Epizyme, Inc.
Q1 2017 Earnings Call Transcript

Published: 18 May 2017

[Operator:]

Good morning, and welcome to Epizyme's Solid Tumor Program Update Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session after the prepared remarks. Please be advised that this call is being recorded at Epizyme's request. I would now like to turn the call over to Monique Allaire with THRUST Investor Relations. You may begin.

[Monique Allaire:]

Thank you and good morning everyone. This morning, we issued a press release outlining interim data from Epizyme's Phase 2 study in solid tumors. The press release and the slides that we'll be using during today's call are available in the Investor Center of our Web site at epizyme.com. Joining me on the call are Rob Bazemore, Chief Executive Officer; and Dr. Peter Ho, Chief Medical Officer. Additional members of the Epizyme team will join us for the Q&A session. During this call, we will use forward-looking statements related to Epizyme's current expectations and plans, which are subject to risks and uncertainties. Actual results may differ materially due to various important factors, including those described in the Risk Factor section of Epizyme's Form 10-Q filed in May. These statements represent our views as of this call, and should not be relied upon as representing our views as of any date in the future. We undertake no obligation to publicly update our forward-looking statements. Let me now turn the call over to Rob.

[Rob Bazemore:]

Thank you, Monique, and good morning everyone. At Epizyme, our vision is to rewrite cancer treatment through the development of epigenetic medicines. We are pioneers in this area, and tazemetostat, our lead investigational treatment is a good example of our efforts. As a reminder, tazemetostat is an orally-administered molecularly-targeted first-in-class EZH2 inhibitor. We're happy to update you on the progress that we've made with our overall tazemetostat clinical program, and inform you about our productive meetings with the USFDA. For today's call, we'll be focused on our solid tumor program. As a reminder, interim Phase 2 data on tazemetostat in follicular lymphoma and DLBCL will be presented at ICML in just a few weeks. In December of 2015, we initiated a Phase 2 clinical trial evaluating tazemetostat as a treatment for a specific set of molecularly defined solid tumors based on loss of the INI1 protein. This study has been enrolling patients into five cohorts; for those with epithelioid sarcoma, synovial sarcoma, renal medullary carcinoma, malignant rhabdoid tumors, and lastly, a basket cohort for all patients with other INI1 negative tumors that are not one of the previous four histologies. For today's call, Peter will review the interim data from the epithelioid sarcoma and synovial sarcoma cohorts, which will be presented during ASCO. The remaining three arms of the trial have not yet reached the pre-specified utility assessment by the Independent Data Monitoring Committee. As such, we plan to report updates from those cohorts later this year. We'll also provide an update following our recent meeting with the FDA. The agency was supportive of the development of tazemetostat for epithelioid sarcoma or ES. We are delighted that we have identified a regulatory path to bring tazemetostat to patients with this ultra-rare cancer. Notably, this path supports potential submission for an accelerated approval based on our Phase 2 trial, which is currently ongoing. Tazemetostat has demonstrated clinically meaningful activity in ES, measured by durable disease control and objective responses in the Phase 2 trial. It's also demonstrated a favorable safety profile, consistent with the experience across the tazemetostat program. This study cohort represents the largest prospective study of ES of either an investigational or an approved treatment. Due to the rarity of this aggressive cancer and the limitations of current therapies, we believe that we have a unique opportunity to make an important difference for patients, which ultimately is the goal of Epizyme. Let me hand the call over to Peter to walk through the data.

[Peter Ho:]

Thanks, Rob. Starting on slide four, we're very pleased with the interim findings from our Phase 2 study. Before reviewing the data, let me provide some background information on ES. This is an ultra-rare soft tissue sarcoma that is characterized by a loss of the protein INI1. ES is an aggressive cancer with a high rate of local recurrence and distant spread via either the bloodstream or the lymphatic system. Tumors can present as painless masses anywhere in the body. Sites of disease can range from the extremities, such as the hands and legs, to the trunk of the body, including deep in the pelvis or on the chest wall. The lungs and liver are the most frequent sites of metastases. Patients with ES are most commonly diagnosed as young adults, often between 20 and 40 years old, although children and older adults can develop these tumors. There is a two-to-one predominance of males to females. ES becomes more aggressive after recurrence from metastases, with a typical survival of only eight to 12 months for patients with metastatic disease. There is no currently approved systemic therapy indicated specifically for ES, and no established standard of care. When patients are diagnosed with localized disease surgical resection, including amputation of limbs is performed. Patients who develop an unresectable recurrence, or who present with metastatic disease, are often treated with chemotherapy or investigational agents. While doxorubicin and prednisone [ph] are approved therapies indicated for the treatment of soft tissue sarcomas, based on the feedback we've received sarcoma oncologists view these treatments as having limited benefit of patients with ES. Soft tissue sarcomas represent over 50 different subtypes, including ES. As a result of this heterogeneity, the response of specific subtypes to available therapies will vary due to their underlying biological differences. In addition, doxorubicin is associated with challenging adverse events, such as myelosuppression and acute and chronic cardiotoxicity. Although sarcoma physicians do use these drugs, they convey to us that they primarily do so because there are few other treatment options for their ES patients. Patients with ES are treated in a variety of ways. As seen on slide six, this was the case with this 53-year-old woman, who participated in our Phase 2 study. At baseline, she had chest wall lesions, as seen in the left-side panel. This patient was diagnosed in 2013, and was initially treated with epirubicin and ifosfamide. From there, she went on to have surgical resection, including a wide excision of her right dorsal forearm, followed by radiation. In 2015, she recurred with metastatic disease, but progressed through combination chemotherapy with doublets of epirubicin, ifosfamide, gemcitabine, docetaxel, and vinorelbine. She started tazemetostat in May of 2016, with disease in her chest wall, back, right forearm, and lung, where she had multiple lesions. After eight weeks, the lesions were considerably smaller, and the patient met criteria for a partial response. With continued treatment of tazemetostat her lesions further decreased. And as of her last scan, at nine months, she has had a nearly 80% reduction in tumor burden. Her response remains ongoing, and we are following this patient as she continues on treatment today. So far, the ES cohort has enrolled 49 out of the projected total of 60 patients. As a reminder, the cohort was initially designed to enroll 30 patients, and we expanded to enroll an additional 30 patients in December of last year based on objective responses observed. The data we'll discuss today, and that will be presented at ASCO, are on the 31 patients from the initial study group as of the data cutoff on May 1st, 2017. On this table, you can see a breakdown of the ES patient demographics from our Phase 2 study. The median age is 33. And a male predominance of approximately 2

[Rob Bazemore:]

Thank you, Peter. As I stated earlier, we recently met with FDA to discuss the registration strategy for tazemetostat at ES. We are appreciative of the collaborative discussions that we had with the agency. Through their dialog, we identified a registration path for submission for accelerated approval based on the current Phase 2 study of 50 patients. And if successful, we will target submission of our first new drug application in 2018. As with all submissions, it will be subject to FDA review and confirmation that tazemetostat has demonstrated a compelling benefit risk profile for the patients indicated in the label. We believe this to be true, and we look forward to advancing that submission. I am incredibly proud of the work by our clinical and our regulatory teams as well as the entire Epizyme organization in getting us to this point. 2017 is a transformational year for the company. In addition to our work with tazemetostat, we are on track to name the next development candidate from our epigenetic portfolio later this year. We look forward to telling you more about this program at that time. Looking out a bit longer term, we are targeting an NDA submission for ES in 2018. This is a critical step to achieving the first element of the four key transformative goals in our vision through 2020, bringing tazemetostat to the patients with solid tumors, follicular lymphoma, and diffused large B-cell lymphoma. Second is to execute a broad clinical program for tazemetostat that will support its expansive use in both early and late lines of treatment as a monotherapy and in combination with other anti-cancer agents in a range of cancer types. Third is to build a robust pipeline with at least three new product candidates in clinical development. And finally, if we've achieved all of this we will have further established our epigenetic leadership through continued innovation. This is a very exciting time for Epizyme as we work to execute on our vision for the future. Before we open the call for Q&A, let me just close by thanking the physicians, the nurses, and the medical staff for their continued enthusiasm and efforts in helping advance tazemetostat. Most importantly, we'd like to extend our sincerest gratitude to all of the patients as well as their families and caregivers who are making a significant contribution to our industry by participating in our clinical trials. Without you, we would never be able to make the important medical advancement that we believe will allow us to rewrite the way cancer is treated in the future. With that, we'd be happy to take your questions.

[Operator:]

Thank you. [Operator Instructions] Our first question comes from the line of David Nierengarten with Wedbush Securities. Your line is open.

[David Nierengarten:]

Hi, thanks for taking my questions. I just had a couple, first off, if you could be maybe a little bit tighter in the guidance on NDA submission in 2018. And then also, if you had plans, now that you have an initial indication that you're looking for approval if you had plans to follow-up maybe on the other solid tumor indications with either post marketing studies, or, I guess, there would be also Phase 3 studies on other combo agents in the solid tumor setting. Thanks.

[Rob Bazemore:]

Previously, we've expressed 2018 as a potential earliest possible launch time for tazemetostat. Now what we're doing is with our guidance, we're focusing our guidance on what we can control, which is the submission of the NDA. Ultimately, the acceptance of the NDA, the timing for the review and approval are all at the discretion of FDA. But we believe based on being able to file on this Phase 2 study of 60 patients, as you heard Peter describe in his presentation, we're now at 49 of those 60 patients. We fully believe that we'll be able to submit an NDA in 2018. As for data on other cohorts or being able to expand the label, this discussion focused primarily on epithelioid sarcoma because it's the cohort where we're the furthest along and we have the most data. And Peter said on the call, we are seeing clinical responses in other INI1 negative cohorts. We're also seeing responses in our pediatric solid tumor study. And obviously, our goal would be to have the broadest possible label that we could to cover both adults and children with these INI1 negative tumors if our data support.

[Operator:]

Thank you. Our next question comes from the line of Mike King with JMP Securities. Your line is open.

[Mike King:]

Good morning guys, thanks for taking the question, and congrats on the data. Can you hear me okay?

[Rob Bazemore:]

We can, Mike.

[Mike King:]

Okay, sorry, just had a little trouble queuing in, so I just want to make sure my line is clear. I just wondered if you could tell us what, in terms of response rates, if there was any influence by the number of priors. I don't know if you helpfully [ph] list the number of priors in the patient demographics, but I'm just curious as to whether you can tell us more about the response rates based on prior therapy or lack thereof. That's my first question.

[Peter Ho:]

Yes, sure, Mike. This is Peter, thanks for the question. It is a very interesting one in the sense that for epithelioid sarcoma there's really not a lot of literature out there on it. And so as we look at it in the experience we have thus far, and we'll continue looking throughout the entire study, but it does not appear thus far that the number of priors makes a significant difference with respect to the activity that we're seeing for tazemetostat. If you look at the patients who've had an objective response or whether you look at the patients who have had stable disease for eight months or more. Both of those are the two components of disease control as we've defined it. It's fairly evenly spilt between patients who've had no prior therapy as well as multiple prior therapies. And we're not talking just one or two, as you can see in the patient profile, that some of the patients have had three, four, and more prior therapies. I think that's reflective of the fact that epithelioid sarcoma as one of the subtypes of soft tissue sarcoma appears to be particularly resistant to available therapies such as cytotoxic chemo therapies and other therapies. So if that is the case, and we believe it is; that would contribute to not seeing a significant difference in responsiveness as you go further down the line, different from other more common tumors, such as breast cancer, for example.

[Mike King:]

Right, okay, it's very encouraging. And then just as far as the -- remind us, Peter, on the Phase 1 patients that you describe on slide nine, whether those had -- that the two durable responses, were those responses, or stable disease, or some mix of the two?

[Peter Ho:]

Sure. So those two baseline patients both had prolonged stable disease. Their tumors did not [indiscernible] efficiently to meet resist criteria for a PR, but the durability of their response really is quite impressive. And I really -- it's important insight. These patients did have disease progression prior to coming on studies, so it wasn't like their disease was just sort of smoldering. They were progressing through prior treatments before coming on to tazemetostat.

[Mike King:]

Okay, great. And then one -- finally, the one patient that you described that one-off study for definitive surgery, was she the only one that was able to do that or were there other cases of that as well? Or other surgeries performed where the tumor mass was reduced by resection?

[Rob Bazemore:]

So, Mike, that patient has been the only one who has elected to come off for an elective surgery. The other patients who have had responses, there are two patients who remain in response with the tumors continuing to shrink. One patient, as you can see on that swim lane plot did have a response through 48 weeks before progressing.

[Mike King:]

Thank you for taking my questions.

[Rob Bazemore:]

Sure.

[Operator:]

Thank you. And our next question comes from the line of Robyn Karnauskas of Citi. Your line is open.

[Unidentified Analyst:]

Hi guys, this is [indiscernible] on for Robyn. Robyn is still on maternity leave, but she says hello and congratulations on the data. Good morning. So, one of the questions I had was about your discussions with the FDA, can you provide some more clarity on whether you talked about a post marketing plan, what the expectations are? Have they set a bar for efficacy and safety in that setting? Is it similar to what you have right now, or if not now, when can you provide more details on that?

[Rob Bazemore:]

Well, first of all, let me talk about the bar, and then I'll talk about the discussions as it relates to any other commitments to accelerate approval. First of all, as Peter said, there aren't any other therapies today that are currently approved specifically in epithelioid sarcoma. And as he described when he talked about the experience of patients coming into our study, the drugs that clinicians use today, they often tell us that they use them because it's all that's available, not because they actually work in this disease. And so there really isn't a bar that the FDA established with us. I think what they're looking for that was clear in our conversation is that they want to see a clinically meaningful benefit in these patients, and they want to see a totality of the evidence in those particular endpoint, as an example, response rates are often times used [indiscernible] is often times used in solid tumors as a way of evaluating responses. But if those responses aren't durable, if they don't last for a long period of time they don't really mean anything. And so I think what we discovered in talking with them is that they're going to look for a totality of the evidence. And that's the reason we're collecting duration of response, PSS, OS, we're collecting a number of these endpoints in the study. And based on what we're showing in the first 31 patients, we believe that we'll be able to demonstrate an impressive totality of evidence. In terms of the actual conversation with them, we're not getting into a lot of the specifics other than to say that the pathway to submission for an accelerated approval will be based on this study, the Phase 2 study. And be based on the cohort of 60 patients. We did have a conversation with them around the confirmatory study. As you know, any accelerated approval carries with it the obligation to do a confirmatory trial. And so we did discuss a protocol with the FDA. There's a bit more work to do on that, but we'll be working with investigators to finalize the protocol. And as soon as we can, and we've announced -- and we've gotten to the finalization of that protocol and are ready to initiate it we can give you an update. Peter, I don't know if you want to say more than that on the confirmatory job?

[Peter Ho:]

No.

[Rob Bazemore:]

Okay.

[Unidentified Analyst:]

Okay, great. Thank you so much.

[Operator:]

Thank you. Our next question comes from the line of Phil Nadeau with Cowen and Company. Your line is open.

[Phil Nadeau:]

Good morning. Thanks for taking my questions. First, a question on slide 10, where you show the separation between those patients who have disease control versus non-disease control, I guess, to kind of put that slide in perspective, could you discuss the natural history of these patients and the disease a bit more generally. So, were all patients progressing rapidly upon study entry? And in the natural history of epithelioid sarcoma, is it ever possible to have disease control or a smoldering disease for a period of time?

[Peter Ho:]

Yes, thanks, Phil, it's Peter. So, all good questions, and we are looking at all of the patients in terms of how they've done on their prior therapy. And the vast majority of patients have had progression prior to coming on treatment. Actually, as we move further into the study with these second 30 patients, we are taking greater efforts to have that documented very clearly from our investigators. But looking at the first 30 patients we have seen that. And in fact, in the patients who have responded who have had prior therapies they have been resistant to treatment. The natural history is I think if one takes a look at the literature and that there isn't a whole lot out there. Certainly the patients or should they present with localized diseases, as mentioned, it's novel control is what is undertaken in these in the form of a surgery, and it can be a drastic surgery with amputations, and even radiation. But really it's when patients present with metastatic disease, and there are patients in our study who have presented with metastatic disease or the patients' progress from local treatment to metastatic disease that the disease becomes much more aggressive. And what we've seen in the literature, sparse as it is, is that the overall survivals for patients who have a metastatic disease is generally on the order of 10 to 12 months. So that's pretty aggressive at that point.

[Phil Nadeau:]

Got it, okay. Did the FDA, in your discussions, as you to better characterize the natural history of the disease or do you feel like the FDA has a good understanding of what the disease progression typically is?

[Peter Ho:]

Well, I thinks it's not so much FDA, but that all of us, including some of the treating physicians who see the patients. Epithelioid sarcoma has not been well studied, so I think it's helpful for the entire community of ourselves, as sponsors, patients, physicians, and regulators to gather more information on that. And we know that there are efforts ongoing by various groups internationally to characterize their historical experience with epithelioid sarcoma. And I think that would be very helpful as we move forward.

[Phil Nadeau:]

Great. And then second, just as on the essence in prevalence of epithelioid sarcoma, I think in the [indiscernible] it's a rate of less than 1%-ish soft tissue sarcomas. I believe there's about 12,000 of those each year in the U.S., which suggests that there's maybe a hundred new cases of epithelioid sarcoma each year. Is that accurate, and if so, like you're going to enroll 60 in this trial, you're basically enrolling two-third of the U.S. population.

[Peter Ho:]

Yes, Phil, it certainly might seem that way based on the limited statistics out there. So we cite what has been reported. But I think it's important to understand that our belief is that the diagnosis of epithelioid sarcoma is it's underdiagnosed now. I'm not going to say that it's underdiagnosed by a hundred fold or something like that, but the molecular characterization of this disease based on INI1 loss is a fairly recent phenomenon. But it is being adopted at centers who see these patients. That being said, I think it may be a similar situation to, for example, another sarcoma that folks know about, and that's GIST. GIST was quite unknown to many in the community beforehand. There was no clear diagnosis for it, and there was no good treatment. With the advent of INI1 loss as a diagnostic test that for epithelioid sarcoma and what we think is the treatment in tazemetostat for epithelioid sarcoma. We think that the numbers will be higher than simply 1% of 12,000. How much higher that's going to go, we don't know. But certainly our belief is that based on our accrual of patients in the U.S. that there should be more patients out there than what those calculations would lead you to believe.

[Phil Nadeau:]

Got it. And then one last question, just kind of again looking at history, I know you said that the FDA wants you to find it or wants to prove the drug based on the finding of positive benefit risk in a population where there's really no good therapies. Are there other instances in the past where a similar secret situation has existed, and therapies of approximately a 13% response rate and 32% disease control rate have met that bar for the FDA? Basically, are there proxies where this type of data has gotten drugs on the market in the past?

[Peter Ho:]

So one example, Phil, is if you look at soft tissues sarcomas in general, that these are a group of tumors unlike, for example, breast cancer or, let's say these days, melanoma, where high response rates are not commonly seen at all. So, for example, prednisone [ph], a drug that I worked on in a prior life, is approved for soft tissue sarcomas, and ultimately was approved with a response rate of 4%. Obviously, one can't tell much from a response rate of 4%. So I think what that is informative of is that the clinical community as well as regulators recognize that response rate in and of itself is not as good a surrogate for clinical benefit as it might be for other diseases. And so time-dependant endpoint, such as PFF, such as duration of response, such as of course overall survival will become more important in assessing clinical benefit especially for patients with soft tissue sarcomas.

[Phil Nadeau:]

Got it. Thanks for taking my questions, it's very helpful.

[Peter Ho:]

Sure.

[Operator:]

Thank you. Our next question comes from the line of Geoffrey Porges with Leerink Partners. Your line is open.

[Geoffrey Porges:]

Thanks very much for taking my questions. First, could you just clarify what the number of patients from the original 31, and then of the total 49 still on treatment is? And then could you give us a little bit more information on the recruitment for the other INI-negative solid tumor cohorts, particularly when you expect to get to the futility analysis hurdle, and the decision on whether to go ahead? And then lastly, you've had the 30% disease control rate hurdle for the ES cohort, and you were over that hurdle, and proceeded. And we're right at that hurdle for synovial sarcoma, and didn't proceed. Should we assume that there's a 30% disease control rate hurdle for the other cohorts, and indeed is that the right hurdle in NHL in those subtypes as well? Just trying to figure out how you're making the decisions to proceed. Thanks.

[Peter Ho:]

So, Phil, maybe let me take this in somewhat in reverse order, and I'll try to get all your questions, but you may have to remind me of some. But to your last question, so with respect to translating particular disease control rate hurdles to NHL, we certainly wouldn't want you to think that that's the way we're thinking about the disease. And NHL is NHL, and there are different criteria, standards, and expectations for clinical activity there. With respect to the differences between epithelioid sarcoma and synovial sarcoma, so I think it's for synovial sarcoma the primary endpoint there was disease control at 12 weeks. And that's based on very good literature. There's a much larger body of literature on synovial sarcoma. But that is at a point of 12 weeks, so roughly three months. The criteria we use for epithelioid sarcoma, we purposely chose for stable disease, actually a more stringent criteria. So for patients to meet disease control for epithelioid we chose as a lower limit eight months. And that was based on taking a look at the available literature both for ES and for soft tissue sarcomas, and taking into account findings that stable disease for six months or more appear to be correlated with having clinical benefit from the standpoint of overall survival. So we wanted to be more stringent than that, and so we went and used eight months instead. So it's an issue of durability, because yes, our -- for the first 31 patients for epithelioid sarcoma our disease control rate is 32%. And we've said its disease control is 30% for synovial sarcoma. But that doesn't take into account the different durations, right. So for synovial sarcoma it was at 12 weeks only. For epithelioid sarcoma it's 32 weeks or more. And of course, when you take a look at our swim lane charts you can see that many patients remain in disease control well beyond 32 weeks, especially when you take a look at the Phase 1 patients. And so that's a different picture than what we see in synovial sarcoma. And I wouldn't want to necessarily equate those two and extrapolate that to the other INI1 negative tumors.

[Geoffrey Porges:]

Okay. And, Peter, could you just help us understand the number of patients out of the 31 still on treatment, and then the number out of the total 49 on treatment?

[Peter Ho:]

Yes, fair enough. So, if you go back to the swim lane chart you'll see that of the initial 31 patients that we're reporting on now there are eight patients who remain on treatment, two of whom have objective responses, and all six of the stable disease patients that met ECR criteria, in other words, all six of the patients who went beyond 32 weeks, so eight out of 31. We're not yet reporting on the second group of 30 patients as yet. And we look forward to updating that in the future.

[Geoffrey Porges:]

Okay. Thanks very much.

[Operator:]

Thank you. Our next question comes from the line of Peter Lawson with SunTrust. Your line is open.

[Peter Lawson:]

Hi, Peter. Congrats on the data. Do you have any patients that were in stable disease or partial response that are metastatic with distal disease?

[Peter Ho:]

Yes, we do, Peter.

[Peter Lawson:]

And what's the proportion of those?

[Peter Ho:]

I would have to get the precise numbers for you, but I do know that the responses in stable disease patients that we have are not necessarily restricted solely to the patients who have clinical distal variant epithelioid sarcoma, and certainly not too proximal of a variant only. It's a mix of both. We don't see a significant difference in the responsiveness to tazemetostat depending on whether patients with ES have the distal or the proximal variant disease.

[Peter Lawson:]

Great. Okay, thank you. And then are you getting a better idea of which patients respond to tazemetostat either in the INI tumors or the DLBCL?

[Peter Ho:]

Well, I don't want to be speaking about the lymphoma experience today. We'll be reporting that out at Lugano, and so we look forward to speaking to it there. For the other INI1 tumors, we're still looking at that, and obviously, very interested in identifying other biomarkers for sensitivity. We have reported out on the other cohorts besides epithelioid and synovial, but that is an active area of our evaluation.

[Peter Lawson:]

Got you, thank you. And then, Robert, do you think you can get a launch with ES in 2018, or is that more likely a 2019 event?

[Rob Bazemore:]

Peter, so I think what we're trying to guide to now is more of the submissions state, the submission of the accelerated approval. We feel very confident, and believe [indiscernible] as we said; we think that we could file for an accelerated approval based on this study, the Phase 2 study on 60 patients, of which we've enrolled 49 to date. So we feel very confident that we'll be able to make the [indiscernible] filing date. Obviously that discussion, and as a matter of time that it takes for the FDA to review files, approve a file, and I would just prefer that we guide on what we can control, which is the NDA submission.

[Peter Lawson:]

Got you. And this is the final question; it's kind of a follow-up from a couple of other questions around this; how many epithelial sarcoma patients do you think there are just based upon your experience, enrollment, and conversations with investigators?

[Rob Bazemore:]

Well, I think as Peter had alluded earlier, I think that the couple of things we know about it is this is a rare tumor. And I'll just -- I'll put the program in perspective overall. We have a very broad development program across non-hodgkin lymphoma, DLBCL, and follicular. This represents an ultra-rare disease with a high level of unmet medical need. As Peter said, it's about 1% of all the soft tissue sarcoma [indiscernible] existing literature but that literature has been fairly sparse. And given that many centers don't routinely test INI-1, the academic centers do but not the community centers because up until now without an approved drug to treat these patients who had epithelioid sarcoma, there really has been no reason to test for it. And so, we believe that the number that's published in the literature [indiscernible] if anything under represents the number of real patients. Just for perspective and I will add this to Peter's answer earlier, we know that synovial sarcoma as an example is a much larger group of patients. It's about 2000 patients diagnosed annually. And we enrolled this study cohort at the exact same rate that we enrolled the synovial sarcoma cohort. And so, it gives us a reason to believe there probably are more of these patients in the epidemiology which suggest that for us it's putting in perspective epithelioid sarcoma is an early-to-market opportunity to provide tazemetostat to patient that would benefit.

[Peter Lawson:]

Great. Thank you so much.

[Operator:]

Thank you. And our next question comes from the line of Matthew Eckler with RBC Capital Markets. Your line is open.

[Matthew Eckler:]

Hey, good morning. Thanks for taking the question. So I just wanted to ask based upon the data we've seen today, what your thoughts are about how tazemetostat will be positioned for the treatment of the epithelioid sarcoma? Are you thinking this a frontline therapy?

[Peter Ho:]

Yes, thanks, Matt. Peter here. In our discussions with investigators, we've really had a lot of enthusiasm based on the trial results. We've seen already investigators putting their patients -- some of their patients who are on trial are those who have had no prior systemic therapy before. And again I think is more reflective of the current landscape for other treatments. So we feel that this tazemetostat can certainly be used in a frontline setting again in the absence of other better therapies which seems to be the case there now. So in terms of positioning the drug, hard for me to say [indiscernible], but I can speak for our investigators, we are very willing and enthusiastic to use tazemetostat on the epithelioid sarcoma patients as early as possible.

[Rob Bazemore:]

And Matt, I could speak to that question from the standpoint from a labeling point of view, obviously the label is ultimately up to the FDA, and this will be a part of our review and approval process, certainly [ph] we talked about there being no available therapies -- no approved therapies specifically in epithelioid sarcoma that is in both [indiscernible] refractory setting as well as in the frontline setting. And as Peter said, we are enrolling both types of patients into our study. We're seeing responses in both the frontline patients and the less refractory patients. So that would be our intent.

[Matthew Eckler:]

Okay. Okay. Great. And then, any plans to initiate discussions in the EU?

[Peter Ho:]

Yes, Matt, absolutely. A good number of patients on our study are from EU now. So, we will be definitely be moving in that direction. As Rob mentioned, our initial discussions have been with FDA, but we are definitely looking beyond the shores.

[Matthew Eckler:]

Okay. Thanks.

[Operator:]

Thank you. And we have a follow-up from the line of David Nierengarten with Wedbush Securities. Your line is open.

[David Nierengarten:]

Hi, just a quick follow-up. I am sure it's a little early to be discussing this. But, are any updated thoughts on pricing strategies for solid tumors versus lymphomas? Are you looking to more likely have a unified price [indiscernible]? Thanks.

[Rob Bazemore:]

Thanks, David, interesting question. And obviously we are not commenting on price at this time. One of the things that epithelioid sarcoma does for us because it's a rare tumor type where there is not many drugs to benefit these patients is it does help us build a much stronger value proposition for the molecule. But pricing ultimately is dependent upon a number of things including ultimately where our label looks like, the timing difference between the launch and epithelioid sarcoma versus the lymphoma indications. There are number of things what the market conditions would like at that point of time, so there are number of things that play into it. So we wouldn't guide on price at this point.

[David Nierengarten:]

Understood, thanks.

[Operator:]

Thank you. And I'm showing no further questions at this time. I would like to turn the call back to Mr. Bazemore for closing remarks.

[Rob Bazemore:]

Okay, thank you very much, and thank you all for joining the call today. Thanks for being with us. We are very excited about where we are as a company. As you've heard from Peter, we've demonstrated a clinically-meaningful benefit with tazemetostat on patients with epithelioid or sarcoma based on a number of parameters. We recently had a productive meeting with the FDA to find the path towards submission of accelerated approval. This is an area where there is a clear medical need. We stand there with a line of sight to submitting an NDA in 2018, and this will be an important first to market opportunity for tazemetostat. We are financially strong with a cash runway into the third quarter of 2018, and we have a robust set of additional milestones coming up this year starting with the presentation of our non-hodgkin lymphoma data at ICML in just a few weeks. So, this is a great time for Epizyme, and we thank you for joining the call.

[Operator:]

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone have a wonderful day.