Kura Oncology, Inc. (NASDAQ:KURA) Q3 2023 Earnings Call Transcript

And the other of course is the maintenance setting right? You want to have the most benign compound there. So that’s what we as players in the field are looking at as we look forward to the ASH presentations. And I would say we’re looking forward to sharing our early clinical data with you. It’s early, but we’re encouraged by enrollment and looking forward to sharing it in Q1.

Li Watsek: Okay. That makes sense. And then maybe just a follow-up on your own combo data in Q1. I’m just curious is there any reason to expect different responses in NPM1 versus KMT2A?

Troy Wilson: So again let’s go back to the standards of care. You would expect in general, the KMT2A patients to not respond as well. But depending on what regimen you look at what line of therapy, it’s pretty close. It’s ven/aza I believe for NPM1 is in the mid-40s. KMT2A is kind of in the low 40s. You can’t drive a truck between them. But in general the KMT2A patients probably do a little worse as you look across different regimens. I do want to be carefully again that it is though as tempting as it is, we want to just be careful, whether we’re looking at our data or at our competitors’ data you want to make sure you have enough patient experience before you try to draw any kind of conclusions on activity because you’re looking also at duration at MRD, I mean there’s a whole lot of factors here.

Our goal is to keep patients on therapy months or even years. And that’s going to be driven by safety and tolerability. It is going to be maintaining clinical activity but safety and tolerability is really going to be paramount. And it will be an interesting next two or three months here.

Li Watsek: Great. Thank you.

Troy Wilson: Sure. Thank you.

Operator: Your next question comes from Justin Zelin from BTIG. Your line is now open.

Q – Jeet Mukherjee: Yes, hi. Thanks for taking our questions. This is Jeet Mukherjee on for Justin. On the topic of the combination study with zifto, you’ve elaborated on the efficacy bar that one would want to look for. But could you just give a bit more color on the safety bar that one would be looking for at least in the context of the various cytopenias knowing that myelosuppression is very much characteristic of agents in the frontline in the relapsed refractory setting. And I have a follow-up question.

Troy Wilson: Sure, Jeet. So yeah I mean what you worry about of course, and I think you’ve correctly called it out. Cytopenias are not uncommon in the frontline setting. You do see not insignificant myelosuppression with ven/aza. So to the extent that you have an AE profile, a drug-related AE profile that runs the risk of compounding that what you run the risk of is are you going to need to dose reduce, are you going to need to discontinue, are you going to require continuous monitoring, whether it’s QT or various cytopenias. That’s what you’re looking for. The biggest risk and the thing that gets the combinations of any flavor in trouble is when the toxicity profiles are overlapping. In a Phase I study just to put it simply, you’re looking to show a combo safety profile that’s at least no worse than the standard of care, right?

It’s rare that you do better because you’re not mitigating the toxicities but you’re not looking for a lot of additive toxicity. That’s where you can create issues. So the other thing is you’re potentially looking to improve upon the backbone as you have additional experience with your agent and other agents in terms of how to combine, right can you take certain things away, can you do dose optimization, but that’s later on down the line. For these early combo studies, it’s really about what’s the safety of the backbone and then what’s the safety of your agent plus the backbone. Jeet, since you asked the question, I want to just call something out. And it’s a credit I think to our team. The way our study is designed, we begin patients on the standard of care on day one.