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Wednesday, June 15, 2022 12:21:52 PM
Salveen Richter
On your pipeline outside of the infectious disease vertical, you have a personalized cancer vaccine drug with Merck, and we are going to see data in the second half. Maybe frame for us how we should be thinking about this data, because to-date, with cancer vaccines, it’s just been viewed as early proof of concept. So, is this meaningful? What are you looking for? And then what does it mean for that vertical as a whole?
Lavina Talukdar
Yes. Great question. So, you are right. We will be looking for data coming out of our Phase 2 PCV study. So, let me just explain what we are looking for in that data set. So, this is a landmark-type study that is head-to-head against KEYTRUDA as a standalone medicine for patients with adjuvant melanoma. And we are looking to show that the combination of our PCV plus KEYTRUDA shows higher percentage of people who are living recurrence-free from their adjuvant melanoma at the 12-month mark, which is why we can say that it’s – since it’s a timed endpoint, that we will have that data available in the fourth quarter of this year. And so we know that KEYTRUDA, which is already approved in that setting, shows somewhere between 60% and 70% recurrence-free survival rate at the 12-month mark. So, what we will look to do there is increase the percentage of people who are living recurrence-free at 12 mark – at the 12-month mark when they are getting PCV plus KEYTRUDA. So, it’s proof-of-concept because this will be the first instance where we can show the additive value of PCV to KEYTRUDA because it is a head-to-head study. And then once we show that data set, because we know KEYTRUDA works in many other cancers and because, by this data set, we will know if the mechanism of action is complementary, it will beg the question, where else can this mechanism of action, that’s synergistic between PCV as well as KEYTRUDA, work. And as I just mentioned, KEYTRUDA works in many other cancers, so it has the potential of really unlocking PCV working in other cancers. But first, let’s see what the data shows. I won’t get ahead of our skis here.
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