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: Phil Nadeau - Cowen and Company, LLC - Analyst
: Troy, some news this morning. Kura's got the abstract accepted at EHA. So maybe we'd start by laying the background and discussing what was
presented at ASH. Could you provide some highlights from ziftomenib's ASH presentation as a way of setting the table for the EHA?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: And you noted that the EHA data will be presented at a late-breaking oral presentation, I guess, in about a 1.5 weeks or for two weeks. How will
that data compare to the ASH data? What will be new or incremental, the EHA presentation, compared to what we're going to see in the abstract
this week and versus what we saw at ASH?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: I think the press release mentioned something about the abstracts being available online in advance of the meeting. What is that? Is that the actual
presentation itself or --?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: So the abstract that we get is on Thursday. Is that of an early to mid-April data cut or is that just April issue?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: That is?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Got it.
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Okay. I think the title mentioned something about mutation status of patients. Did you do your own analysis similar to the one that Syndax has
recently presented? I guess, what is the mutation status referring to?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Got it. Perfect. That makes a lot of sense. And in terms of the data released to date, including those recent abstract, how would you say that the
CR/CRh rate and duration of response in the NPM1 population compare to what you think is necessary for approval, and also compared to what
you think is necessary to become the standard of care in this population?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: And what is the importance of CR versus CRh? Is there additional benefit to a patient of having a full CR versus a CRh?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: And speaking of transplant, how should we think about the efforts, in terms of getting patients to transplant? Is transplant the treatment goal for
all patients? Does it vary based on their prior transplant status? Or clearly, it does vary based on eligibility to transplant? How do we put into
perspective the proportion of patients that go on to transplant?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: In terms of safety, the most notable adverse event, as you mentioned, is differentiation syndrome. What rate and severity of DS is acceptable do
you think, in light of the severity of the disease?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Perhaps the most common question we've been getting over the last month or six weeks on the menin class is in regards to many resistant
mutations. And the paper that I mentioned before suggests that there's about 40% of patients, get those resistant mutations.
What is cure observed in this trial? What's your perspective on these resistance mutations? Again, not to preempt anything that you can see at
EHA. But maybe in advance of that discussion, what's your most recent thinking about this subject?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: We did get one follow-up question from investors on the EHA presentation. And that's on duration of response. This investor is wondering whether
we should focus more on the duration of CR/CRh or the duration of CR/CRh and CRi? Any thoughts on that?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: In terms of the pivotal trial, what's the most recent on enrollment? I think, as of your earnings call, you suggested -- or you haven't changed the
guidance as to when enrollment would complete. You still suggested maybe mid-'24. But it sound like things were going well, and if anything, that
the enrollment might complete before it happens?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: We do want to discuss 007 and 008. But maybe before moving on to those, just one last one on pivotal trial. When could data be released? Is it
reasonable to assume six months after the completion of enrollment?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: You mentioned the KOMET-007, KOMET-008. Can you review the designs and purposes of the studies and when we might see the initial data
releases?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: And in terms of moving forward into potential registration trials in those circumstances, what do you need to see? Is it specifically safety, or is there
an efficacy hurdle that Kura has in mind that has to be surpassed?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Right. And the last couple minutes, maybe we'll turn to the FTI program. Can you give a brief overview of where to be currently stands, as well as
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Sorry, I was muted. With that, I think we're out of time. Thanks, Troy, for a very interesting discussion.
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