Q4 2022 Kura Oncology Inc Earnings Call
Greetings and welcome to the core oncology fourth quarter 2022 earnings conference call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
And even once you require operator assistance during the conference. Please press Star zero on your telephone keypad as a reminder, this conference is being recorded.
I would now like to turn the conference over to your host Mr. Pete de Spain. Thank you you may begin.
Thank you, Rob and good afternoon, and welcome to occur oncology fourth quarter and full year 2022 conference call. Joining me on the call are Dr. Troy Wilson, our President and Chief Executive Officer, and Tom Doyle, Our senior Vice President Finance and accounting Dr. Steven <unk>, Our Chief Medical Officer is also with us and available to answer your question.
Yes.
Before I turn the call over to Dr. Wilson I would like to remind you that today's call will include forward looking statements based on current expectations such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from expected results. Please refer to <unk> filings with the SEC, which are available from the SEC.
Or on the oncology website for information concerning risk factors that could affect the company.
With that I'll now turn the call over to Troy.
Thank you Pete and thank you all for joining us let's jump right.
In December we were proud to report updated data from our phase one trial of just a minute at the American Society of Hematology annual meeting.
<unk> is our once daily oral drug candidate targeting the Menin <unk> protein protein interaction for treatment of genetically defined AML patients with high unmet need.
The data at Ash highlighted the encouraging safety profile and clinical activity as if demand had been patients with relapsed refractory AML.
Notably the data included a 30% complete response rate with full count recovery among 20 patients with NPM, one mutant AML treated at the 600 milligram dose to our knowledge. This represents one of the highest response rates reported to date for targeted therapies in a relapsed refractory setting our media.
Duration of response had not been reached as of the Ash data cutoff on October 24th.
In addition to the strong observed clinical activity <unk> demonstrated a favorable safety profile and encouraging tolerability, which resulted in designation of 600 milligrams once daily dosing as the recommended phase II dosing schedule. Following a positive type C meeting with FDA Bill.
Building on the momentum of our phase one data and FDA interactions, we recently announced the first patient dose in our phase III registration directed trial of <unk> in <unk> mutant relapsed or refractory AML, we expect to enroll a total of 85 patients in the United States and Europe . The primary endpoint is CR.
Or CRH and key secondary endpoints include duration of response transfusion independence safety and Tolerability.
Dosing the first patient in our registration directed trial of <unk> marks a significant milestone for our Menin program and is a testament to the hard work and dedication of our team the speed with which we have begun enrolling patients in the trial also speaks to the significant interest in <unk> among investigators.
NPM, one mutant AML accounts for approximately 30% of new AML cases annually and represents a disease of significant unmet need for which no approved targeted therapy yet exist.
Although untreated NPM, one mutant AML may pretend to more favorable prognosis. Upon initial diagnosis the risk of relapse remains high and survival outcomes are poor after initial chemotherapy, particularly when other poor risk mutations such as <unk>, one or two or flit three are also present.
Notably in our phase one trial for <unk>, two thirds of NPM, one mutant AML patients who achieved a CR at 600 milligrams had either IV H <unk> III co mutations all of whom had failed prior treatment with IV <unk> three inhibitors and additional NPM one mutant patient.
Who entered the trial with multiple co mutations, including <unk>. Following two prior stem cell transplants also achieved CR with no evidence of minimal residual disease and remains unzipped amended for more than 31 cycles as of the October 24th data cutoff.
In addition to impressive activity as a monotherapy in patients with <unk> mutations, we believe that <unk> is well positioned for future combination strategies. Our conviction is supported by several key competitive advantages, including no evidence of drug induced acute Tc prolongation no predicted adverse drug drug.
Our actions and oral daily dosing that should enable convenient administration with standards of care.
Our team is working diligently to initiate the comment Oh, seven and comment Oh eight trials to evaluate <unk> in combination with current standards of care in earlier lines and across multiple patient populations, including NPM, one mutant and Kmt <unk> rearranged AML.
We've designed these phase one studies to assess the safety tolerability and therapeutic activity of <unk> in combination with key regimens such as venetic lacks in Asia Cytidine Gil to written and seven plus III. Our approach is to establish a foundation, where <unk> can be combined safely with various commonly used regiment and the.
Prioritize those combinations that represent the largest populations and greatest potential commercial value, primarily vanadic lax and flip <unk> containing regimens in.
In particular, we believe <unk> has potential to combine more safely and effectively with split three inhibitors relative to other met inhibitors in development, notably up to half of NPM. One mutant AML patients also exhibit co mutations in the <unk> <unk> we.
We also believe that rational combination approaches will help to mitigate differentiation syndrome in the Kmt <unk> rearranged population as has previously been demonstrated in the development of <unk> inhibitors in combination with decitabine.
We're very excited about the potential for our combination studies to further unlock the value of <unk> for patients with acute leukemias, we anticipate initiating the first of these studies comment zero-zero seven in the first half of 2023.
We continue to have strong conviction in <unk> and its potential to be the best in class <unk> inhibitor, and we continue to prioritize investment in the program, including significant investments in NDA preparedness as well as combination studies, we look forward to sharing further updates on the program as our as the year progresses, including.
Presentation of a more mature dataset from our phase one trial as if <unk> had been NPM, one mutant AML at a medical meeting in mid 2023.
Now, let's turn our attention to our Farnesol transfer Ace inhibitor programs.
Over the past several years, we've pioneered the development of Ftes as combination agents to delay or prevent emergence of resistance to certain classes of targeted therapies in large solid tumor indications our preclinical data as supportive of <unk> in combination with a growing number of targeted therapies, including <unk>.
<unk> inhibitors, <unk> inhibitors, as well as tyrosine kinase inhibitors in renal cell carcinoma, and <unk> inhibitors in lung cancer or.
Our next generation parcel transfer Ace inhibitor <unk> hundred 28, 6% was developed with these applications in mind Kao $28. Six was designed to improve upon potency pharmacokinetic and physical chemical properties of earlier FTA drug candidates.
Last month, we were pleased to announce FDA clearance of the investigational new drug application for <unk> for treatment of advanced solid tumors, we intend to evaluate safety tolerability and preliminary antitumor activity of <unk> hundred $28, six and a phase one dose escalation trial, which we're calling fit zero zero.
One as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors.
Clearance of the IND for <unk> 28, a six market an important next step for this program and we look forward to starting fit zero-zero, one in the third quarter.
Meanwhile, we continue to evaluate <unk> in combination with the <unk> kinase Alpha inhibitor <unk> to address larger genetic subsets of <unk> FCC patients.
In October we reported the first demonstration that the combination of <unk> can induce a durable clinical response in a pick three CA dependent <unk> FCC.
Patient at the <unk>, NCI, ACR molecular targets and cancer Therapeutics symposium, notably a patient with stage III squamous cell carcinoma of the tonsil with a <unk> mutation.
Has achieved a durable partial response in our current HN trial and has continued on study for more than 27 weeks as of the September 14th data cutoff.
Treatment related adverse events in current HN are consistent with the known safety profiles of each drug and are manageable with no dose limiting toxicities reported to date.
And our team is now focusing its efforts on identifying a recommended phase II dose and schedule for the combination with the goal of determining the optimal biologically active dose in mid 2023.
In an ongoing effort to prioritize those programs with highest potential to create value for patients healthcare providers and shareholders. We have decided to close our current lung trial and discontinue further development of <unk> in combination with <unk>.
We believe taking this disciplined approach enables us to enhance our focus on those development programs with the highest potential value, namely <unk> and <unk> 28, a six while maintaining a strong cash position.
Finally in support of our ongoing corporate development strategy, we were pleased to announce a $25 million equity investment from Bristol Myers Squibb in the fourth quarter the equity.
Investment from BMS strengthens the relationship between our organizations and provides us with key insights and expertise. We're pleased to have the confidence of the BMS team and excited to work with them to deliver innovative science with the potential to benefit patients with that I'll now turn the call over to Tom for a discussion of our financial results.
<unk>.
Thank you Troy and good afternoon, everyone I'm happy to provide a brief overview of our financial results for the fourth quarter and full year 2022.
I invite you to review our 10-K filed today for a more detailed discussion.
Research and development expenses for the fourth quarter of 2022, or $22 7 million compared to $21 million for the fourth quarter for the fourth quarter of 2021.
R&D expenses for the full year of 2022, or $92 8 million compared to $84 7 million for the prior year.
The increase in R&D expenses was primarily due to increases in clinical trial costs related to our <unk> program offset by decreases in clinical trial costs related to our to be foreign it program.
General and administrative expenses for the fourth quarter of 2022 were $12 5 million compared to $12 1 million for the fourth quarter of 2021.
G&A expenses for the full year of 2022 were $47 1 million compared to $46 5 million for the prior year.
Net loss for the fourth quarter of 2021 was $33 1 million compared to a net loss of $32 7 million for the fourth quarter of 2021.
Net loss for the full year of 2022 was $135 8 million compared to a net loss of $135 million.
For the prior year.
Net loss for the fourth quarter and full year of 2022 included noncash share based compensation expense of $6 8 million and $26 3 million respectively.
This compares to $6 4 million to $23 $6 million for the same periods in 2021.
Our cash cash equivalents and short term investments were $438 million as of December 31, 2022.
Including the $25 million equity investment from Bristol Myers, Squibb, and a one time $10 million draw from the Hercules loan facility.
This compares to $518 million as of December 31, 2021.
We believe that our cash cash equivalents and short term investments will be sufficient to fund our current operating plan into the fourth quarter of 2025, assuming no further draws upon the debt facility.
With that I'll now turn the call back over to Troy.
Thank you Tom.
Before we jump into the question and answer session. Let me lay out our anticipated milestones for this year.
<unk> dose the first patients in the comment 007 combination trial in the first half of 2023 present updated data.
From the phase one trial in <unk> mutant AML at a medical meeting in mid 2023 and dose the first patients in the comment 008 combination trial in the second half of 2023.
Particularly farnham determine the optimal biologically active dose in the current HN trial in combination with <unk> in mid 2023 and.
<unk> hundred 28 O six dose the first patients in the fit 001 dose escalation trial in the third quarter of 2023.
With that Rob we're now ready for questions.
Thank you at this time, we will be conducting a question and answer session.
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One moment, please while we poll for questions.
Our first question comes from Jonathan Chang with SBB Securities. Please proceed with your question.
Hi, guys. Thanks for taking my questions.
First question on the mid 'twenty three phase one comment 001 update can you help set expectations around what information do you plan to share and clarify whether this updates for NPM one needle patients only and then the second question on the phase II portion of the comments there is there a one study and NPL.
One patient.
Has the early experience shaped your thinking around timelines for this study. Thank you.
Thanks, Jonathan for the questions.
So starting with the update that we anticipated in mid 2023.
We do intend to focus that update on the patients with NPM, one mutant AML, who were enrolled in the phase one study.
And the intent there is to provide an update on all the patients in the study obviously one of the key questions at Ash was the durability of response and it will be in a position to provide.
Significantly more mature dataset, but.
As is customary we will give a full clinical update on all of the NPM one mutant patients on the study and recall there were 20 patients 20, NPM one mutant patients dosed at the 600 milligram dose.
In terms of.
The the experience in the phase <unk> phase <unk> and the timing for the phase two I think Thats your second question.
It's still early I mean, we.
<unk> been very encouraged we were deliberate to say that we had dosed multiple patients.
When we first put the press release out.
<unk> the initiation of the study.
And interest among and enthusiasm among the investigators has been robust.
Still in study startup that'll take really the.
First the first fully through the first quarter.
Here in the U S.
But every week that goes by we have additional sites coming online.
As you recall when when all of the sites were up and running in the phase <unk> B.
We dosed 14 patients in three <unk> <unk> thousand 14, NPM, one mutant patients in three months.
Here, we've got to get to steady state in the phase III, but we will have more sites.
From which to draw and we expect to see robust enrollment.
Okay.
Got it thanks for taking my questions.
Thank you.
Our next question is from Roger song with Jefferies. Please proceed with your question.
Great. Thank you for taking the question maybe.
Maybe just a quick two questions for Dave to Manhattan.
It is.
Given the very strong data from the phase <unk>.
Have you started the conversation with the FDA regarding the PPD potential.
And the second question is around the phase <unk> that you could call assumption given your growing 85 patients what is that now hypothesis you try to clear.
For.
In road.
85 patient thank you Troy.
Yeah. Thanks, Roger for both of those questions. So on the question of BTB, maybe stepping back for a second we intend to take advantage of every development in regulatory strategy, we can to accelerate.
The development to accelerate time to market and overtake our competition.
And I don't want to be specific on our interactions with the agency as everyone recalls we were very measured in giving guidance around our FDA interactions around the type C meeting.
I'll just tell you that again I'll reiterate anything that we can do to accelerate the timelines we intend to do we certainly feel like we have a very strong data set with a 30%.
We are right with full count recovery and NPM one mutant.
Relapsed refractory AML is is is clearly a high unmet medical need.
In terms of the second part of your your question Roger around the Phase II design. The 85 patients is really driven by safety.
That's that's our view on what's needed to support a marketing application again in the NPM one mutant relapsed refractory population, we haven't disclosed the specifics of the statistical design, nor do we intend to but again I'll reiterate to you that we intend and we built into.
Our development strategy and our protocol every opportunity to go more quickly if the data permits so I'll just leave it at that.
I don't want to get too much more into the details, but we're quite enthusiastic at the rate of enrollment the rate of interest and very much look to continue.
The trend that was becoming clear in the phase <unk>.
Great. Thanks for the comments appreciate it sure.
Our next question is from Peter Lawson with Barclays. Please proceed with your question.
Thanks Terry.
I guess just two questions when could we see the combination data when can we see that by year end.
Just as we think about you.
Dosing strategy panning out there in <unk>.
So it should be comfortable with DFS.
Thank you.
Peter Forgive me could you repeat the second part of the question I want to make sure I understood. The first part I think was clear.
Yes, so as you think about kind of a global study in EU trials in the EU.
You got it how do you think about that.
European sites.
If I can.
Yes.
Yeah, Yeah, so, let's so let's let's take that question first.
As we alluded to in the prepared remarks.
There is there are strong precedent that.
The ability to manage differentiation syndrome in combination with standards of care and that's what we're seeing with the <unk> inhibitors and if you look at the data.
The <unk> was certainly mitigated.
In the discussions we've had with investigators there very much of the mind that that should both allow us to mitigate the dms DFS that was seen.
In the phase, one and really unlock the full therapeutic value of <unk>.
So there isn't any there isn't any real concern the European sites as you know they just take longer to get up and running.
Not unusual for the some of the European sites to take nine to 12 months. So now going to kind of the first part of your question. We expect that we will have.
We're very much working toward initiation of the <unk> seven trial.
Here in the second quarter.
And I'll, just remind everybody that.
For the in the phase one we observed responses as a monotherapy at both the 100 milligram 200 milligram doses.
The starting dose in combination is at 200 milligrams. So I think we're well within the window in terms of potential activity.
I don't want to guide Peter yet to disclosure sort of timing of disclosure of data I will say, we appreciate it's a question on People's minds.
We are confident in our ability to mitigate any DFS through combination and we'll look for an opportunity if possible to share that data later this year I just I think it's premature to be more specific on venue or timing, but it's something we definitely are.
It's one of our one of our goals.
Great. Thanks, so much.
Pleasure.
Our next question is from <unk> <unk> with Cantor Fitzgerald. Please proceed with your question.
Okay. Thanks for taking my questions.
Okay.
Question.
The combo study.
<unk> is there are there is happening.
And I guess second quarter, just wondering what are the gating steps here.
And how should we think about the enrollment.
The two cohorts.
Any chance that we can see the combo data in <unk>.
This year.
Yeah, Lisa so sort of a follow on from thank you. Thank you for the two questions.
A bit of a follow on from Peter's question.
So what we're waiting for is just is the site activation and steady startup over the last several years, it's just taken longer to get sites up and running.
Not only in oncology, but but in a number of disease areas. That's just there are overloaded.
They don't have enough staffing I mean, we all sort of know whats going on our sites are very motivated. They are very engaged we have we've had no challenges at all in getting sites interested to participate now and three potential studies, the Registrational study or one 7% and I should have.
Commented in response to Peter's question, we actually will have European sites on the <unk>. One study and they are just going to come on online a little bit later than the U S sites.
As you know.
The.
We're basically what we've tried to do with the strategy with <unk> seven and OE is to make the funnel is large as possible so that any potential patient with <unk> or NPM one.
On any regimen is eligible to come into one of those two trials. That's one of the ways, we're looking to really maximize the value of <unk>.
In AML <unk>, and that's really resonated with with investigators it's likely of course that the venetic <unk> containing regimens will probably.
Go more quickly because thats those are the largest number of patients but.
We're going to open the cohorts as quickly as we can.
With regard to your question around timing I'll, just repeat what I said Peter.
The focus is very much going to be on a mid year clinical update in the NPM. One population and then as soon as it's appropriate to provide an update on the combo in either the <unk> or the NPM, one we'll look to do that and in some form and fashion.
It can't be any more specific because again the team is just cranking on getting the trial sites opened and the first patients on the study.
Great Okay.
Sorry, I had one other one other additional point that I'm just reminded us just for everybody's benefit we can of course combined data on <unk>, regardless of the combination regimen to show the mitigation of differentiation syndrome. So it's not as though we have to wait for any one of those two.
<unk> to enroll that.
Certainly the expectation is the combination will will will mitigate.
The signs and symptoms of differentiation syndrome, and we'll look to show that it's just with us not yet having patients on study, it's a little hard to crystal ball isn't as clear as I'd like it debate.
Our next question is from Brad Canino with Stifel. Please proceed with your question.
Great. Thanks for the question Troy will really be a follow up to what you just said because I just I want to get your working thoughts on Zipcode combination data now.
Quickly you think that can be used to serve as evidence that can be mitigated and really it's a question of sample size do you think it would only take a handful of <unk> patients to show that <unk> is lower and then you can drive those patients towards the response I think the corollary. There is an efficacy how do you then think about.
Parsing the contribution of efficacy from the components with a small and in that scenario.
Yes, Brad so so two good questions there.
The on the what does it take.
It's probably a little larger than a handful.
To be colloquial maybe a couple of handfuls, but if you've got.
If youre not seeing or if you're seeing sort of mitigated DSI a grade one grade two.
We're not seeing the more severe forms of DFS, you can calculate the posterior probabilities and figure out what's needed.
The more patients you have the more confidence you have but we were seeing a 30 30 plus percent rate of DFS. So it won't it won't take it won't take too long in terms of the the contributions of efficacy.
Yes.
<unk>.
That obviously will require more patients to parse them out, but I'll just remind folks neither are seven plus III, nor venetic blacks are particularly effective at driving durable responses in these patients, particularly in the <unk> patients. So you should get a signal a signal fairly early on and.
And I'll just remind you Brad we were seeing all of many of the other correlates of disease control blast count reduction.
Symptomatic improvement and so forth. So we're pretty confident that this is going to solve the problem.
And as far as the NPM one is concerned we're in good shape. There, we don't really have to take anything beyond the traditional measures to manage the DFS and this is really just a question now about <unk>.
Alright, I appreciate that if I can sneak in one on the FTC decision to de prioritize Egfr combination how should we revert to the potential kao two six combination partners because you've previously mentioned you'd be using new targeted therapy combo partners for that drug early on.
Combat partners types, where you're trying to enhance or are and we can see that earlier or versus delaying response like an egfr combo.
Yes, Brad I appreciate it.
Yes, sorry to step on your question there I appreciate the way you asked the question because you've already with your question and anticipate that the answer.
So we are seeing pre clinically.
The potential to combine.
Ftes and most notably 28, six with a number of different targeted therapies and I listed Egfr inhibitors, Patrick kinase Alpha inhibitors, you've now heard US reference Teekay is specifically in renal cell carcinoma, and K Ras inhibitors and to your specific question one of the things that were.
We're always doing is taking in data scientific data clinical data business data.
Macro economic data, we realized that we want to get to clinical datasets that will show the ability for <unk> to realize the promise of the potential for additive or synergistic activity. We think there may be opportunities Brad to do that more quickly than was.
The case with <unk>. So it was not in any way a lack of interest or enthusiasm on our part, but really a recognition that we need we operate in a world where we have to show data as quickly as possible the amount of value that we can create per dollar and per unit time as a measurement.
Our success and we want our shareholders to understand we've got we think we've got a winner was if do we think that $28. Six is looking very strong and coming on more quickly than we expected. So I think it's appropriate, particularly in these times to look at the portfolio and say where can you create the greatest amount of value.
In the shortest amount of time in the.
U S dollars and Thats exactly what we did.
Okay. Thanks again.
Sure.
Our next question is from Thiago <unk> with credit Suisse. Please proceed with your question.
Hey, this is Jeffrey Lin on the line for Thiago. Thanks for taking our questions. So we've heard a lot of discussion about the relative value of an <unk> positive CR vs and Mardi negatives CRH in the relapsed refractory setting so.
What's your perspective on that and are there any data that really address that question and then is there any read through to durability.
Yeah. So so let me parse that for you.
Because theres a couple of things that are mixed in there.
The value of the CR vs. The CRH is that you have full reconstitution of platelets or neutrophils. So if patients have incomplete responses they are at risk either of 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 patient is in the best possible position.
Yes.
The second part of your question as MRV negativity, there's pretty good evidence that <unk> negativity as a is a useful surrogate in terms of thinking about survival. It's not it's not yet at the point, where it's acceptable surrogate endpoint, but there is definitely a an effort underway, there's even a <unk>.
Horsham to do that you want to be able to if possible to drive patients to MRV negativity you can have <unk> negativity with various if you will grades of complete response.
You'd like to get as many patients as possible to <unk> negativity the question becomes though.
What are you using to measure our using flow are you using.
Something more sensitive like PCR and Thats, where the Devil's in the details, but I think we've been very impressed by the rate of <unk> negativity that we've seen we will look forward to giving that as one of the elements of the update mid year really.
That's going to serve as a comprehensive update on the entire NPM one experience in the phase one trial in <unk> negativity will be part of that.
Great. Thanks for taking the question.
Sure.
Our next question comes from Eva private Tera with Cowen. Please proceed with your question.
Hi, congrats on the quarter, thanks for taking our question.
Clarification for that midyear update for the phase one do you expect to present data on patients.
Okay.
Yes. So thanks for the question. So we will provide an update of every NPM one mutant patient in the phase one.
So the short answer to your question is yes.
Or a patient who has gone on to transplant will to the to the best of our ability to extend the data in the database. We will give you an update on all of the patient 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.
At the time.
Great and I have a follow up on.
The further work on <unk> a disease.
What are the plans for pursuing additional mono therapy work.
Will this happen prior to going into condos or kind of happen concurrently.
Yes, so I'm glad you asked the question.
But we're 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 <unk>, we need to pursue.
<unk> in combination it will allow us to drive we believe deeper and more durable responses it'll mitigate the DFS. 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 for our global global filing.
Both in the <unk> and the NPM one so we will get there just as quickly as we can but all of our efforts thus far all of our effort going forward with <unk> will be in combination.
Perfect. Thank you.
Sure.
Our next question comes from Ren Benjamin with JMP Securities. Please proceed with your question.
Hey, Thanks for taking the questions squeezing me in.
Just.
Starting off Troy can you talk a little bit about are clinically meaningful.
Medium duration of response I think in the phase one we had seen somewhere around four to five months or so and but we're looking at different doses. We had different genetic types I guess within the end of Q1 NPM one population.
What do you feel really drives kind of.
And we will give you called out.
Go ahead.
You want.
And then also I guess that was my second question just building on Brad's kind of benchmarking of efficacy in the combination studies as you think about prioritize prioritizing these studies.
Just within the <unk> 7 million eight cohorts right.
How do you go about doing that.
The efficacy is meeting your benchmarks do you focus on frontline do you just spend everything you can on both frontline and relapsed refractory any sort of thoughts as to how you start to funnel. These studies into Registrational combination studies.
Yeah. So two good questions ran in let's take them in turn so the as far as we know and the kind of the guidance that were using four to six months.
Duration of response in the relapsed refractory population is approvable now you'd like to do obviously you want to do as good as you can you want to give these patients the longest duration possible, but the bar to approval is probably four to six months.
And you are right.
We were the data was immature, but we were getting into the right ZIP code at the at the time of the Ash presentation look forward to providing an update sort of mid year here. This year consider that the NPM. One overall survival as a median of about six months without menin inhibitors. So if youre talking about 4%.
Six months duration of response that is a good improvement that's where that number comes from.
The second piece of your question is kind of a.
Prioritization and I would say the following in your scenario, where multiple regimens look good.
I would like to say, it's umbrella of you've heard me say, let's put that in our bucket of extremely high class problems right. If we've got multiple regimens that look good.
You don't have to register all of them, we will continue to be good fiduciaries and prioritize those combinations that we believe are going to drive the greatest commercial value and you already know what they are.
It's clear venetic, <unk> containing regimen with or without <unk>, let's see how that plays out would you need the trip letter the doublet and then of course, the flip III containing regimens because at least in the relapsed population a significant number of the NPM. One mutants are also flip <unk> co.
Those are probably ran the two greatest populations, but if we've got a handful of 10 to 20 patients worth of safety and activity data to support other regimens that just helps broaden the utility broadened the knowledge base and the comfort among the.
Hematologists oncologists, who ultimately are out in the community using ziff demanded so we're going to we're going to do just enough that we give everybody comfort that zip Doe is almost.
It's an amazing drug right, it's highly mutant selective extremely efficacious and yet. It is also extremely tolerable the patient say to us. The only reason I know him on the drug as I take a pill once a day in the morning.
If we can couple that up with the commonly used regimens I, we think we're in great shape.
Terrific. Thanks for taking the questions.
Our pleasure.
Pleasure.
We have reached the end of the question and answer session I would now like to turn the call back to Dr. Troy Wilson for closing comments.
Thank you Rob and thank you all once again for joining our call today, we will be participating in both the Cowen and the Barclays Health care conferences over the next several weeks and we hope to see many of you there in the meantime, if you have additional questions. Please feel free to contact Pete Tom or me. Thank you.
You all once again and have a good evening.
This concludes today's conference you may disconnect your lines at this time and we thank you for your participation.