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: Jonathan Chang - Leerink Partners LLC - Analyst
: I'm curious to get your thoughts on the PARADIGME study results presented at ASH and how that impacts your thinking on the development
strategy for zifto?
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DECEMBER 08, 2025 / 5:30PM, KURA.OQ - Kura Oncology Inc ASH Update Call
Question: Peter Green - LifeSci Capital LLC - Analyst
: This is Peter Green on for Charles. Congrats on the data. Really great to see the thesis potentially start to play out of, honestly, frankly, really
nice safety in combination and potentially even better safety than for monotherapy, if dose. So congrats again.
Just wondering if [East data] give you any line of sight or any confidence into a potential frontline label as KOMET-017 begins to read out in
the future and whether there's any read-through from the first label in monotherapy relapsed/refractory setting, whether potentially a lot of
the language around inclusion criteria and monitoring criteria might stay through or whether if you can show an even safer profile in the
combination here, whether that's kind of grounds for negotiation for potentially even a less stringent label.
Question: Hunter Harley - Guggenheim - Analyst
: And again, congrats on the data. Again, this is Hunter Harley on for Brad. Can you know from Guggenheim. Just wanted to kind of as a
segue for this MRD conversation. And I guess, how we're kind of using this in combination. Have you reported anything on reductions for
this combination as I didn't really see that in the presentation?
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DECEMBER 08, 2025 / 5:30PM, KURA.OQ - Kura Oncology Inc ASH Update Call
And as we're kind of thinking about this with treatment long term for this combination, what are your kind of expectations for the regimen
as far as like durability, long-term usage?
And then in combination, are you planning on keeping ziftomenib on indefinitely or potentially reducing [Banesa]. And how is this kind of
combination going to look over time?
Question: Hunter Harley - Guggenheim - Analyst
: That's correct. Okay.
Question: Reni Benjamin - Citizens JMP Securities LLC - Analyst
: Congratulations on the data. There's a lot of talk looking at co-mutations like FLT3. Can you talk a little bit about the percentages of NPM1
patients that are FLT3. And can you talk about the importance of zifto being able to combine with some of these FLT3 inhibitors?
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DECEMBER 08, 2025 / 5:30PM, KURA.OQ - Kura Oncology Inc ASH Update Call
Question: Erik Lavington, Ph.D. - Mizuho Securities USA LLC - Analyst
: This is Erik on for Salim, and congrats bets on the data. So my question is on the combinations with meta inhibitor, particularly with zifto
other than ven/aza or 7 -- just wondering, assuming -- I'm assuming, and correct me if I'm wrong, that those two combinations will likely take
up the majority of usage. I'm just wondering if for these other combinations like what portion of the AML population do you think that they
would be used. And this is about like we said urea the FLT3s and all of that.
Question: Jason Zemansky - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Congrats on the progress. Maybe to connect some of the dots here regarding the KOL's previous comment, but as the menin inhibitors
advance in combination settings, what specifically do you think will be the deciding factors in terms of prescribing decisions? I mean I think
recognizing efficacy is certainly paramount.
But thus far, I think it's fair to say that each of the developers conference has been quick to highlight some distinct output and discount
some minor discount some safety issue as minor. But I guess as we're sort of seeing the preliminary evidence data come in, what stands
out to you?
Question: Philip Nadeau - Cowen and Company LLC - Analyst
: Congrats on the progress. In the discussion of the KOMET-007 data here at the meeting, one physician asked whether the addition of
ven/aza to zifto in ven-experienced patients was really adding any efficacy. The presenter of the abstract suggested maybe not -- maybe
zifto monotherapy in inexperienced patients is just as good as the triplet.
We're curious to get your thoughts on that question. Do you think the triplet is actually guiding efficacy in ven-experienced patients?
Question: David Dai - UBS AG - Analyst
: I also want to congrats -- my congratulations on the data here. So just want to follow up on the prior question around the real use of zifto
plus ven/aza relapsed refractory AML. Maybe just help us understand from a physician's point of view, what percentage of relapse refractory
NPM1 patients, do you expect to benefit from this combo use? And I'll just stop here.
Amer Zeidan - Yale Cancer Center - Chief of the Division of Hematologic Malignancies, Director of Hematology Early Therapeutics Research
I would -- this is Amer Zeidan. I think that the menin inhibitors in general, but in my opinion, ziftomenib would be widely used in this setting
because in the frontline setting, either the patient has received 7+3 and then the patient relapsed and the practical question we were having
at that time, do I give aza/ven or do I give menin an inhibitor. And now we have good data on the combination of the triplet. So that patient
would be getting all three drugs, which would be what I would recommend if I'm asked about occasion like that.
If the patient has gotten aza/ven in the front line, I think the question would be what Dr. Wang just kind of discussed is do I give him an
inhibitor by itself? Or do I give that triplet. And I think in that setting, you have to consider things like how long was the patient on venetoclax
was it -- did the patient was primary refractory or subsequently relapsed. But in my opinion, in both scenarios that I just outlined, the patient
would be getting an inhibitor likely ziftomenib.
So I think most of these patients will likely get exposed in the second line. I just want to add like kind of to the earlier question, I think what
we are trying to aim in the AML word is there really not to be in situations where you have venetoclax resistance or you have -- because
these situations are very difficult.
And even if you get responses, generally, they are not durable and patients would ultimately in most situations passed from the leukemia.
What we are trying to do is hit the leukemia very hard from the very beginning with these combinations. And we have a very nice paradigm,
outstanding paradigm in multiple myeloma where all these drugs were good in the second-line setting and third, fourth line.
And now the combinations in the frontline are just transforming the field number of patients who are achieving very deep responses, MRD
negativity and do not relapse for many years is outstanding. So I think this is where we are going to go with men inhibitors. I think they are
going to really transform the field in the frontline setting so that hopefully, we don't have to worry as much about the situations like venetoclax
failure.
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