Karyopharm Therapeutics Inc. (NASDAQ:KPTI) Q2 2016 Results Earnings Conference Call August 4, 2016 8:30 AM ET
Justin Renz - Executive Vice President and Chief Financial Officer
Michael Kauffman - Chief Executive Officer
Sharon Shacham - President and Chief Scientific Officer
Brian Abrahams - Jefferies
Whitney Ijem - JPMorgan
Jonathan Chang - Leerink Partners
Michael King - JMP Securities
Arlinda Lee - Canaccord Genuity
Laura Chico - Raymond James
Good morning. My name is Shane and I will be your conference operator today. At this time I would like to welcome everyone to the Karyopharm Therapeutics Second Quarter 2016 Financial Results Conference Call. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the company's request.
I would now like to turn the call over to Mr. Justin Renz, Executive Vice President, Chief Financial Officer and Treasurer of Karyopharm Therapeutics.
Thank you and good morning. Welcome to our second quarter 2016 earnings call. This is Justin Renz and I'm joined today by Dr. Michael Kauffman, our Chief Executive Officer; Dr. Sharon Shacham, our Founder, President and Chief Scientific Officer; and Chris Primiano, our Senior Vice President of Corporate Development, General Counsel and Secretary.
On the call today, Michael will make some introductory comments, Sharon will provide a short update on the clinical development programs and plans and I'll provide an overview of our second quarter financial results. Michael will then provide some summary remarks and we'll open the call up to your questions for which Chris will also be available.
Earlier today, we issued a press release detailing Karyopharm's results for the second quarter 2016. This release is available on our website at karyopharm.com.
Before we begin our formal comments I will remind you that various remarks we will make today constitute forward-looking statements [indiscernible] of the safe harbor provisions under Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments and regulatory timelines, the potential success of our product candidates, financial projections and our plans and prospects. Actual results may differ materially from those indicated by these statements as a result of various important factors, including those discussed in the risk factors section of our most recent quarterly report on Form 10-Q which is on file with the SEC and any other filings we may make with the SEC including our quarterly report on Form 10-Q for the second quarter of 2016 which we expect to file later on today.
Any forward-looking statements represent our views as of today only and should not be relied upon as representing our views as of any subsequent date. We may elect to update these forward-looking statements at some point in the future. We specifically disclaim any obligation to do so even if our view should change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.
I will now turn the call over to Dr. Michael Kauffman, Chief Executive Officer of Karyopharm.
Thank you, Justin and good morning everyone. Thank you for joining us on our call today. We've had a strong first half of 2016 as we continue to drive rapid and meaningful progress across several of our development programs. Our lead product candidate, selinexor is a first in class oral Selective Inhibitor of Nuclear Export or SINE compound, which his currently in development for hematologic and solid tumor malignancies.
As you know, a key focus of the selinexor program is in multiple myeloma and we have made several significant advancements that I'd like to highlight. In June, we announced the completion of enrollment in one of our most advanced trials, the STORM Phase 2b study evaluating selinexor in combination with low-dose dexamethasone in patients with refractory multiple myeloma. The primary endpoint of the STORM study is overall response rate. We expect to report topline data from 79 patients in September 2016 at which point we plan to announce the next steps in our overall multiple myeloma development strategy.
Second, at this year's European Hematology Association Annual Meeting we presented Phase 1b data from the ongoing STORM study evaluating selinexor and low-dose dexamethasone in combination with standard-of-care agents in patients with relapsed refractory myeloma. Sharon will review the results from the STORM study in more detail in a few moments, but we will look forward to reporting additional topline data from this Phase 1b portion of STOMP in late 2016.
And third, we continue to assess the feasibility of a potential Phase 2/3 study which we referred to in the past as the SCORE study, evaluating the combination of selinexor, carfilzomib and dexamethasone in patients with refractory myeloma who are previously treated with a proteasome inhibitor and an immunomodulatory agent.
I'd now like to turn the call over to Sharon to discuss the trials and data in more detail as well as provide an overview of important presentations in publications that occurred during the quarter. Sharon?
Thank you, Michael. As Michael mentioned earlier, we have recently completed enrollment in the STORM study a Phase 2b single arm, clinical trial evaluating the activity of selinexor in combination with low-dose dexamethasone for the treatment of refractory multiple myeloma in 79 patients.
In this study, selinexor is being evaluated in heavily pretreated patients. These patients have all received bortezomib, carfilzomib, lenalidomide and pomalidomide, which we refer to as having quad-refractory in multiple myeloma. In addition, 30 out of the 78 patients in this study with measurable disease had myeloma that was also refractory to an anti-CD38 monoclonal antibody, such as daratumumab, which we refer to as having penta-refractory myeloma. We believe these patients represent the unmet medical need population.
To put this in context, we are not aware of any study that has reported response rates for agent in the penta-refractory setting. Data we have recently published on the response rates for the anti-CD38 monoclonal antibodies in the patient with quad-refractory myeloma. Daratumumab response rate in this quad-refractory population was 21% while [indiscernible] was 20%.
The completion of enrollment for STORM is an important milestone for selinexor and we look forward to reporting topline results in September 2016. These results will allow us to determine the best path forward which may include expanding the trial to include additional patients with penta-refractory myeloma.
Despite the availability of many newly approved therapeutic agents, myeloma remains a fatal disease with essentially all patients relapsing after all available treatment. We believe that a positive outcome from the STORM study could potentially serve as the basis for an accelerated approval for the treatment of patients with refractory multiple myeloma.
Next, I'd like to provide an overview of the exciting Phase 1b STOMP data that we have recently presented at EHA 2016. As a reminder, STOMP is evaluating selinexor and dexamethasone in combination with standard-of-care agents in patients with myeloma. In this study the selinexor plus dexamethasone, plus bortezomib in combinations has achieved an overall response rate of 69% and had a clinical benefit rate of 88%.
10 of these 16 evaluable patients in the selinexor- bortezomib combination arm had multiple myeloma previously refractory to proteasome inhibitors and several had high risk haplotypes including deletion of chromosome 17p. Seven of these 10 patients responded to an overall response rate of 70% including one complete response and one very good partial response and five partial responses.
The selinexor plus dexamethasone, plus pomalidomide combination arm achieved an overall response rate of 57% and a clinical benefit rate of 71%. Data from selinexor, plus dexamethasone, plus lenalidomide arm were immature and enrollment is ongoing.
Our first all arm, the most common adverse events are anorexia, nausea, fatigue and thrombocytopenia which was similar to or lower than those historically observed with selinexor or the backbone therapy separately.
In order to broaden our evaluation of selinexor in myeloma a new investigator sponsored Phase 1 clinical trial was initiated in July which will evaluate selinexor in combination with the first and only approved oral proteasome inhibitor, ixazomib and low-dose dexamethasone in patients with refractory multiple myeloma. The ixazomib regimen were present in all combinations for patients with myeloma.
So the next gynecological cancer, we have completed enrollment in the Phase 2 SINE study and we look forward to presenting near final data in an all presentation at ESMA 2016. This updated data is [indiscernible] on topline results reported at ASCO 2016 which demonstrated that selinexor induced single agent this is control [indiscernible] rates which is designed as a partial responses of stable disease of at least 12 weeks in patients with ovarian and endometrial cancer at the rate of 55% and 62% respectively.
Beyond selinexor, we also continue to advance our other pipeline candidates. Our second generation oral SINE compound KPT-8602 continues in its first-in-human study with updates anticipated later this year. In contrast to selinexor, this second generation compound has minimal blood-brain penetration and showed reduced side effects in animal models.
A key highlight from the second quarter was the advancement of KPT-9274, oral dual inhibitor of PAK4/NAMPT into clinical development for the treatment of advanced solid tumor as well as non-Hodgkin's lymphoma. To our knowledge, we are the only company with a compound in clinical development directly targets both PAK4 and NAMPT and we look forward to reporting topline data in mid-2017.
With that, I'll turn the call over to Justin to discuss our financials.
Thank you, Sharon. Since we issued a press release earlier today outlining our second quarter 2006 financial results, I'll just review the highlights and then speak to our cash balance and our financial guidance.
Karyopharm reported a net loss of $30.2 million, or $0.84 per share, for the quarter ended June 30, 2016, compared to a loss of $32.7 million, or $0.92 per share, for the quarter ended June 30, 2015. Net loss includes stock-based compensation expense of $6.4 million and $4.5 million for the quarters ended June 30, 2016 and June 30, 2015, respectively.
Research and development expense was $24.6 million for the quarter ended June 30, 2016 compared to $27 million for the quarter in 2015. The $2.4 million decrease in R&D expenses are primarily related to the completion of selinexor's clinical trial, supply, manufacturing and toxicology studies in 2015.
General and administrative expense was $6 million for the quarter ended June 30, 2016 compared to $6.2 million for the quarter ended June 30, 2015. Cash, cash equivalents and investments as of June 30, 2000 including restricted cash totaled $166.2 million compared to $187.1 million as of March 31, 2016. We expect to end 2016 with a cash balance greater than $120 million.
As Michael mentioned, based on our current operating plans we expect that this existing cash will fund our research and develop programs middle of 2018, including advance our STORM, SOPRA, SADAL and SEAL clinical studies at their next stage inflexion point.
I will now turn the call back over to Michael Kauffman for concluding remarks. Michael?
Thank you, Justin. We've seen strong performance against our clinical objectives for the first half of the year and we fully expect to continue this momentum in the months ahead.
I'd just like to take a moment now to recap the upcoming milestones that we are expecting later this year and early next year. First, we will present topline data from the Phase 2b STORM study in September 2016, at which point we plan to announce the next steps in our overall multiple myeloma development strategy.
Second, we will present near final Phase 2 SINE data in gynecologic malignancies at an oral presentation at ESMA in October. Third, we remain on target with patient accrual to SOPRA study in AML and the expected interim analysis of overall survival events is anticipated in late 2016. Fourth, we plan to present additional topline data from the Phase 1b portion of the STOMP study also in multiple myeloma in late 2016. Fifth, we plan to present topline KPT-8602 safety and tolerability data from the Phase 1 portion of this study in late 2016. And last, we continue to accrue patients to the SADAL study in DLBCL and we anticipate announcing topline data in early 2017.
Supporting all of this is a strong balance sheet which provides carrier off and the flexibility to pursue our clinical and corporate goals. We look forward to sharing with you these several key clinical data readouts through the remainder of the year, all of which bring us ever closer to our goal of bringing novel first-in-class medicines to patients with cancer. We look forward to keeping you updated on our progress.
With that, I'd like to open the call now for questions. Operator?
Thank you. [Operator Instructions] And our first question comes from the line of Brian Abrahams from Jefferies. Your line is now open.
Hi guys, thank you for taking my questions, and congrats on all the progress.
My first question is on the STORM study can you help contextualize the response rates and clinical benefit rates that you might expect to see in a similar population on either Pom or bortezomib alone plus Dex without selinexor?
Sure. The Pom population which is simpler to discuss, really met the study for Pom that is accelerated approval study for Pom, that is to say they had to have lenalidomide and proteasome inhibitor refractory disease and the expected response rate in combination with Dex is about 30%.
We were seeing, both deeper responses even though it was early in the study, there were some very good responses there, including I believe a complete remission as well as some other nice very quick PRs. So we are running at about twice the response rate you would except for Pom alone and the responses at least early on appear to be deeper, but we'll have to see because it wasn’t a lot of patients.
On the Velcade side, the patients with Velcade had ran a gambit including as you know 10 of the 16 patients were Velcade refractory. So the response rate expected in those patients is close to zero. Many of those patients had Velcade refractory disease or carfilzomib refractory disease where the proteasome inhibitor wasn’t their last regimen. So for most of the patients on that study you'd get very close to zero response.
For the other patients on the study, who hadn’t seen Velcade before, you typically would expect a response rate in the 30% to 40% range when you combine Velcade with dexamethasone. If you recall from the original Velcade accelerated approval study, Velcade alone it was a 28% response rate and if you add a little bit of steroid in that it can kick it up into the 30s, but typically in that range. So in both cases we saw very rapid responses and what appeared to be deeper and higher response rates.
Got it, that's very helpful. And then with the timelines now laid out for the STORM readout, can you remind us the level of detail we should expect to see? I mean would it be able in addition of response rates will we be able to see any interpretable PFS data and on the PFS front just wondering in penta-refractory population your sense - do you have any sense as to what the potential bar would be for approvability on an accelerated basis? I know usually six months is he bar, but this is such a sick population, what should we be looking for in that group on the PFS side?
Yes, so let's start with the first part which is what are we going to put out, we're going to put out very much just topline data which will be the response rate only and the reason for this is primarily protect the integrity of the data and bring it out at an appropriate medical meeting which we hope to do later this year. So you'll see a response rate we believe in this population that the responses - the best responses that have ever been reported in the quad population as we mentioned are 20% and 21% for the anti-CD38 molecules.
We are not aware of any studies to date in the penta-refractory group. So this will be the first glimpse of those data for us and we think for anyone. And we think that some response rate in the 20% range would be predictive of clinical benefit, but of course that would be an FDA review issue. So there will only be response rate at the topline data.
The plans going from there will be, we intend to outline the plans going from there we won't see any more about it today, but are plain in multiple myeloma which will incorporate both those data as well as the potentially full approval study which would be a randomized controlled study which we're planning to discuss a little bit on that call as well.
Just to be clear and I don't mean to pick words here, but just be careful, that what we're looking for is the response rate and then disclose later this year will be a duration of response not a progression free survival. PFS is different endpoint. You need to have durable responses.
You are right about six months typically, penta-refractory disease is a whole different ballgame and we think some number of months, but of course that also would be a review issue for the FDA. It would have to be some meaningfully along responses and we think something in the four to six-month range would be acceptable, but we don't really know.
Got it, that's very helpful and one more question if I may. Can you maybe just quickly talk about sort of the gating factors in terms of your decision whether or not to start the carfilzomib combo SCORE study?
Yes, we are currently still looking at the logistics of that study and the control arm et cetera and we plan to have an update on that in the next month as well and we're meeting with our key opinion leaders as well on how to best do that.
We're also intrigued, quite intrigued by the Velcade data that you saw very much confirms the carfilzomib data. So we're considering that in our plans to move ahead with selinexor in combination with a proteasome inhibitor in general and sort of doing a balancing act between carfilzomib and Velcade.
Thanks so much for taking my questions.
Thank you. And our next question comes from the line of Whitney Ijem of JPMorgan. Your line is now open.
Hi guys, thanks for taking the questions. I guess first quarter on STORM, in June you announced enrollment completion, you said data was on track from mid-2016. So I am just wondering has there been a little bit of a slip there or I guess and if so what was driving that?
Yes, we don’t consider September a slip at all. We think it is mid-year. The simple driver is that you enroll, finish your enrollment and we like to have at least three cycles of therapy with adjudication by the independent review committee reminding everybody that the data we put out will be clean data.
So first of all we have to go through data cleaning and then it will go through the four-person independent review committee for adjudication. So all the responses will have an IRC adjudication on clean data and that's what takes not only at least three cycles, but also the cleaning.
I should also mention that there are anticipated to be a number of patients that remain on study even when we announce the topline data and since topline data are best responses it is possible that those data could improve, but certainly they cannot get worse.
Got it, okay. And then in that trial you mentioned that switched from dosing three weeks out of every four-week cycled to the full four weeks. Can you just kind of talk about the decision behind that, was that driven more by, I guess maybe cleaner safety or just a desire for more efficacy or…?
So we will discuss this in more detail when we will present the data hopefully later this year, but in general, we have discussed this, this is the first study that was done in patients that are penta and quad-refractory and we have discussed it several times the investigators that are participating in the study as well as our key opinion leaders and you have to take into account the kinetics of the disease and the overall condition of the patients. And the dosing regimen now allow the physician full flexibility in controlling the disease as well as using dose breaks as they need to.
Thank you. And our next question comes from the line of Michael Schmidt of Leerink Partners. Your line is now open.
Hi, this is Jonathan Chang stepping in for Michael. Thanks for taking my questions. How should we be thinking about the upcoming SOPRA data in AML and SADAL data in DLBCL and what are the benchmarks there?
Yes, the upcoming SOPRA data will be in interim analysis and it will simply be a decision on what to do from that interim. It is one of these interims that allow modification of the study or early stopping rules. So the study could either be upsized, if it is on the right track, but we think we need more patients or there have been more dropouts for other reasons the study could be maintained as its. The study can be stopped for futility and the study can be stopped for overwhelming efficacy.
So the initial data you will see by the end of the year will simply be a decision based on the interim analysis. We don’t want to put the data into trouble by announcing any early data because you can always be accused if that would influence the outcome. The expectation is assuming we don’t upsize the trial substantially, we would have essentially final data, final topline data by mid next year on SOPRA.
On SADAL, we anticipate reporting response rates as top line data in early next year and later at a medical meeting we would have durability et cetera. The SOPRA trial is around going back to AML, the SOPRA trial is a randomized trial with overall survival as an endpoint. If the trial looks positive we will go to the regulatory authorities in U.S., Europe and Canada where we are doing the study and discuss potential for submission. If the SADAL trial achieves a response rate that we like and we think it is meaningful and our KOLs continue to support us we will also go to the regulators looking for an accelerated approval based on the response rate.
Great, thanks. Can you also remind us what the key differences are between 8602 and selinexor and how these differences might impact your development strategy and positioning for this program?
So I will answer the first part of the question. The two compounds are both XPO1inhibitors. They both bind through reversible coagulant bond to sustain five to eight and residue in XPO1, they are coming from different patents, so they are in terms of intellectual properties they are separated.
The main difference in, but they present the same mechanism of fraction, the main difference is that selinexor goes to the brain, hence our study in glioblastoma 8602 has minimal brain penetration in rodents and monkeys and dogs and we believe that based on the preclinical data that that should alleviate some of the side effects that are associated with selinexor including anorexia and fatigue. That allows us in preclinical model to dose five to seven days a week. So essentially almost every day and in the clinical study the Phase 1 clinical study we are dosing Monday to Friday of every week continuously.
Okay. Great, thanks.
And our next question comes from the line of Mike King of JMP Securities. Your line is now open.
Hi guys. Good morning. Thanks for taking my questions. Just a couple of quick followups. With regard to STORM, are you guys satisfied with the proportion of patients in the study that have relapsed from CD38 therapy?
Cell protocol we needed to have at least 25% of the patients being treated with an anti-CD38 or penta-refractory patients and we have 30 out of the 78, so we are satisfied as we met the goal that we put in the protocol.
Okay, great and then just continuing with anti-CD38 since we can't have a conversation with someone who treats myeloma these days without the subject matter coming up, I am just wondering, as you think ahead for new market uptake for selinexor in this setting any plans on the drawing board or any thought given to regimen or regimens that incorporate anti-CD38 therapy?
Yes, we are absolutely discussing that and planning that. We don't have anything initiated yet and as soon as it is we will let folks know. But I do want to broaden that answer a little bit. I think one of our goals in this and you’ve heard a little bit about the oral proteasome inhibitor, you've heard about Kyprolis, you've heard about combo of Velcade and Pom. Lenalidomide is accruing nicely now combination in second line myeloma. And many of our patients with Velcade also received the combination of second line myeloma.
So, one of the nice things about selinexor is it's just easy to give. It's an oral agent. You can take it home, and the data today suggests that it can be combined nicely with other drugs. Our view on myeloma is that this myeloma market is growing. Daratumumab is running at probably over $600 million this year, at least current run rate, Pomalyst is running at about a $1.4 billion run rate this year.
And part of this is because unfortunately none of these drugs cure the disease, but patients are living longer. So the opportunities for new drugs are actually increasing in this setting. And selinexor being easily added to other things being a completely novel therapy and being oral, we think has a remarkable opportunity in this disease depending on the outcomes of the data. And if the current data continue, we think that selinexor could be quite a good partner for a number of different therapies, not only CD38.
Thanks for that answer, Michael. So then moving quickly to AML, just to be clear, the update that you'll give will be looking at the OS correct?
Yes, but we'll give – the OS it will be assessed by a data safety, DSMB for the study as they continuously look at all of our safety and activity data. And there will be a decision based on the statistical analysis laid out in the protocol as to a recommendation the DSMB on whether to leave the study alone, modify it by upsizing it, or stop it for efficacy or stop it for futility. So we will give an update only on the action taken and then the topline data should be available by mid next year. We are very much on track with accrual.
Okay. All right. So we won't see any OS or CR/Cri rates or anything like that?
A - Michael Kauffman
We can’t get through the trial and we will hurt the trial and it will come under a lot of scrutiny if you give interim data.
Understood. I just wonder how you guys think about eventual advent of [indiscernible] in light of the improvement in OS and CR/Cri rates that they showed over 73.
Yes it's a great question, Mike and thanks for bringing it up. First of all to be clear, the SOPRA study in AML is in patients who are over 60 years old, who are not candidates for any chemotherapy or transplantation. So the population right now that we're looking at couldn't get [indiscernible] or at least that is certainly not the label. If they can get a chemotherapy agent they're actually ineligible for the study and almost all treating physicians would give a patient like that some kind of chemotherapy [indiscernible] or standard drug.
So it's a very different population. We are quite excited about the [indiscernible] data. As you are aware we've combined selinexor nicely with Idarubicin and [indiscernible]. We also have a front line study going on with daunorubicin and [indiscernible] and we hope to update those data in the near future. So there's a real opportunity here for selinexor to combine with [indiscernible] as well, but in a chemotherapy acceptable population of AML patients not the super group.
Thanks for taking the questions.
Thank you. And our next question comes from the line of Arlinda Lee of Canaccord. Your line is now open.
Hi guys, thanks for taking my question. I had maybe a clarification on the STOMP, sorry STORM study. You mentioned that the topline results we're going to get in September going to response rate and that you think that the duration of response of four to six months would be sufficient for an approval. So, I guess, I'm wondering by year end is that enough time to see that range of duration of response?
Yes, we're comfortable that dor [ph] will mature later this year and more importantly, in order to be acceptable for highlighting at a medical meeting et cetera, we don't want to give up all the major data and obviously response rate of the key major data, but durability is the other one and there'll be some other subset analysis and so on that will be provided in a medical meeting. So our goal is just not to harm the medical meeting output by giving just and we'll just give the response rate to do that, because we know that this is an important issue.
Secondly, just to keep in mind, we do not believe that 30 patients with penta-refractory myeloma is sufficient for an accelerated approval. Typically, recently accelerated approvals were granted in the 100 to 120 range, and we do intend to enroll approximately 120 additional patients with penta-refractory disease, if the data warrant that and that's only if the data warrant that we will discuss that later on in September when we have our results.
Okay great. And then, I guess I'm with 8602 data having topline data I guess later this year, how do you kind of see the myeloma space between selinexor and 8602?
Yes I think it’s, we're a bit ahead of ourselves. I think there's a lot of excitement about 8602 and like many drugs it certainly has stellar data in animals, particularly in rodents. But it's just undergoing a Phase 1 study now and we'll have some initial data from that Phase I study we hope by the end of the year in a medical meeting. That said, selinexor has been in over 1500 patients. We understand it. We understand how to combine it with lots of other different drugs.
So we're a little bit ahead of ourselves in terms of moving 8602 very quickly. We hope that the 8602 profile is differentiated as Sharon mentioned and once we have a clearer picture of that in humans, then we'll be able to talk a little bit more about the development pathway.
Great, thank you. And then maybe a last question on the STOMP study, what additional data are we expecting as opposed to EHA later on this year? Thanks.
So enrollment on the selinexor- bortezomibas well as the selinexor - pomalidomide has been ongoing, and we will update. We will have more mature data and lager number patients on both of these arms hopefully later this year, including it will make it into identification of the recommended Phase 2 dose for these combinations.
Okay. Thank you.
And our next question comes from the line of Chris Raymond of Raymond James. Your line is now open.
Hey, good morning. This is Laura Chico in for Chris Raymond. Thanks for taking the question. Michael, just a quick followup one, I think you just said that you needed, if the data warranted upsizing the STORM trial, that you would be looking for at least 120 more patients to enroll. Those would all be penta-refractory? And I guess, as you thought about it previously you had discussed having that expansion kind of complete enrollment by, like middle of 2017. If you had to enroll all penta-refractory patients would that change timing at all on that front?
Yes, I think first of all to clarify, if the data are reasonable and it looks like we have a short and accelerated approval is always a big hurdle, so we all need to remember that. The unmet medical need population is clearly the penta-refractory population. Daratumumab it's currently under an accelerated approval, but it will soon convert to a full approval and by the time we would submit any kind of accelerated NDA if the data warranted we would, dara would be fully approved.
So CD38 would become a standard-of-care officially. So the penta-refractory population is the unmet medical need population at the present time. We are working on the statistics right now, and we're just giving an approximate number of patients. I'm just saying that pomalidomide was approved, the Pom-Dex arm was about 110 patients and in the dara study, the Phase 2 study that was approved accelerated was just over 100 patients as well. So I'm just giving you numbers that have been used by other drugs.
Okay. And so that wouldn’t change your timing at all on completing enrolment for the next phase?
Yes, we will have to give more guidance on enrollment once we do all of our assessments and site checks. Obviously, no one has ever enrolled a large number of penta-refractory myeloma patients before as we mentioned the first 30 here are coming in to our knowledge this is the first time anybody will report on that. So, we need to learn a little bit more about that and what kind of timing we will expect and we’ll give you more detail as it is available to us.
Okay, sounds good and I guess just one quick follow up on SOPRA in AML, there was a paper that published earlier this year from a Swedish group that looked at elderly AML survival and kind of showed an increasing trend over time when you compared from the 1970s to today. I guess when you are thinking about overall survival response in AML do you see that trend also or is that kind of a one-off I guess kind of what it the baseline OS [ph] that we should be thinking about in an elderly AML population there?
Yes, it's a little tough to say and at this stage the patients that we're taking in SOPRA. SOPRA remember is in older patients over 60 who are not candidates for chemotherapy, but it is being done in second line. So that means the patients have to have failed at least one prior regimen and that includes a hypomethylating agent. The survival of patients whose disease has progressed after a hypomethylating agent or other agent in AML is not well published and our best estimates from the literature its, it remains about three months.
You are quite right that the overall survival might be increasing typically median survivals in elderly AML are quoted in the nine month range, sometimes it is low as seven months, sometimes closer to a year, but the second line treatment in elderly AML is very difficult to measure in its mattered, its less, it is well less than six months from the literature.
And I’m showing no further questions in the queue at this time.
Okay, thank you very much everyone for your interest in Karyopharm and for participating in our call today. We look forward to seeing many of you at upcoming medical and investor conferences. Have a good day.
This concludes today’s conference you may all disconnect.
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