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: Peter Lawson - Barclays - Analyst
: Great. Thanks so much. Thanks for the update. I I guess first question would just be around how prior therapies affected the response rates. You
know, so patients that had Veneta flex or didn't have Veneta flex, how that kind of check out and then the follow up question, which would be
around what percentage of patients in the real world setting would you kind of put into this post transplant Manning setting? Kind of how would
you triangulate around that? Thank you.
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NOVEMBER 12, 2024 / 1:00PM, SNDX.OQ - Syndax Pharmaceuticals Inc To Discuss The Results Of The
AUGMENT-101 Trial In R/R mNPM1 AML
Question: Anupam Rama - JP Morgan - Analyst
: Hi, thanks for taking the question. This is actually Malcolm Ko on for auto. This one's for Dr Stein. When you look at the totality of the data, is it CR
or a CRh or Orr that is really going to drive your use of the product? Thank you.
Question: Anupam Rama - JP Morgan - Analyst
: Great. Thank you.
Question: Bradley Canino - Stifel - Analyst
: Good morning. Great to see the results. I want to go back to the discussion on Peter's first question because I think it's, it's noticeable that efficacy
expectations have been anchored. The mid 30% results reported from an inhibitors and NTM one phase one. But how should we think about that
when a baseline rate of thela exposure in those earlier studies was lower at 60% to 65% versus the 75% you're reporting today.
And then I know this question came up for the KMT2Ar cohort when you reported that last year. So could you bridge the safety population to the
FCC population denominator? Was that all patients just with insufficient follow up, they weren't included in the FC valuable. Thank you.
Question: Bradley Canino - Stifel - Analyst
: Thanks much.
Question: Kelly Shi - Jefferies - Analyst
: Hi, good morning. This is Clara on for Kelly. Thanks for taking our questions. So, based on the new data today, together with the KMT2 with pivotal
data, how should we think about the bar for the pivotal combo study with then as that in first line and also for the sNDA filing in first half of 2025.
Are you planning to use the data you presented today or you plan to collect data with longer follow up? Thank you.
Question: Kelly Shi - Jefferies - Analyst
: Yeah, of course. So just based on the data and the NPM1 pivotal data and KMT2Ar pivotal data, how should we think about the bar for the, the
pivotal combo study which then adds on in frontline.
Question: Michael Schmidt - Guggenheim - Analyst
: Hi, this is Paul on for Michael Congrats on the data and thanks for taking our questions. So just on the rates of CR CRh heading into the data, there
was some discussion that responses could potentially be, you know, slightly higher than what you saw in the KMT2A population.
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NOVEMBER 12, 2024 / 1:00PM, SNDX.OQ - Syndax Pharmaceuticals Inc To Discuss The Results Of The
AUGMENT-101 Trial In R/R mNPM1 AML
Due to lower rates of patients going to transplant, you just comment on how transplants ended up factoring into the response rates that you saw
and then our second question is on the grade for QTC prolongations. Could you just expand a bit on those patients who had events? Were there
any co morbidities or control medications that factored into that? Thank you.
Question: Jason Szymanski - Bank of America - Analyst
: Good morning everyone. Thank you. Congrats on the data and thanks for taking our questions. If we could return to safety. I, I know you've touched
on this, but maybe kind of positioning things this way. Obviously, there were a couple of grade four instances of QTC prolongation and Ds. But as
a whole, could you comment on maybe why these rates seem overall higher versus the KMT2A population? And fundamentally, does this change
your outlook regarding the potential of either a black box warning or REMS A at least for the NPM1 population.
Question: Justin Zelin - BTIG - Analyst
: Thanks for taking our question and congrats on the data here. Maybe a question for Dr Stein. The the transplant rate seen in this data set 17%. Do
you expect that to be consistent in, in the real world with revive or, or do you expect with more experience that we might see that translate
transplant rate get higher over time?
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NOVEMBER 12, 2024 / 1:00PM, SNDX.OQ - Syndax Pharmaceuticals Inc To Discuss The Results Of The
AUGMENT-101 Trial In R/R mNPM1 AML
Question: Justin Zelin - BTIG - Analyst
: Got it. Thank you. And, and maybe just one for anyone on the call just about the duration of response here. Do you, do you expect this to increase
with time? You know, with some of that dynamics contributing from the transplant patients?
Question: Justin Zelin - BTIG - Analyst
: Thanks for taking our questions and congrats again.
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