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: Stephen Willey - Stifel Nicolaus & Co Inc - Analyst
: Yes. Stephen Willey from Stifel. Thanks for the presentation. Quick question on retifanlimab. Why was the duration of therapy limited to 12 months
in the PODIUM trial? Do you think that you could have extracted additional clinical benefit by using longer-maintenance therapy?
And then maybe just another question for the company. How are you thinking about resourcing a retifanlimab commercial launch right now? You
obviously have a little bit of GI infrastructure via Pemazyre. I know you have one in the PODIUM-304 study. You're not there commercially in lung.
Is that something that you're aspiring to as well?
Question: Srikripa Devarakonda - Truist Securities - Analyst
: Congrats on all the details. I have a question for Dr. Kristeleit, but I wasn't -- I want to make sure she's online still.
Question: Srikripa Devarakonda - Truist Securities - Analyst
: Okay. So the retifanlimab data looks really strong. And you gave us a little bit of an idea of the market opportunity. I was just wondering. First, are
you already using the drug in recurrent SCAC?
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SEPTEMBER 14, 2024 / 5:00PM, INCY.OQ - Incyte Corp Data Highlights from ESMO 2024
And if approved, where do you expect it to be most used? You talked about 40% of advance patients. And if the drug were to be approved, what
percent of your patients would you prescribe the drug to?
Question: Srikripa Devarakonda - Truist Securities - Analyst
: I was just going to ask. I was going to ask about the strategy. So I know you haven't talked about the other indications where CDK2 might be
relevant. If you can't talk today, can you give us an idea of when you can talk about the potential broader opportunity for CDK2?
Question: Nick Lenard - JPMorgan - Analyst
: This is Nick on for Jess. I was hoping -- I know you mentioned that you don't have duration response yet in ovarian, but any -- based on the data
you have on hand, is there any color you can provide around that and what the duration of response could shake out to be as well as any insights
into PFS?
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Question: Nick Lenard - JPMorgan - Analyst
: I was hoping to ask another one, on the safety profile of CDK2. Just looking at that, I know there's discussion of it being consistent with the
CDK2-targeting agent and hitting it on target, but it looks so far -- looks good so far.
But at any of the higher doses or even at the 50 milligram BID or the 125 milligram QD, are you seeing any evidence of off-target or potentially any
Question: Brian Abrahams - RBC Capital Markets - Analyst
: Really appreciate the very detailed presentation. Just a couple for me. First, can you confirm that you haven't observed any ocular tox across the
arms? Secondly, what's the right way to think about your expression threshold and internal diagnostic? Any potential FDA back-and-forth or possible
pushback around it?
And then lastly, just curious on your dose selection plan for the registrational studies; and whether, 50 milligram BID, we should think about as the
most likely go-forward dose; or whether it might actually depend on whether you do monotherapy or combo.
Question: Gavin Clark-Gartner - Evercore ISI - Analyst
: So I have two. First, on the CDK2 in ovarian, what was the response rate at the 50 mg BID dose if you pool the expansion and escalation portions?
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Question: Gavin Clark-Gartner - Evercore ISI - Analyst
: Okay, got it. Secondly, what was the average time on drug until a lot of the responses have been seen? And what's your expectation for how much
the QD expansion arms, the response rate may improve over time?
Question: Matthew Dellatorre - Goldman Sachs - Analyst
: This is Matt on for Salveen. Congrats on the updates. Just three quick ones, if I may. I know it's still early, but do you think the 50 mg BID might be
best based on just what you know about the PK profile?
Second, will you share PFS data from the study in the near term? And then lastly, on the companion diagnostic for cyclin E, will this be something
that's straightforward to incorporate into a potential launch? Or would it be more of a lift?
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