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: Christopher Raymond - Piper Sandler - Analyst
: Yeah, thank you. Thanks for this presentation. Maybe a question for Dr. DeAngelo. Dr. You've worked with Bezuclastinib and avapritinib. Maybe
just a question regarding your indolent SM patients in your practice. Knowing you have to see, I guess, the full data from SUMMIT Part 2 before
really judging, but just assuming this efficacy and safety data sort of holds up. I think I heard you say on the call regarding trial enrollment that
people are voting with their feet.
Maybe just talk about how you might decide which option Bezu or avapritinib would be best for your ISM patients once they're both sort of
commercially available. And then maybe talk about how you and your colleagues view the risk, reward trade-off here, especially on the safety side
with the choice of these drugs potentially happening as early as next year. Thanks.
Question: Christopher Raymond - Piper Sandler - Analyst
: Okay. Thank you very much.
Question: Anupam Rama - JPMorgan - Analyst
: Hey, guys, thanks so much for taking the question. Maybe a quick one for the company as well as Dr. DeAngelo. And so Andy, maybe for you, can
you talk about the enrollment curve in Summit and the factors that led to this sort of early enrollment completion? Was it more size getting online?
Was there, did you see an uptick sort of post quad AI? I think the data originally year-end and then second half and now in July.
And then for you, Dr. DeAngelo, I think one thing that the Street is debating here is really kind of the discontinuation rate that you're seeing in
non-advanced patients. I know that it's small numbers, but can you talk to that sort of benefit risk ratio following on Chris Raymond's question on
just discontinuation. And maybe talk to what portion of patients are unsatisfied with their outcomes with avapritinib at 25 mgs.
Question: Anupam Rama - JPMorgan - Analyst
: Thanks so much for taking our questions guys.
Question: Kelly Shi - Jefferies - Analyst
: Thank you for taking my questions. So in now advanced systemic mastocytosis, does the (inaudible) increase correlated with the depths of response?
And also, is it dose dependent? Or it's actually not relevant to either? Thank You.
Question: Kelly Shi - Jefferies - Analyst
: Thanks for the insight.
Question: Andrew Berens - Leerink - Analyst
: Hi, good morning and thanks for taking my questions. Congrats on the progress and the impressive efficacy. It's certainly a potent agent relative
to many of the other ones. Just wanted (inaudible) this is for the company, and then I have a question for Dr. DeAngelo. Wondering how confident
you are that you have the right dose in ISM?
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DECEMBER 09, 2024 / 1:00PM, COGT.OQ - Cogent Biosciences Inc To Host Data Release Call
I don't think we've seen lower doses in ISM. I know you had some of ASM, but correct me if I've missed it. If there aren't any lower doses, how much
efficacy do you think you would lose by going to 75 milligrams or 50 milligrams? And I know you're probably not going to specifically disclose FDA
interactions, but just wondering if you could give us an idea when Project Optimis discussions would likely have occurred.
And then for Dr. DeAngelo, Cogent has taken a different approach than blueprint. They're emphasizing efficacy versus blueprints dosing lower
and then give back (inaudible) a dose higher. Just wondering which strategy you think you would prefer an ISM. Would you prefer to start lower
and escalate as patients needed? Or do you prefer to start higher and then go lower as needed? Thanks.
Question: Sam Slutsky - LifeSci Capital - Analyst
: Hey, good morning, everyone. Thanks for taking the questions. I guess any view on what percent of avapritinib to patients are suboptimal responders
in ISM? Or I guess a different way to kind of think about it is what's the best way to think about the proportion of patients already on avapritinib
who might be able to drive additional symptom benefit from the higher dose intensity of Bezuclastinib.
Question: David Lebowitz - Citi - Analyst
: Thank you very much for taking my question. If you compare the populations of both APEX and SUMMIT in terms of what types of patients are
included with that (inaudible). How might you, I guess, put that in the context of what we saw for efficacy and potential impact on safety?
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