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: Maury Raycroft - Jefferies - Analyst
: Great. That's a great intro. And maybe starting with your lead clinical program, which is darovasertib in combination with crizotnib for metastatic
uveal melanoma, where you're starting the Phase 2/3 registrational. You recently topline data in 20 frontline patients with 45% overall response
rate and PFS of approximately seven months. And -- which looks better than standard of care. What would you highlight about the data?
Question: Maury Raycroft - Jefferies - Analyst
: Great. And what could you tell us about the background characteristics of these patients, particularly in terms of extrahepatic metastases, LDH or
HLA status.
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And for the data you showed, how does safety compare to other programs in metastatic uveal melanoma?
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JUNE 07, 2023 / 4:30PM, IDYA.OQ - IDEAYA Biosciences Inc at Jefferies Healthcare Conference
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And for the registrational study, so you're in process of launching that. Can you talk a little bit about the rollout of the study? When you
could potentially dose the first patient? And talk about the study designed to and how you came to that study.
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And for the different dose work that you're doing, is there anything specific that you're looking for on safety or efficacy? And would you
provide some sort of an update based on that?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And what's your level of confidence that you'll be able to file for accelerated approval on the Phase 2 PFS from a regulatory standpoint?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And you plan to enroll approximately 230 patients into the Phase 2 portion of the registrational study. Can you give us any color on how
quickly you could enroll, based on historical enrollment rates in the earlier Phase 2 study?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And you're allowing investigator's choice for control in your study, including checkpoint inhibitors. What do checkpoint inhibitors do in this
setting? And how do you think they could perform in terms of PFS and OS?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And we'll talk more about competition later. But just wondering if you can talk about activity, your combo is shown in hepatic-only patients
in the frontline setting. And how this could set up potential for your combo as a preferred treatment in this group of HLA-positive patients to
capture some of the Kimmtrak opportunity?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And for HLA-positive patients, you're enrolling a subset of approximately 40 to 50 patients with potential to publish or include in the NCCN
Guidelines. Maybe talk a little bit more about the strategy there? And can you clarify if these patients are going to be second line or first line?
Question: Maury Raycroft - Jefferies - Analyst
: Got it.
Question: Maury Raycroft - Jefferies - Analyst
: Got it. That's helpful. And just wondering what you learned more broadly from the Kimmtrak launch? And do you believe there could be a bolus
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And just wanted to check to if there's anything else at ASCO that you learned related to the uveal melanoma space you want to highlight?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And for neoadjuvant, can you talk a little bit more about the market opportunity there, both in terms of size? And maybe how durability
might differ with versus metastatic uveal melanoma? And are you viewing these as patients that eventually progress to metastatic uveal melanoma?
That you're getting earlier with daro treatment or how do you see that?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And what can a registrational path look like in the neoadjuvant or adjuvant settings, given your Phase 2 trial is looking in both settings? Is
the bar clear in the neoadjuvant setting, given the primary endpoint of eye preservation and decrease in radiation dose versus adjuvant, which is
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And for uveal melanoma, you're supposed to have a clinical program update second half of this year. Any more granularity on what could
be included in that update?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And we're almost out of time, but for MAT2A, you recently announced that your IND was cleared for that program in combo with Amgen's
PRMT5-MTA cooperative drug. Anything about this program you want to highlight and anything on timelines you can mention?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And for the PARG program that's wholly owned. Maybe just provide some highlights for that program and where you're at with the study.
Question: Maury Raycroft - Jefferies - Analyst
: Got it. A lot more that we could talk about in the pipeline. Maybe I'll turn it over to you to close out with key highlights that you want to mention
and then catalysts ahead that investors should be focused on.
Question: Maury Raycroft - Jefferies - Analyst
: Great. Thanks so much for joining us today.
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JUNE 07, 2023 / 4:30PM, IDYA.OQ - IDEAYA Biosciences Inc at Jefferies Healthcare Conference
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