Stephen Hoge : Great questions all. So, I’ll take the first part of that. So first of all, metastatic. So we have not formally decided or announced that we’re going into a metastatic indication. We do have data from our Phase I study, our initial Phase 1 study in metastatic patients, including non-small-cell lung cancer, but we have not yet made a determination that we’re going into the metastatic indication. And I think behind your question is a view that I would agree with, which is to the extent that INT is going to provide a really substantial benefit, we think it is probably in earlier lines of therapy. So not just adjuvant, but perhaps even Stage I disease or a Stage II disease, depending on the indication, because the safety and tolerability profile is we think incredibly favorable, and the benefits we’re seeing are pretty remarkable from an immune perspective.
That said, there is still a really high unmet need in the metastatic space, and even immunotherapies like the PD-1s, like KEYTRUDA, provide a substantial benefit there. And so at the right time, we may well choose to study the metastatic indication, but as I said or metastatic indications and settings, but as I said, we have not yet formally decided to do that today, and we are really focused on adjuvant and earlier and monotherapy principally. On the manufacturing process and enrollment, we have substantially scaled up our ability to enroll patients in those Phase 3 studies. I can assure you that with our partner, Merck, we wouldn’t have opened a second Phase 3 study and be talking about the third if we didn’t have confidence in our ability to rapidly meet the demand for the substantial demand from those clinical research sites for INT manufacturing.
We haven’t specifically put out numbers, but suffice it to say, we are rapidly enrolling in those studies, and we would expect to make substantial progress this year and even perhaps getting close to completing enrollment in at least one of those studies if it continues trajectory. So we’re excited about the progress we’ve made in scaling up the manufacturing for clinical supply. We’re excited about the progress we’re making right now in enrolling patients and the demand that we’re seeing from clinical sites. And we do believe that we’ve solved a lot of the, for clinical research, for clinical development, the manufacturing requirements. The question then becomes commercial, and as we alluded to a few minutes ago, the Marlboro site would really become the purpose-built commercial site, which needs to not only be able to deliver high-quality products at high volumes, but also do it at a valuable price and cost point and all of that work is ongoing.
We’ve made great progress in building that site. Our goal is to establish that site for at least clinical supply this year, but we haven’t provided further guidance on when we will have that fully operational for potential commercial use. And ultimately, it depends upon discussions with regulators as well.
Lavina Talukdar: Kevin, we’ll take our last question.
Operator: Okay. Our last question comes from Evan Wang with Guggenheim Securities. Your line is open.
Evan Wang: Great. Thanks guys. Two from me. First, on RSV, I know there are some additional studies to expand the initial population. Can you comment on when we may see data from the Phase 3 and 50-plus in the higher-risk younger adults, and when you could potentially supplement the filing if everything’s positive? And then, I know you commented on Australia. So just, as you were thinking about or as you’ve talked about Australia as a proxy for COVID sales in 2023. Now can you comment on how interpretable Australia would be? Will it be through your RSV launch, and as we look for trends in COVID vaccination rates? Thanks.
Stephen Hoge : Great. I’ll quickly take the first part of that and then hand it over to Stéphane for the second. So the additional data on 50-plus, we have obviously immune bridging data and co-administration data. We’ll be sharing that at the appropriate time with public health officials and others. It could be as soon as the ACIP. It just depends on when the data comes in, as well as the 18-plus high-risk populations. In your question about getting those in the label, it’s important to note that public health officials can recommend use even beyond the label and may choose to do that, but our responsibility would be to get it in the label, and we will need to complete the initial BLA before then we could submit the SBLA to get that data in the label. And so obviously it would follow shortly after our hopefully successful PDUFA outcome in May.
Stéphane Bancel : Thanks, Stephan. And on Australia, so a few things. First, I mean, our team has delivered a strong performance on COVID in Australia. We’ve been helping the government since the beginning of the pandemic. As you recall, we have announced a long-term 10-year partnership with the Australian government, and we are currently building a plant in Melbourne that is advancing quite successfully, and we are in active discussions with regulators around Australia for RSV approval. The point I will make is that Australia, as you know is a quite different market commercially to the U.S. It’s really mostly driven by the government, so I will compare Australia more to a European market than to the U.S. market. I don’t think we can draw any positive or negative correlation in terms of what happened in Australia, COVID or RSV, to what will happen in the U.S. in the fall ‘24, winter ‘25.
Stéphane Bancel: Thank you so much for the questions today. Thank you for taking the time to be with us. We look forward to talking and seeing many of you in the coming days and weeks. I hope that you will have on March 27, Annual Vaccine Day in your calendar. We’ll start the presentation at 9 a.m. Eastern Time. So have a great day and thank you for joining.
Operator: Ladies and gentlemen, this does conclude today’s presentation. You may now disconnect and have a wonderful day.
