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?
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?
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
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
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?
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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SEPTEMBER 14, 2024 / 5:00PM, INCY.OQ - Incyte Corp Data Highlights from ESMO 2024
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