In B7-H3, there’s prominent data that’s in small cell lung cancer, maybe in prostate. And for CDH6 itself, that ovarian data is quite interesting, and that’s raludotatug. At least for us it’s very interesting because the initial data with our partners in Daiichi Sankyo is striking to us, because in that patient population, it looked like all comers did extremely well. And that in some situations you think about a biomarker, but for the CDH6 the impact across sort of biomarker subsets was quite impressive. So I hope that gives you a general structure and we’re happy to — and thank you very much for that question.
Operator: Our next question comes from Umer Raffat with Evercore.
Umer Raffat: I’m just trying to think through your next gen HPV vaccine then. I guess how should we think about potential penetration rates with a revaccination opportunity with the new broader spectrum HPV, especially in patients who have already taken GARDASIL 9?
Dean Li: Revaccination in relationship to HPV, is that — was the questionWith the G9 plus…
Rob Davis: The new…
Dean Li: I’m struggling to answer your question, because I first got to make a G9 plus that works really, really well. And when I get that, that’ll be great because there are patient populations that I think would be extremely well served. But I would also emphasize that we’ve just talked about cancer, we’ve talked about early stage cancer. This is the time that you can really treat and potentially cure, but we’re in the business of preventing cancers as well. One of the questions that comes to us is that in certain patient populations, you want a vaccine that’s the data, for example, Scandinavia, it’s 90% reduction in cancer incidence and then the recent American Cancer Society. We are wondering whether if you make a G9 plus vaccine, whether you can make the argument if we’re successful, if we’re successful with the G9 plus and what we hope to aspire for, whether you could fundamentally change how one recommends cancer screening for women in relationship to cervical cancer and also the reduction, both in men and women of many other cancers outside of cervical cancer.
Caroline Litchfield: I’ll just add that as we sit here today, we all know there are many, many people around the world that have not received a vaccine to prevent them against — to help protect them from HPV related cancers. With the possibility of improving upon G9 with a multi-valent vaccine, we’re hopeful that we can provide further protection, especially for different population groups and we will price the vaccine appropriately based on the benefit that it will provide. So we’re looking forward to continuing to see growth in GARDASIL and see how the science evolves with our clinical programs.
Operator: Our next question comes from Tim Anderson with Wolfe Research.
Tim Anderson: I have a few questions on KEYTRUDA subcu. It may not be scientifically sexy, but of course, it could be quite commercially meaningful. So we’ll see that data I believe later this year. Any risk whatsoever to that readout or can we consider it to be a slam dunk? Second question is when the subcu launches in the US, presumably next year, will uptake be fast or slow, or somewhere in between? And then eventually, how much can a subcu account for the franchise either on a volume or a patient basis?
Dean Li: So I’ll take the first part of that. I remind myself nothing is slam dunk once you place innovative drugs in patients. So I’ll answer that question. But I think you highlighted really the pembro plus hyaluronidase that we’re advancing. I would disagree a little bit. I do kind of think it’s sexy in some ways, and that D770 that we will be sharing that data by early 2025. The reason I think it’s really an important innovation is to really increase the access. You’ve seen the number of early stage cancer readouts that are coming through with pembrolizumab and KEYTRUDA and especially in the earlier stages when we talk about KEYNOTE-671, when we talk about in renal cell carcinoma where we have OS benefit, I think this is going to be really, really important for patients.
It will also be important in patients for treatment, especially in those who have monotherapy and those especially combos with oral agents, because it just makes it so much more accessible. So we think this is an important program and that it could have substantial impact on patients and their access that PD-1 where we know the foundational elements of PD-1. In terms of financial…
Rob Davis: Maybe Tim, I’ll just provide some commentary on your questions on uptake, and I’m not sure the patient population this can account for. As we think about uptake of this opportunity, I would first point out that we see really, it starts with the strength of the clinical data underlying the IO agent itself. So it’s more about the confidence they have in KEYTRUDA and then secondarily, it’s about the delivery mechanism, which is important as we think about obviously leveraging the data we have and just the breadth of what KEYTRUDA is. But I will tell you that as we think about bringing this forward when we do launch, our goal will be to price appropriately with the goal of driving quick adoption. So we do want to see adoption happen and we do think you will see it.
Obviously, if you look at then the size of the patient population where it could be, just to give you a sense, by 2028, if we look at the patients who are on monotherapy with KEYTRUDA, who are using combinations with orals and those who are moving into earlier stages of disease through some of our adjuvant and new adjuvant areas with KEYTRUDA, that represents about 50% of the patient population at that time. So that is really the addressable market for what we see the subcu offering to be. And potentially we’re not foreclosing the opportunity to also look into the metastatic setting and people being given care in institutions, as well as those moving outside of the institutions. But obviously the value to the patient is ease of use, the ability to use it outside of the hospital setting.
The time in chair is obviously less if you’re getting a subcu versus an IV. And then from a cost to the healthcare system, the ability to not have a patient sitting in the chair for as long allowing for more patients to move through, we think actually drives access and improves the providing of care as well. So we see it both beneficial from a patient perspective and from the provider perspective. And that’s why we do think you’ll see uptake of this important medicine when we bring it forward.
Operator: Our next question comes from Louise Chen with Cantor.
Louise Chen: I just wanted to ask you for ASCO on June 3rd. Are there any specific readouts, updates that you’re very excited about presenting?
Dean Li: I think there’s just going to be a stream of data. There’s going to be follow-ups and a series whether it’d be gastric, beta cellular, biliary, bladder, non-small cell lung cancer. There’ll be discussions of many of the programs that I think you’re beginning to see coming up in the clinical trial Web site in relationship to a whole series of Phase 3 related to molecules that you’re familiar with, but also molecules that are sort of earlier in our Phase 3 development ranging from bomedemstat to the KRAS program to many of the ADCs, and the updates that we’ve shown in relationship to not just the Daiichi Sankyo ADCs, but the other ADCs whether it’d be TROP-2, Claudin or [indiscernible]. So you’ll have a whole full array of discussions of those compounds, some at the ASCO but some at the ASCO investor event.
Operator: Our next question comes from Trung Huynh with UBS.
Trung Huynh: On the WINREVAIR launch, thanks for the comments today on access and coverage. On approval, you’d noted that two thirds of your PAH patients were likely Part D and third commercial. Perhaps can you expand on the free assistance program that you’re hoping to initiate? And what proportion of those Part D patients do you think could be receiving free product this year?
Rob Davis: So as you point out, we are very focused on ensuring that patients get access to the medicine. We’re very much committed to it and that’s why we do have, in addition to our normal programs we would run, we do have the access program we run. That program is actually independent of our commercial operations. We don’t really report data coming out of that, because it’s run through a separate foundation and with the goal frankly of making sure that patients get medicines there. So that is available. It can be accessed on our Web site and we’re committed to making sure patients get the medicine, but specifics on that we’re not going to go into.
Operator: Our next question comes from Carter Gould with Barclays.
Carter Gould: Maybe on your personalized cancer vaccine with Moderna as the Phase 3 sort of nears completion of enrollment, it of course begs the question around the potential to sort of file based on the existing data you have. Can you maybe just update us on your thoughts there and whether you think you still need Phase 3 data or manufacturing would preclude an early filing? Any help there would be appreciated.
Dean Li: I don’t want to speak about whether the FDA will take what action or not, but I’ll just reemphasize to everyone what is exciting about our INT program and our excitement working with Moderna. So here we’re inducing and coaxing sort of immunity and we’re mixing it with a drug that’s well known, that unleashes pre-existing immunity which is KEYTRUDA. What we have in our hands is a randomized early stage IO sensitive trial where it is very clear, very clear of the contribution of components of the INT, not in immunogenicity but in clinical benefit. So I just want to highlight that about our data as one looks at the data of others. We also have begun to show that we are moving it in Phase 3 in adjuvant melanoma and in adjuvant non-small cell lung cancer.
And our ability to move that with speed and rigor, but get patients recruited, which is going well, I think, will be very important, because you’re going to need a Phase 3 regardless of what the FDA decides on an accelerated approval or not. And so that’s what we’re focused on. We’re also focused on looking at other IO sensitive tumors, such as renal cell carcinoma. And I would just emphasize the strength of the data in relationship to durability is being answered. The ability for us to open these trials and successfully advance it is being answered. And we clearly have work to do with our colleagues who we respect deeply for what they’ve done in relationship to manufacturing any — all mRNA vaccine, I mean, they’ve really pushed the envelope here.
Our ability to do that will be important to make this an important treatment. As far as the FDA’s decision, the FDA will need to make their decision as to how they consider the opportunity.
Operator: Our next question comes from Chris Schott with JPMorgan.
Chris Schott: Just a couple of GARDASIL questions. You’re pointing to more evenly distributed China sales this year, and seems like a tougher 2Q comp. But can you just directionally talk about growth for GARDASIL more broadly for the year? I guess, the heart of it is still a healthy growth asset for you this year. And the second one on GARDASIL is, if we were to move to a single dose of GARDASIL 9, what does that mean commercially and from a sales perspective for the franchise?
Caroline Litchfield: So in terms of the phasing of GARDASIL, as you pointed out, during 2023, we saw in China an acceleration of the shipment from the second half of the year to the first half of the year specifically to the second quarter. What that’s done is it provided an actual tailwind to revenue growth in the first quarter for China but it will provide a headwind more significant in the second quarter, and that’s what we’ve called out. As we look at overall growth for GARDASIL, given where we are with the level of vaccinations across the world, given the manufacturing that we have been scaling up, we’re confident in our ability to continue to drive growth during 2024. And in 2025, we will see our manufacturing capacity unconstrained, so enabling us to further supply and support the market.
