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, there's a lot of focus on ziftomenib and the upcoming data. Could you maybe begin by providing a brief review of the efficacy and safety
data from ziftomenib's KOMET-001 trial that have already been presented?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: You've guided that topline results from the expansion cohorts in the trial will be disclosed during the third quarter this year, with a more fulsome
presentation in ASH 2022. Investors are debating how much data you actually have in-house today. I think you've disclosed in the past that you
get real-time updates from the trial. But some clues -- it's unclear how much of the data that's going to be disclosed in Q3 you are actually crunching
through right now. Could you provide investors with some sense of what you've seen and what remains to be seen?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Can you give us some sense of what will be included in the topline data disclosure during Q3? For example, how many patients, which genotypes,
what duration of follow-up?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: In terms of the topline data, [what] patients will be included in that analysis? Is there a minimum duration of follow-up that's necessary or minimum
duration that patients were on drug to be included in the analysis? And I think in the past, you've suggested that you've had patients who had
experienced other menin inhibitors that are likely to be in the analysis. Are we remembering that correctly?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: In the topline release, do you anticipate breaking down the response rates by genetic subtypes? Do you think that's even important, given the
relatively small number of patients? And just overall, would you anticipate a similar rate of response for NPM1 and KMT2A patients?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: You mentioned duration response is likely to come at ASH instead of in the topline release. Are there other elements of the data that we should
expect at ASH, other updates that will help fill out the profile of the drug?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: And differentiation syndrome, how good are the centers currently managing DS? Did the changes -- you alluded to this. But maybe to go into a
bit more detail, did the changes that you implement in the protocol really reduce the risk of Grade 5 DS?
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JUNE 02, 2022 / 7:30PM, KURA.OQ - Kura Oncology Inc at Cowen Oncology Innovation Summit: Insights for
ASCO & EHA (Virtual)
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: In light of the severity of relapsed/refractory AML itself, what rate of Grade 5 DS do you think is acceptable, and what rate of all grade DS would be
acceptable?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: In terms of the risk, are there other AEs on which Kura is focused and that you view as important in determining what dose to move forward?
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JUNE 02, 2022 / 7:30PM, KURA.OQ - Kura Oncology Inc at Cowen Oncology Innovation Summit: Insights for
ASCO & EHA (Virtual)
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: And in terms of the efficacy measures you'll be looking at, is it just CR/CRh rate or (multiple speakers) --?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: What are the likely designs for the pivotal cohorts? Do you expect to do, similar to Syndax, three cohorts across three different arms with basically
the same dosing, same design, just with different genotypes between the cohorts? Or is there some other design that's likely?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: And any sense how quickly we could see data from those pivotal cohorts?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: There is a lot of debate among investors about the competitive environment for menin inhibitors. Do you have an opinion on what efficacy or
response rate data ziftomenib must produce to be competitive? And what CR/CRh rate and durability response would give you confidence in
ziftomenib to be the best in class?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: You mentioned starting combination therapy trials maybe later this year or early next year. What is your strategy for moving ziftomenib into early
lines of development? What combination is the most interesting? Any more details on your strategy for moving forward into early lines of therapy
would be interesting.
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: That's very helpful. Maybe last question on zifto. We believe that there are at least five other menin inhibitors in development for AML. Do you
have any sense on -- about when we could see data from the other programs? Obviously, excluding Syndax who declared, but the other four, I
guess, we're all in the dark. Wondering if you have any information when we could see them.
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Maybe last couple of minutes, we can move to tipi. You've recently begun the Phase 1/2 current trial, looking at tipi and the PI3K inhibitor. What's
the rationale for combining a FTI with a PI3K inhibitor and when could we see that?
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Maybe in the last minute, any update on tipi's pivotal trial in HRAS-mutant head and neck cancer? Any visibility on when enrollment could complete?
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JUNE 02, 2022 / 7:30PM, KURA.OQ - Kura Oncology Inc at Cowen Oncology Innovation Summit: Insights for
ASCO & EHA (Virtual)
Question: Phil Nadeau - Cowen and Company, LLC - Analyst
: Perfect. With that, it looks like we are out of time. Thanks, Troy, for a very interesting discussion as always.
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