you so much for taking my question. This is Kuban (ph) for Robyn. I have a follow-up question on Camzyos. Just wondering if you can talk a little bit about, how you think the recent data from a competitor might broadly impact the landscape in HCM. Obviously, the drug is not approved yet, but do you see these data improving awareness? And based on that, do you expect to see any sort of inflection points? And also can you talk a little bit more about your efforts ex-U.S.? And if we should continue to see steady growth or any sort of inflection points based on the reimbursements that you expect? Thank you.
Chris Boerner: Samit and Adam?
Samit Hirawat: Yeah. Thank you for the questions. The way we would look at it is that the competitor data actually further strengthens our confidence in Camzyos. And within the Camzyos clinical trials, we now have three Phase 2 trials that have read out with amazing transformational data. You’ve seen the data for Explorer, you’ve seen the data from Weller, and recently we had the readout of a Phase 3 trial in Japan as well, which replicates the results that we’ve already seen for the first two trials. As Adam would tell you, we’ve treated now thousands of patients and that data also continues to showcase the efficacy of the drug as well as maintains the safety of the drug. As you will see when the data are presented from the real-world setting at ACC, what the overall safety profile of the drug is.
So in general, what I would say is that Camzyos lives up to its promise of a transformational potential for the patients. And any patient who goes on that drug usually doesn’t want to come off because of the benefit that they’re achieving.
Chris Schott: Adam?
Adam Lenkowsky: Yes. Thanks for the question. So certainly when we look at the top-line data from SEQUOIA is consistent with our internal expectations, we’ll obviously need to see the data set, but ultimately we don’t see any clinically meaningful differences in the data. In fact, when we spoke to many TLs after those data were shared, they have stated that apocampton (ph) data appears similar and undifferentiated from Camzyos. They also, of course, want to see the broad data set. They also talked about the difference in PVO-2 being not a clinically meaningful endpoint. And likely any differences are due to differences in patient populations across the two studies. I can show you we will certainly be prepared for apocampton (ph) when it comes to market with our leading cardiovascular organization and we have maintained a consistent view that we will remain leaders in this space.
I’ve also said though, that important thing to keep in mind with this class is we do see that another competitor could be a net positive to help drive awareness for patients with symptomatic OHCM and increased diagnosis rates, which is also really important. Finally, as relates to expansion outside of the U.S., we’re just starting to see expansion outside of the U.S. We’ve launched in Germany, we’ll prepare to launch in Japan, in China in mid-year, and a host of other markets. So we’ll start to see those sales manifest in the back end of the year and into 2025.
