Kura Oncology Inc at UBS Oncology Day (Virtual) Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: David Dai - UBS AG - Analyst : So maybe just for the audience here who are new to the Kura story, could you maybe provide a quick overview of Kura, and then we can dive into some of the latest and greatest over the next 12 months.

Question: David Dai - UBS AG - Analyst : Excellent. Thanks for that overview, Troy. So let's dive into some of the programs you mentioned, many different developments in the space right now. So focus on ziftomenib, especially in the relapsed/refractory AML. The PDUFA will be on November 30, so very soon actually. So we should be expecting potential approval. So could you help us understand some of the key engagement with the FDA so far? Have they performed any site inspections? Have you -- the label discussion, so far? What's the latest development on the FDA engagement with zifto ahead of the PDUFA date?

Question: David Dai - UBS AG - Analyst : Yeah. As you mentioned, given all the things happening at the FDA, have you had any kind of changes in terms of interaction with the FDA so far? Has that just been like things as usual, business as usual? Any updates here?

Question: David Dai - UBS AG - Analyst : Got it. Okay. That's really helpful. And then so on the label discussion so far, we saw that FDA would ask for their own or perform their own adjudication of complete response assessment for AML. So can you just help us understand what are some of the differences between your assessment versus FDA's assessment? And do you think this might lead to some differences in terms of CR/CRh rates?

Question: David Dai - UBS AG - Analyst : On that front, I'm just curious, is there any difference in terms of the CR assessment between the FDA's adjudication versus yours?

Question: David Dai - UBS AG - Analyst : Where could difference come from, though? I mean, we did see a difference between your competitor, right? Their assessment versus FDA label seems to be a little bit off. What do you think that could be?

Question: David Dai - UBS AG - Analyst : Got it. Yeah. That's helpful. And so then ahead of the PDUFA date, you mentioned that you're currently preparing the launch activities, especially getting market access, hiring commercial team. Maybe just tell a little more -- provide a little more granular detail around what things you're doing right now to make sure that it's going to be off to a good start once -- its launch will be off to a good start once it's approved in November.

Question: David Dai - UBS AG - Analyst : Yeah. I think that's sort of my next question, which is your competitor will launch their drug in the NPM1 setting a month before, right? And they've already seen some off-label use in NPM1 anecdotally. So I'm curious just in terms of your strategy to kind of gain market share, while you're a little bit later to the market, but your safety or your ability to combine with others might be able to offset that lateness to the game. So help us understand the overall commercial strategy there.

Question: David Dai - UBS AG - Analyst : Interesting. So you're saying that with combination with zifto -- or with combining 7+3 or ven/aza right now, is it possible to move into off-label use in frontline setting?

Question: David Dai - UBS AG - Analyst : Okay. One last question just on zifto in elapsed/refractory NPM1. So you just published the KOMET-001 data in Journal of Clinical Oncology last week. So then that also gives you a fast track to potentially include zifto in NPM1 in NCCN guidelines. So any thoughts around potential timeline as to when this will be included in NCCN guideline?

Question: David Dai - UBS AG - Analyst : Got it. Okay. It makes sense, Troy. So let's switch gears and talk about the frontline opportunity here, which is a big focus, right, especially focusing on the KOMET-017 trial in frontline AML. One thing we noticed a couple of days ago was that you just initiated -- or first person was dosed into this trial, I believe, or enrolled into this trial. And so the one thing we're just wondering is, Troy, can you provide some additional kind of color around like when are you going to be providing details around this trial, enrollment targets, powering assumptions, any kind of [plan interim] analysis?

Question: David Dai - UBS AG - Analyst : Got it. And what are some of the initial feedback from the physicians so far on using zifto in frontline setting? Maybe you can share some of the feedback, especially in those open sites on the enrollment for frontline.

Question: David Dai - UBS AG - Analyst : Very interesting, actually. And on the CR rate, MRD-negative CR for accelerated endpoint or accelerated approval, surrogate endpoints. I'm curious, any kind of updates on the level of CR -- MRD-negative CR will be considered meaningful for the FDA and also for the clinicians?

Question: David Dai - UBS AG - Analyst : Great. That's really helpful, Troy. So a couple of minutes left. Just wanted to focus on -- switch gears and focus on the FTI program, especially the most near-term update will be at ESMO, right, for darlifarnib. And so I'm curious, for darlifarnib, you're going to be showing some data in RCC. Maybe just help us understand some expectations heading into this data set, and what should we be looking for, for this data set here?

Question: David Dai - UBS AG - Analyst : Great. This is really, really helpful, Troy. We're at the top of the hour, and I think we'd just wrap up here. I really, really appreciate you taking the time to speak with us. And hopefully, you all have a good time here at our Virtual Oncology Day.

Question: David Dai - UBS AG - Analyst : Great. Thank you so much, Troy. Have a good one.