And in this case, we really do see that as influenza A related for our first-generation product. But we will obviously be updating influenza B strain for other subsequent generation of products. And it’s important to note that that’s really important as you get into pediatric populations where influenza B is a burden of disease, particularly in the young. Now, on the question of PCV, we are pretty encouraged by the adjuvant melanoma data. We do have some early metastatic data, as you will note from our prior Phase 1 studies. And in the Phase 2, there was some stage 4 disease as well in that study. We did not conduct it only in first-line metastatic, and so we are actually looking forward to understanding the performance of a competitive product in that space because it may actually identify an opportunity for us to move into earlier stages of treatment.
Now, for now, our approach has been to focus on places where checkpoint, including KEYTRUDA, our standard of care and have demonstrated a really strong signal, which is why you see us expanding from adjuvant melanoma into adjuvant non-small cell, and ultimately, will go first into other adjuvant indications where we really think there is the most immediate biologic benefit or biologic rationale for potential benefit that we will be looking to demonstrate. But obviously, as others start to move into the space, if they show benefits in other lines of therapy, we will absolutely want to proceed very quickly in those directions as well. So, we are looking forward to those results, and we will obviously launching them as everyone else will.
Operator: Thank you. Next question comes from Tyler Van Buren with Cowen. Your line is open.
Tyler Van Buren: Hey guys. Good morning. Thanks very much for taking the question. For RSV, a few years from now, do you expect it to be a 2-player, 3-player or perhaps a 4-player market when including J&J? And how do you believe that the tolerability profile compared to others based on the full data presented this morning?
Stephen Hoge: Sure. I can maybe €“ I will take the first portion of that question. At this point, there are obviously three companies that have wrote out their Phase 3 pivotal efficacy studies and are proceeding right now to filing. I think €“ I don’t have a specific view on J&J, maybe Arpa can offer perspectives on that, but it is an adenovector virus program, and otherwise still unclear about their regulatory path forward. Now on the question of reactogenicity and tolerability profile, as we presented today or as our collaborator presented today at RSVVW, we do see, we think a favorable tolerability profile. Grade 3 adverse reactions, whether local or systemic, were all below 2% for any of the individual symptoms. And actually compared relatively favorably with a placebo in that arm, often maybe 1.5x as frequent as what we are seeing in placebo, which we think is a compelling overall reactogenicity profile.
We then think the other parts of the benefit of the product are obviously efficacy. We are incredibly pleased. If you look at the most common definition of cases, or RSV, lower respiratory tract disease involving two symptoms, which has been relatively consistent across the different products. We have seen high efficacy 83%, which I really think is among the best. And as we presented today, that efficacy actually holds up beautifully as you look at older populations, those over the age of 70, as well as those with higher comorbidities. Those would drive the majority of the expense associated with caring for patients, older adults with respiratory disease from RSV. So, overall, it’s very difficult, obviously, to do cross-trial comparisons. And ultimately, it will fall for public health officials to make those decisions, but we are really encouraged by both the efficacy and tolerability profile of 1345, and look forward to filing and ultimately to the commercialization of that product.
