Kura Oncology, Inc. (NASDAQ:KURA) Q4 2022 Earnings Call Transcript

Troy Wilson: Yeah. So let me parse that for you, because there’s a couple of things that are mixed in there. The value of the CR versus the CRh, is that you have full reconstitution of platelets and neutrophils. So if patients have incomplete responses, they’re at risk either have infection or bleeding. So that’s why we keep underlining. We observed a 30% CR rate, not CRh, not CRI that’s meaningful from the standpoint of putting the patients in the best possible position. And the second part of your question is MRD negativity. There’s pretty good evidence that MRD negativity is a useful surrogate in terms of thinking about survival. It’s not yet at the point, where it’s acceptable as a surrogate endpoint. But there’s definitely an effort underway, there’s even a consortium to do that.

You want to be able, if possible, to drive patients to MRD negativity, you can have MRD negativity with various, if you will, grades of complete response, you’d like to get as many patients as possible to MRD negativity. The question becomes, though, what are you using to measure it? Are you using flow? Are you using something more sensitive like PCR? And that’s where the devil is in the details. But, I think, we’ve been very impressed by the rate of MRD negativity that we’ve seen. We’ll look forward to getting that as one of the elements of the update mid-year really that’s going to serve as a comprehensive update on the entire NPM1 experience in the Phase 1 trial and MRD negativity will be part of that.

Unidentified Analyst: Great. Thanks for taking the question.

Troy Wilson: Sure.

Operator: Our next question comes from Eva Privitera with Cowen. Please proceed with your question.

Eva Privitera: Hi. Congrats on the quarter. And thanks for taking our questions. Clarification for the mid-year update for the Phase 1, do you expect to present data on patients who have gone on to transplant?

Troy Wilson: Eva, yeah, so thanks for the question. So we will provide an update of every NPM1-mutant patient in the Phase 1. So the short answer to your question is yes. For a patient who has gone on to transplant, we’ll €“ to the best of our ability to extend to data is in the database. We’ll give you an update on all of the patient’s experience that we’ve seen. We’ve been very impressed with not only the depth of response, but the durability of response and look forward to providing that update at the time.

Eva Privitera: Great. And I have a follow-up on the further work on KMT2A disease. What are the plans for pursuing additional monotherapy work? And will this happen prior to going into combos or kind of happen concurrently?

Troy Wilson: Yeah. So I’m glad you asked the question. If we were not at this point intending on pursuing monotherapy further. For the primary reason that we believe in order to maximize the benefit to patients, we need to pursue in the case of KMT2A, we need to pursue ziftomenib in combination. It will allow us to drive €“ we believe deeper and more durable responses, it’ll mitigate the DS. It’s also probably obvious to folks, it will also support a global marketing application, although it’s not off the table that you can do a single-arm study, for example, in Europe, it’s highly unusual. And so these combination studies set the table for ultimately a global development €“ global filing, both in the KMT2A and the NPM1. So we’ll get there just as quickly as we can, but all of our efforts going forward with KMT2A will be in combination.

Eva Privitera: Perfect. Thank you.

Troy Wilson: Sure.

Operator: Our next question comes from Reni Benjamin with JMP Securities. Please proceed with your question.