The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: So Ian, the latest update on the Phase 1 dose escalation study at San Antonio Breast showed consistently strong efficacy data in two times the
number of patients, and a 40% clinical benefit rate. So with the expansion ongoing, what should investors expect in terms of updates from the
monotherapy studies moving forward?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Okay. And how was enrollment for the Phase 2 of VERITAC trial been going, which is evaluating the 200- and 500-milligram doses?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Do you believe that we'll see a dose response, given that we saw strong activity at such low doses? Or what are your latest thoughts with respect
to that and how we will select -- or you guys will select a recommended Phase 2 dose?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Sure. Yeah, and efficacy as well.
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: And during the San Antonio Breast update, there were a couple safety events that popped up that we haven't seen before. But what is your guys'
general impression of those? Are those just Ns of 1 and not trends or -- curious to get your latest thoughts.
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Got it, okay. How active are you guys with Phase 3 planning? And does the recent EMERALD data impact your planning or your Phase 3 design?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Okay. Now with respect to the ongoing Phase 1b IBRANCE combo study, what safety signals are you paying closest attention to, and when should
we expect the interim safety update later this year?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Okay. With the (multiple speakers) with the vomiting, the fatigue, and the nausea, can you just remind us generally what grades those are and the
time course of those, how long they last?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: What about PK/PD with the IBRANCE combo? Do you expect the combination to have any impact on that or bioavailability?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Okay. And even though it's an uncontrolled study, is it possible that we get some efficacy data later this year? Or is that more likely a 2023 event?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Yeah. Can you remind us what doses you are looking at in that combination study?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Okay. So the combo study, obviously, you mentioned you will be looking at safety, PK/PD, but you will be, I guess, utilizing that information based
upon what you're seeing in the monotherapy trials, right, the VERITAC trials, in terms of efficacy to select that dose moving forward for the combo
as well.
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Got it. Do you have any initial thoughts on how long the Phase 3 trial might take? Is there an opportunity to, I guess, catch up on the oral SERDs in
development when you're looking at kind of front-line combination development?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Yeah. What are your latest thoughts on those studies, potentially looking at earlier line settings, where AIs are favored over fulvestrant? What do
you think 471 would need to show, or degraders in general, to be a preferred combination partner of CDK4/6 inhibitors?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: All right. Well, we'll look go ahead and switch to the AR degrader franchise, specifically bavdegalutamide, ARV-110.
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: I didn't practice that, so I'm pretty proud of it.
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: So for the ASCO GU presentation, you mentioned that you're looking for an efficacy signal of PSA50 response rate over 25%. You confirmed that
that's not necessarily what's required for approval; it was just a signal-finding study. But you guys did show that 46% PSA50 response rate and the
29% overall response rate in the patients that were eligible.
It's encouraging initial data and you mentioned that you plan to initiate an accelerated single-arm trial by year end. So what do you think will
ultimately need to be shown in this single-arm accelerated pivotal trial to achieve approval?
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MARCH 07, 2022 / 2:10PM, ARVN.OQ - Arvinas Inc at Cowen Health Care Conference (Virtual)
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Is there a way to potentially try and boost that 46% PSA50 response rate and get into the 50s like we saw at TRITON2? And kind of, I guess, with
the overall response rate, you said there could be additional follow-up. But I'm not sure if there is still additional dose exploration you could do, or
maybe excluding some of those co-mutation patients that don't respond quite as well.
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Got it. Okay. So there is a fair amount of debate over how large this mutant -- the 878, 875 mutant patient population is. So can you help us
understand your latest thinking in terms of the absolute number of patients in the US in the second -- the third-line or second-line [or greater]?
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MARCH 07, 2022 / 2:10PM, ARVN.OQ - Arvinas Inc at Cowen Health Care Conference (Virtual)
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Okay. Given the bavde or the 110 data that we have seen now, how does that lead you to think about your next-generation programs of 766 and
the V7 degrader? And are you guys even more focused on moving those into the clinic and accelerating those in terms of development? And how
do you kind of expect them all to coexist?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Is it possible that you just push off the pivotal trial plan a little bit and wait for 766? Or is the plan firmly to move forward with 110 and basically all
of them in parallel to some extent [or in sequence]?
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MARCH 07, 2022 / 2:10PM, ARVN.OQ - Arvinas Inc at Cowen Health Care Conference (Virtual)
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Okay. Right. I guess, beyond abiraterone, what combination partners do you think are particularly appealing for these agents?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: When should we, or could we, get the initial abi combo data? And you mentioned it's largely a safety study, but what should we expect in terms
of patient numbers?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Okay. Maybe turning to the wider PROTAC pipeline. You've previously mentioned that there might be four new INDs by the end of 2023. So what
should we expect in terms of new flow around the development stage pipeline, and what programs are you most looking forward to advancing
into the clinic?
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MARCH 07, 2022 / 2:10PM, ARVN.OQ - Arvinas Inc at Cowen Health Care Conference (Virtual)
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: In recent conversations with both management with new private companies and KOLs, a lot of them are saying that the -- a lot of these folks that
I'm referring to have been very successful in the targeted oncology space, developing kinase inhibitors. And one guy the other day said that the
kinome tree has largely been -- it's ripe; most of it's been picked. Maybe we're able to pick some things up off the ground, but there is this very
clear trend of them looking at other modalities, right, than small molecule kinase inhibitors, and degraders is clearly a big focus.
So I guess on that topic, just KRAS, again, one of these KOLs the other day said that if he were to start from the beginning in terms of developing
a G12C inhibitor, he would start with a degrader. So is KRAS -- I guess, obviously, it's of some interest to you guys, but how interesting do you guys
think it is? Is there -- any latest thoughts you could provide on your reference [point]?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Okay. What about -- what are your latest thoughts on glues? Now you are seeing a lot of different companies exploring glues. Obviously, you guys
historically have employed heterobifunctional degraders with PROTACs. Curious to hear your latest thoughts there.
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MARCH 07, 2022 / 2:10PM, ARVN.OQ - Arvinas Inc at Cowen Health Care Conference (Virtual)
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Okay, great. So I'd like to wrap up the fireside chat with a final question. So I'll ask you, what aspect of the Arvinas story do you believe is most
underappreciated by The Street or by investors?
Question: Tyler Van Buren - Cowen and Company, LLC - Analyst
: Okay, that's great. Well, Ian, thank you very much for the time. Really enjoyed the conversation.
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