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: Conor MacKay - BMO Capital Markets - Analyst
: Hi there. This is Conor MacKay on for Evan. Thanks for taking our question. With these really impressive data in hand, can you maybe
walk us through how you're thinking about designing a potential Phase 3 program? Understanding that you might not be able to
do a basket study in all tumor types, are there any indications that you would think about going after first?
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NOVEMBER 01, 2024 / 2:00PM, PFE.N - Pfizer Inc Spotlight on Cancer Cachexia and Ponsegromab
And then, I guess, on top of that as well, you mentioned that with ponsegromab, patients might be able to tolerate additional
treatment or sort of give physicians greater treatment flexibility, would you consider maybe evaluating overall survival in Phase 3
study as well?
Question: Edouard Mullarky - Guggenheim Securities - Analyst
: Hey, good morning. This is Edouard on for Vamil. I guess I'm still -- I guess this -- I think this will be clear up a little bit when we see
more of the trial and how the data pan out. But I guess one thing I'm trying to think of is this more going to be sort of a supportive
care therapy or do you think it would actually be really a -- kind of a therapeutic and sort of the implications on pricing there?
And then in the conservative case, it does end up being more of a supportive care therapy, can you help us think about pricing and
supportive care? Are there sort of any good analogs that we should think about in supportive care therapies and sort of what sort
of pricing point do those agents get? Thank you.
Question: Louise Chen - Cantor Fitzgerald & Co. Inc. - Analyst
: Hi, thanks for taking my question here. I was wondering if you're going to have any data or studies to show how ponsegromab can
prevent cancer deaths or help patients better tolerate their treatments. Anything objective? Thank you.
Question: Ethan Brown - JPMorgan Chase & Co. Inc. - Analyst
: Hi, this is Ethan on for Chris. Thanks for taking our question. Just in general, how heterogeneous do you view this condition? And
are you seeing similar responses across most patients or are there any notable patient profiles that could suggest a higher or lower
likelihood of responding to the drug? Thank you.
Question: Billal Jahangiri - Truist Securities, Inc. - Analyst
: Hi, good morning. This is Billal on for Kripa. Sorry if I missed this. Can you remind us what sort of impact it has on muscle given --
cachexia affect muscle significantly. Like, what's the mix of healthy weight gain between fat and lean muscle?
Question: Billal Jahangiri - Truist Securities, Inc. - Analyst
: Yeah.
Question: Trung Huynh - UBS - Analyst
: Hi, guys. Thanks for taking my question. Trung from UBS. Thanks for hosting this event. I have a couple here. Just one on the enrollment
of patients for the Phase 3 cachexia trial. So you noted that there's people across various parts of their cancer journey. There's some
patients that are at different stages. There's people who are on different treatments. Just thinking about how you're thinking about
some of these issues in getting that homogeneous patient population so you don't have any baseline population distortions there.
And then you touched on your Phase 2 in heart failure, there's certainly other diseases out there like HIV, kidney disease that are
associated with cachexia. You noted that you're looking at this. Can I clarify that GDF-15 is also the issue with cachexia in these
diseases? And is there a way the FDA could oversee a broader cachexia approval or do you have to specifically conduct these studies
in these diseases? Thank you.
Question: Dave Risinger - Leerink Partners LLC - Analyst
: Yeah, thanks very much and thanks for hosting this call. So I have a couple questions. First, with respect to GDF-15, could you just
provide more color on the mix of patients and how you're thinking about this biomarker in terms of what percentage of patients
would fall into different categories of elevation and thus what percentage of patients would benefit significantly versus modestly?
And then second, could you just speak to the administration of the drug and whether you're working on a more convenient
administration? Thank you.
Question: Dave Risinger - Leerink Partners LLC - Analyst
: Thanks so much. So can I just ask a few more then? So you're not planning on this being a biomarker selected drug in terms of patient
selection, correct? And then could you just explain what the administration of the drug is today and what could be improved?
Question: Dave Risinger - Leerink Partners LLC - Analyst
: (multiple speakers) And what's the frequency of administration? And what are you -- I'm sorry, I was just looking for a little more
color. What is the frequency of administration and when would you work on a less frequent solution for patients?
Question: Dave Risinger - Leerink Partners LLC - Analyst
: Sorry. If I could --?
Question: Xiaobin Xu - Bernstein - Analyst
: Hi, this is Xiaobin Xu from Bernstein. Thank you for your question. Could you provide more detail on why Pfizer's considerations on
the Phase 3 cachexia endpoint design and what anticipate the timeline for bettering this endpoint results. And given the importance
of the outcome data for the pricing, will there be a focus on demonstrating long term benefits beyond the weight gain such as
extended survival or improved of patient quality of life? Thank you.
Question: Steve Scala - TD Cowen - Analyst
: Thank you so much. I have two questions. First, what commercially successful cancer supportive agents should we look at as analogs
for the launch ramp and peak usage of ponsegromab?
And secondly, it looks like the product was in Phase 1 in January of 2020 and maybe well before that, so it took four and a half years
to get to this point. Why did it take so long?
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