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: Anupam Rama - JPMorgan Chase & Co - Analyst
: Congrats on the data and go [Buckeyes]. So within the second-line EGFR Exon 20 data set, you guys talked about how your response rate
was lower than at the 120 mg than the 80 mg. You alluded to this being driven by some safety. Can you dig into what exactly you're seeing
in terms of the AEs impacting dose intensity.
And then a second question, just what gives you confidence in the 80 mg moving as your Phase 3 dose? And when do you think you might
have FDA sign-off to move forward with the dose?
Question: Prakhar Agrawal - Cantor Fitzgerald LP - Analyst
: I have two, so maybe first one, can you help us put into context a CNS activity of Enozertinib relative to your competitors? And secondly, if
you can just put more final details on how the overall profile of efficacy and safety you shared today compared to your competitors, especially
for the first line setting in both EGFR 20 and PACC mutations.
Question: Colleen Kusi - Baird - Analyst
: Congrats on the data presentation. So you touched on this a little bit Jacob, but just on the treatment-related AE discontinuation rates, you
said I think relative to competitors was low. But I was just curious, the discontinuation for the 80 mg dose appeared a little bit higher than
the 120 mg dose, even though we saw higher tox at the 120 mg dose.
So just any color on why you might be seeing that higher discontinuation rate?
Question: Colleen Kusi - Baird - Analyst
: Got you. That's super helpful. And then not sure how many members of the team are in Singapore for ESMO Asia this weekend, but just
curious any color from the general feedback that you're hearing from investigators on the data update.
Question: Derek Archila - Wells Fargo Securities LLC - Analyst
: So again, I wanted to get your thoughts on a potential Phase 3 design in the first-line EGFR Exon 20 patient population, particularly given
that Ami Chemo is already approved there and just how you're thinking about maybe relative to some of the other Phase 3 trials?
And then just one follow-up, since you're already evaluating Eno and combo with Ami, I guess any color on the potential treatment are you
might pursue in that trial?
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Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst
: Congrats on the data. I had two related commercial ones and then one on the data itself. In the past, you've talked about a commercial
opportunity in the US in the neighborhood of around $3 billion, $3.5 billion for [Enzo], I'm wondering if you could just walk us through a little
bit how you get to that number.
And then obviously, as you've already highlighted on the call, it is a competitive landscape, both for frontline Exon 20 and frontline PACC.
So could you just kind of discuss in a little more detail your views as to what supports success commercially in both of those settings.
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Question: Yigal Nochomovitz - Citi Infrastructure Investments LLC - Analyst
: Yes. Thanks. Yes, it was just sort of a quick one. I was just curious, in the frontline PACC patients where you have the 10% response rate in
those with the measurable CNS disease. I was just curious of those, how many also had the systemic responses.
Question: Corinne Johnson - Goldman Sachs Group Inc - Analyst
: Maybe you could talk a little bit more about your registrational trial plans. And in particular, I'm curious how you plan to further build the
case for differentiation against these CNS metastases. And how does that kind of feature as you think about patient selection and stratification
in the registrational programs?
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