Epizyme, Inc.
Q2 2018 Earnings Call Transcript

Published: 2 Aug 2018

[Operator:]

Good morning, and welcome to Epizyme’s 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, this call is being recorded at Epizyme’s request. I would now like turn the call over to Jason Fredette, Vice President, Investor Relations. You may begin.

[Jason Fredette:]

Thank you, operator, and good morning, everyone. Earlier today, we issued a press release summarizing Epizyme’s second quarter results and recent business updates. This press release is available on the Investor Center of our website at epizyme.com. On the call with me today are Epizyme’s CEO, Rob Bazemore; and our Chief Business Officer, Susan Graf. Other members of the Epizyme team will join us for the Q&A session. Before we begin, please note that our discussion today will include forward-looking statements related to Epizyme’s current plans and expectations, which are subject to certain risks and uncertainties. Actual results may differ materially due to various important factors, including those described in the Risk Factor section of our most recent quarterly report on Form 10-Q. This document can be accessed on epizyme.com or on the SEC’s website. Forward-looking statements represent our views as of this call and should not be relied upon as representing our views as of any subsequent date. Please be advised that we undertake no obligation to publicly update these statements. And now, let me turn the call over to Rob to begin today’s discussion.

[Rob Bazemore:]

Thank you, Jason, and good morning, everyone. At Epizyme, our vision is to rewrite the treatment of cancer and other serious diseases through the development of novel epigenetic medicines. We are pioneers in this field, leading the way with our investigational treatment tazemetostat, a first-in-class oral inhibitor of EZH2 being evaluated for the treatment of hematological malignancies and solid tumors, as both a monotherapy and in combinations. We believe strongly in tazemetostat’s potential to treat patients with a range of cancers. Epizyme’s ultimate goal is to bring medicines to patients that will make meaningful improvements in their lives. We have a clear set of strategic portfolio priorities that are driving our focus and our financial discipline for both the near and longer-term. The first of these priorities is advancing tazemetostat development as a monotherapy in our two lead indications; epithelioid sarcoma and follicular lymphoma, utilizing the multiple accelerated approval opportunities, we believe, are available to us. We are preparing for our first NDA submission in epithelioid sarcoma, a major milestone for tazemetostat and for our organization. And in FL, we are focused on defining our monotherapy registration path and initiating a combo trial. Our second priority is to identify additional strategic combinations and indications for tazemetostat to maximize its therapeutic potential. As we advance the development of tazemetostat, we learn more about it. And based on both scientific rationale and our clinical data, we believe tazemetostat holds the potential to be used in combinations with standards of care and other targeted agents in a number of different cancers. Our new Chief Medical Officer Dr. Shefali Agarwal will play a critical role in this front. We are very pleased to round out our strong and highly experienced management team with the recent appointment of Dr. Agarwal. She brings nearly 20 years of clinical experience to Epizyme, with significant late-stage oncology development expertise and a strong track record of FDA engagement, and she is joining us for the call this morning. Under her leadership, we intend to further build upon tazemetostat’s pipeline and the product value potential by defining the next set of tazemetostat combinations and indications to explore. Our third strategic priority is to advance our novel G9a inhibitor, EZM8266 in sickle cell disease. We won’t focus on this compound and others in our early stage pipeline on today’s call other than to note that they represent meaningful options in our portfolio. In the short-term, however, the single most significant objective we have is working with regulatory authorities to resolve the partial clinical hold on our tazemetostat clinical trials, which everyone at Epizyme is working diligently toward. So, let me start there. As a reminder, in the second quarter, we were informed by regulatory authorities that new patients enrollment in tazemetostat trials was being paused in the U.S., France and Germany. This was due to a safety report regarding one patient enrolled in the dose ranging portion of our Phase I pediatric, solid tumor study who developed the secondary case of T-lymphoblastic lymphoma or T-LBL. This child had metastatic poorly differentiate chordoma and entered our study with a poor prognosis, following several prior rounds of therapy. The patient was on tazemetostat for 15 months and achieved an objective response to this monotherapy. Following the T-LBL diagnosis, the patient discontinued tazemetostat and began a standard treatment for this type of lymphoma. And we are told, the patient is responding quite well. We have completed several key steps to address the partial clinical hold to reopen enrollment in our trials. These include working with our investigators to re-consent all patients. Our investigators have been very supportive and we’re not aware of any patient who has opted to discontinue treatment due to the safety report. Additionally, we have finalized the detailed evaluation of literature and available clinical data to better understand this case of T-LBL. We also proactively undertook and recently completed a comprehensive assessment of the safety data and clinical activity observed to-date with tazemetostat across clinical trials in both adult and pediatric patient populations. We have convened and consulted with a panel of external experts to review and validate these assessments. We plan to include this information in our response to regulatory authorities and utilize it to inform any potential changes that may be proposed to study protocols, which could include changes to the patient populations that we are investigating for treatment and how potential future secondary malignancies in our trials may be handled. Now that the work to define our scientific position is complete, we plan to engage further with the FDA in the weeks ahead to gain additional insight that will enable us to finalize our response to regulatory authorities. Once we have gained alignment with regulators in the U.S., France, and Germany, we anticipate that the partial clinical hold will be lifted and the enrollment process in those countries would be able to proceed. Now, let me review why we are optimistic about our prospects for tazemetostat in follicular lymphoma and the learnings we’ve gained about tazemetostat’s potential in diffuse large B-cell lymphoma or DLBCL. As you may recall, we’ve been conducting a large multi-cohort Phase II study evaluating tazemetostat’s activity in patients with relapsed or refractory FL and DLBCL. Two cohorts in this trial are investigating tazemetostat as a monotherapy in FL patients with EZH2 mutations and FL patients with wild-type EZH2. At EHA in June, we presented positive interim data from both of these cohorts. As of the May 1 date of cutoff, tazemetostat treatment resulted in a 71% objective response rate in FL patients with EZH2 activating mutations. An additional 21% of patients who had stable disease were still on tazemetostat therapy as of May 1 with an opportunity to achieve an objective response. Notably, all patients in this cohort achieved at least some reduction in tumor volume as the best response, which we believe to be very meaningful. The median progression-free survival was 49 weeks, and the median duration of response, as of the date of cutoff was 32 weeks. Both of these figures continue to mature, as the majority of responding patients were still on therapy and new patients were being added to the cohort. In FL patients with wild-type EZH2, monotherapy treatment with tazemetostat resulted in an objective response rate of 33%, with a substantial majority of patients achieving at least some reduction in tumor volume as the best response. We were pleased with this ORR but, what stood out for many at the Congress was the 76-week duration of response in these patients, which we believe is impressive for this heavily pre-treated population. This is a durability benefit that continues to mature with more than 50% of the responders remaining on therapy. Tazemetostat is also been generally well tolerated in these patients. Only 17% of evaluable patients experienced a Grade 3 or higher treatment-related adverse event, and only 6% of treatment-emergent adverse events led to discontinuations or withdrawals. We continue to be excited by these FL data. The response rate in patients with EZH2 activating mutations remained strong. Meaningful responses have been seen in patients with wild-type EZH2 and the durations of response in these heavily pretreated patients are still maturing. Once we have resolved the partial clinical hold, we plan to re-engage with FDA to define the registration path for the treatment of relapsed refractory FL. As you may know, FL and DLBCL are very different diseases, both in terms of their etiology and the treatment considerations upon progression. DLBCL is more aggressive and the disease is almost always treated with combination therapy approaches in all lines of therapy. In addition, the patients we have enrolled in our study are heavily pretreated and highly refractory to their previous treatments. In our Phase II trial, we’ve been investigating tazemetostat as a monotherapy in DLBCL patients with EZH2 mutations and patients with wild-type EZH2. We also have an additional DLBCL cohort in our Phase II trial that is evaluating tazemetostat in combination with the steroid prednisolone, in patients with wild-type EZH2. Based on a recent interim assessment of these three study cohorts, we have observed that tazemetostat is clinically active and generally well tolerated in the DLBCL patients. However, after taking into consideration the level of clinical activity in these cohorts along with input from clinical investigators and the evolving DLBCL treatment landscape, we have decided not to pursue a monotherapy path and that a combination other than prednisolone would be needed to advance tazemetostat in DLBCL. Patients with ongoing responses in these cohorts are able to remain on therapy. But we will not be enrolling additional DLBCL patients in our Phase II trial. We plan to report the findings from these cohorts at a medical meeting in the second half of 2018. While we know that treatments are not going to have the same effect in every indication, decisions like this one are inherently difficult. We are a patient-focused organization, but ultimately, we need to be guided by the science and the data. We believe that other tazemetostat combinations may be more effective in treating this aggressive tumor type. We already have two such combination studies ongoing and plan to evaluate other combinations in DLBCL longer-term. The first of our ongoing studies is evaluating tazemetostat in combination with R-CHOP as a frontline treatment regimen for high-risk DLBCL patients, with safety and tolerability serving as the primary endpoint for this Phase Ib trial. Since R-CHOP serves as a backbone therapy for many cancers, we believe this safety assessment may prove to be strategically important for Epizyme. Our partner, the Lymphoma Study Association or LYSA, expects to present the safety, tolerability and PK data at a medical meeting in the second half of 2018. And we plan to further engage with them to assess the potential of advancing to the Phase II portion of the study. The other combination study we have underway is investigating tazemetostat with Genentech’s checkpoint inhibitor, atezolizumab, in relapsed or refractory DLBCL. This is also a Phase Ib trial that has safety and pharmacokinetics of the combination serving as the primary endpoint, along with secondary efficacy endpoints. Data from this study are expected in 2019. Let’s now conclude with our nearest term registration opportunity. Our first planned NDA submission for tazemetostat for the treatment of patients with epithelioid sarcoma. ES is a rare, aggressive, soft tissue sarcoma. It is characterized by loss of the protein INI1. Patients with ES are most commonly diagnosed between the ages of 20 and 40, and once the disease becomes metastatic, survival is estimated to be only 8 months to 12 months. There are currently no approved therapies, specifically indicated for ES. And while there are agents that have been approved broadly for soft tissue sarcomas, physician feedback suggests these therapies; they have limited utility in ES. As a result, the need for new ES treatments remain quite high. In fact, tazemetostat has been granted a fast-track designation from the FDA for the treatment of ES patients who have progressed on or following an anthracycline-based treatment regimen. In 2017, we presented data from 31 patients in the initial cohort in our Phase II trial that showed tazemetostat monotherapy resulted in a 13% objective response rate in ES patients. We reviewed these same data with the FDA and identified a path for accelerated approval submission based on data from the full cohort of 60 patients, which has been fully enrolled. An interim assessment of data from the trial has indicated that the objective response rate in the full ES cohort has remained consistent with what was seen in the first 31 patients. In addition, the durability data continue to mature, which we believe will further support our NDA submission. An abstract with our updated data was just recently accepted for presentation at the European Society for Medical Oncology Congress or ESMO 2018. So, we look forward to sharing these updated data in October. From a regulatory standpoint, we are now planning to submit our NDA for ES in the first half of 2019. We believe this revised timeline will enable us to include more matured durability data in our submission package and more fully demonstrate the strength of the clinical benefit these patients are receiving. We also believe it will provide sufficient time to resolve the partial clinical hold, request and participate in our pre NDA meeting, and complete our submission. Preparing a robust submission is incredibly important to Epizyme, particularly as we intend to pursue a subsequent submission in follicular lymphoma. I am proud of the team’s efforts, which bring us ever closer to realizing tazemetostat’s potential in helping patients in need. As you’ve heard, we are focused on a clear set of strategic objectives and it’s important to ensure that we have the financial strength to fully accomplish them. So let me now turn the call over to Susan to elaborate. Susan?

[Susan Graf:]

Thanks, Rob. The details of our financial results can be found in the press release we issued this morning, but let me highlight just a few points. We ended the second quarter with more than $215 million in cash, cash equivalents and marketable securities. We recognized $12 million in revenue during the second quarter, based upon an anticipated milestone payment from GSK, which recently announced that it has now entered a Phase II trial with a PRMT5 inhibitor that was licensed from us. Our operating expenses for the second quarter were $42.3 million, of which $31.3 million was allocated for research and development activities and $10.9 million for general and administrative expenses. As we look ahead, we fully intend to maintain our financial strength to achieve the core tazemetostat objectives, Rob laid out earlier in the call and capitalize fully on our pipeline’s potential. We are maintaining strategic investments in areas that we believe have the most compelling near-term potential for value creation. These include investments in our follicular lymphoma and epithelioid sarcoma programs, strategic approaches to combination therapies, and the modest expenditures required to enter the clinic with EZM8266, our novel agents targeting G9a for sickle cell disease. We have made decisions to reduce our near-term spending in other areas. For instance; we have stopped enrolling new DLBCL patients in our Phase II trial worldwide, deferred investments in certain planned new tazemetostat studies, refined our tazemetostat manufacturing plans, streamlined our early stage R&D work, and minimized our discretionary G&A expenditures. The updates we have made to our operating model have enabled us to extend our cash runway by a quarter into the fourth quarter of 2019. It should also be noted that this guidance does not include the expected $12 million milestone payment from GSK that I mentioned a moment ago, or any other potential milestone payments that we may earn through established collaborations. Importantly, we continue to be well capitalized with a debt free balance sheet and multiple financing options available to us. I’ll now turn the call back over to Rob to close things out.

[Rob Bazemore:]

Thank you, Susan. A few years ago, we laid out Epizyme’s vision for 2020. This was a plan to build optionality and create value for Epizyme. It was about investigating tazemetostat as a monotherapy in multiple cancer types, about exploring its broader potential as a combination agent, and bringing new epigenetic treatments into the clinic. Today, we believe we have two near-term registration opportunities for tazemetostat as a monotherapy, based on compelling clinical activity in each indication. ES represents the first of our planned submission with an accelerated approval pathway, a major milestone for the company and a patient population highly deserving a targeted treatment options. FL represents a significant market opportunity in a large patient population that is known to have a high rate of relapse. We have multiple combination studies underway with tazemetostat and others that we plan to initiate. We have expanded our pipeline with our next HMT development candidate, EZM8266, which we expect to enter the clinic early next year. And partnering has been an important component of our corporate strategy and one that we continue to embrace as we grow our company. Epizyme is at the leading-edge of developing novel epigenetic treatments. Naturally, as pioneers in this space, we’re learning a lot as we go. We have developed a first-in-class molecule that is now the most advanced EZH2 inhibitor in the clinic, and we’re confident in tazemetostat’s potential to make a difference for many patients who need and deserve better treatment options. It is our goal to improve the lives of these patients and we’re committed to making the right, informed decisions, keeping you apprised of our progress. With that in mind, we’re ready to take your questions. Operator, would you please provide the instructions.

[Operator:]

[Operator Instructions] Our first question comes from Michael Yee with Jefferies.

[Michael Yee:]

Hey, guys. Good morning. Two questions, congrats on all the progress. Obviously, one is on the EZH2 follicular lymphoma mutant population, I think there’s a lot of focus on that. You had a data update recently on that. Maybe just, confirm for us your confidence on timing of completion enrollment in that cohort and the next steps from there. You made a comment about re-engagement with the regulator, so confirm and talk about your confidence on that. And then secondly, as it relates to the ES filing, you made a comment about moving the filing timing to first half 2019, with particularly a comment around the durability and some update there. I guess I’m not really sure why that would impact that I understand why – just clarify that, why that would be pushed out. Thanks.

[Rob Bazemore:]

Sure, thank you, Mike. Let me comment first on follicular lymphoma, your first question. So we were very enthusiastic about the data that we just recently presented at EHA. There were a number of parts of that that were important to us. One, we were happy to see that the response rate in the patients who have EZH2 mutations has remained high and we think, as we said on the call, there’s still opportunity for some of those patients with stable disease to continue to improve. We’re also happy to see that the response rate in patients who have wild-type EZH2 did improve as we expected from the last time we presented those data. Probably as important to that though is, it was important to see the durability data this time. We didn’t have that the last time the data was presented at ICML that we’re seeing very robust maturity of the durability data in both groups; both patients with wild-type and EZH2 mutant patients. So, in terms of our confidence, the data continue to look quite strong. We’re very excited about our program in follicular lymphoma and our priority is, as soon as we’re able to resolve the clinical hold, re-engaging with the FDA to talk about a potential path to registration in patients with FL. There is nothing that says, we can’t have that discussion while you’re under clinical hold, but we actually think, first of all, from our prioritization point of view, it’s important we resolve the hold first and we like to have that done before we re-engage with the FDA, but that becomes then our next priority. With regards to the epithelioid sarcoma program and the change in the timing of the NDA, it’s really – it’s related to two things. The first you mentioned, which is the durability in the patients that are being treated. We know from our end of Phase II discussion that we had with the FDA last year that the totality of the evidence will be important as we bring forward this new program and a new indication in epithelioid sarcoma, particularly because this is the first filing for tazemetostat for any indication. And so, we think it will be important to show robust not only objective response rates, but also durability, because in the drugs that are used to treat those patients today, they’re characterized by low response rate but they are also characterized by relatively short duration of benefit. So we think that’s an important benefit to patients. It’s also important to be able to demonstrate to regulators. And by filing in the first half of next year, we’ll be able to show more mature durability data. The second reason, as I mentioned, is that we want to ensure we can have a proper pre-NDA meeting with the FDA before finalizing our NDA strategy. And we’d like to, again, resolve the clinical hold in order to have time to have a proper pre-NDA meeting; discuss our strategy and then move forward to submitting the NDA.

[Michael Yee:]

I guess, to clarify the first one, on the EZH2, I know that you want to resolve the hold and then re-engage with them. I guess, in terms of confidence of completing the enrollment of the cohort, which I think is certainly important because you need follow up on every one of those patients, the confidence around that happening this year?

[Rob Bazemore:]

Certainly, we’ve not updated the guidance other than to say that we would provide new guidance once we are able to resolve the hold. But I can tell you, Mike, that we have continued to enroll patients who have EZH2 mutations in those countries around the world that are not currently on clinical hold even since we presented the data at EHA.

[Michael Yee:]

Okay, thank you.

[Operator:]

Our next question comes from Robyn Karnauskas with Citi.

[Rob Bazemore:]

Hi, Robyn.

[Robyn Karnauskas:]

Hey, guys. Hi, good morning. So I was just wondering if you – the DLBCL combo trials, I was wondering if you can remind us whether the combo trials are stratified based on the EZH2 status? Or are you focusing on all-comers for these combo trials? Also, is there any preclinical data for these combos to suggest that tazemetostat is likely to work better in patients with mutations even in the combo setting? Thank you.

[Susan Graf:]

Sure, it’s Susan. So with regard to the combos that we have ongoing; the R-CHOP combo is obviously front line patients. It is not prospectively stratified by EZH2 mutation. And yes, we do have preclinical data that suggests there could be some synergy between tazemetostat and components of the R-CHOP regimens. With regard to the atezolizumab combo, that population is a relapsed/refractory DLBCL population. However, it is also not stratified by EZH2 mutations, so with the relapsed/refractory all-comer population. And again, we have some preclinical data that we’ve generated as well as others in the field that talk about how EZH2 inhibition could positively impact the cancer immunity cycle, and therefore, give rise to greater responses to checkpoint inhibitors.

[Robyn Karnauskas:]

Great. Thank you so much.

[Susan Graf:]

You’re welcome.

[Operator:]

[Operator Instructions] Our next question comes from Sheldon Fan with Leerink Partners.

[Susan Graf:]

Good morning.

[Rob Bazemore:]

Good morning.

[Operator:]

Sheldon, your line is open. If your line is muted, could you please unmute the phone line.

[Sheldon Fan:]

Sorry, I was unmute. Hi this is Sheldon on for Geoffrey Porges. We have several questions here. So firstly, could you comment more on the opinions from the expert panel that we have convinced on the risk of T-cell lymphoblastic lymphoma as that lymphoma case – single-lymphoma case seems it related to the treatment or not? And my second question is, you mentioned that you may change the patient population for this investigation. Have you identified any certain patient population that may have higher risk for this lymphoma? And for follicular on – what’s your plan for the registration to be discussed with FDA? Would you proceed with only the EZH2 mutated population or the wild-type or both? And lastly, what’s your plan for mesothelioma? Thanks.

[Rob Bazemore:]

Okay. I think I captured all those, so let me walk through them one by one. First of all, in terms of the evaluation that we’ve done for tazemetostat based on the partial clinical hold, we looked at a number of things. One is we’ve evaluated this case of TLBL in the single pediatric patients, what we can learn from it, but also done a more full assessment of the risk of TLBL in patients who have the various types of tumors that we’re studying. We already knew that this was something that we have talked about in our investigator brochure as well as in our form consent. This was a preclinical tox finding that we had very early on in the program and something that we had already listed as an adverse events of special interest, so it wasn’t something that was new. We presented these data as well as the rest of the findings. We have done a complete assessment of the safety as well as benefits of tazemetostat across the trials that we’re conducting and that was essentially what we’ve discussed with the expert panel to ensure that we had an external objective view on the way – our position and the way we view it. I can tell you they are very supportive, they validated our approach to this. And so we’ve more or less finalized our position now, and in the coming weeks, we’re going to be discussing that and trying to make sure we have alignment with the FDA on it before we submit our complete response. In terms of the changes and what kinds of protocol amendments; we will be looking at the typical types of things, if they’re particular patient populations that would change. We would also look at how we might handle any future secondary malignancies, should they occur. How do we handle those individual patients? How do we handle it overall? The typical kinds of things that you would do as a result of a new clinical case of a TLBL or something like this that you haven’t seen yet in a study. I can tell you that the changes that we would contemplate come from a place though, and our assessment overall continues to support a very favorable benefit/risk profile for tazemetostat across our clinical programs. We’re not prepared to discuss those. We’re just finalizing any recommendations that we would make now, and obviously, we would want to get FDA’s approval on those before we communicate them externally. In terms of our registration path in follicular lymphoma, as I suggested to Mike’s question earlier, we’re very excited about the data we have in both patients who have EZH2 mutations as well as in patients who are wild-type. It’s important to us that we present the totality of these data to the FDA in our discussions around a registration strategy and how we might handle both. We look forward to re-engaging with the FDA. I wouldn’t speculate beyond that at this point, but we look forward to re-engaging with the FDA and talking more about this data package that we have in follicular lymphoma and a path forward to registration as soon as we’re able to resolve the clinical hold. And then finally, the question on mesothelioma, nothing has changed since our last update. We were very encouraged to see that we have clinical activity in mesothelioma. This was noted by the high response rate that we saw, the disease control rate. We announced though that because of the objective response rate, we didn’t see a path forward as a monotherapy, even though the disease control rate was encouraging in this difficult to treat patient population. But we are looking at combination approaches to mesothelioma as the next steps for that program.

[Sheldon Fan:]

Thanks.

[Operator:]

Our next question comes from Peter Lawson with SunTrust Robinson.

[Rob Bazemore:]

Hi, Peter. Good morning.

[Peter Lawson:]

Good morning. Thank you for taking the questions. The delay in the filing, is that mostly down to the clinical hold or do you feel you’re kind of delaying it mostly to get more data?

[Rob Bazemore:]

Peter, it really is both. It’s a tandem thing. I think that the desire to have better durability data is certainly something that we feel will strengthen the package and again we go back to the – in the Phase II discussion that we had had with the FDA last year. We understand that, because there are no drugs approved in this disease, and because the drugs that are used to treat them are typically the broader soft tissue sarcoma drugs, the responses to these drugs are quite modest both in terms of the response rate, but also the durability of the benefit. And so, we think it’s to our benefit, particularly given that this is the first filing for tazemetostat for any indication to have as robust a package as we can of benefit in these patients with epithelioid sarcoma. Durability will be very important to that. So we think it’s important to strengthen the package to have more robust durability data. But, to the second part of the question, for certain, we wouldn’t imagine moving forward in filing our first NDA for tazemetostat without having a proper pre-NDA meeting. And we need to make sure that we have time after resolving the hold to do that and gain alignment with the agency on our strategy for approval.

[Peter Lawson:]

So, would you have delayed that filing if you didn’t have the hold, just kind of curious around the dynamics there about the extra data?

[Rob Bazemore:]

It’s a good question. It’s an important one that I think that we would had given it a serious consideration, it’s likely we would have made the same decision, again, going back to the importance of having a very strong data package in this patient population with epithelioid sarcoma.

[Peter Lawson:]

And then just timing around the combo data, I’m sorry if you’ve highlighted that earlier. I just joined the call late. If you can give me some timing around the combo data and what comes first. I know you’ve got certain degree of control around some of those combos versus others.

[Susan Graf:]

Yes, good morning, Peter. The LYSA data, we anticipate that LYSA will be presenting that at a Medical Congress second half of this year. In terms of the dataset there, it will be the 1b portion, safety, tolerability and PK. And what you’ll be able to see is really what tazemetostat looks like in combination with the R-CHOP regimen there in roughly 20 patients. In terms of the Genentech data, tazemetostat plus atezolizumab, that data we expect Genentech to present some time in 2019.

[Peter Lawson:]

Got you, thank you. And then, I know there has been lot of questions just around the hold. Do you think you’ll – how far away are you from submitting the package back to the FDA?

[Rob Bazemore:]

Peter, we would love to do this as soon as we can. I think, as I’ve mentioned on the call, our work, the assessment that we’ve done to really understand the specific case of TLBL, this patient who had this case in the pediatric study; the risk of TLBL overall; as well as other going through the safety, the efficacy findings from across our clinical program to create a very broad benefit/risk package. That work is essentially done. So we look forward to engaging – in fact, we’re already beginning to engage with the agency to define and align on the adequacy of that. We want to make sure that we incorporate any agency feedback before we put together our complete response so that ultimately we can be successful and this is the best possible approach for the molecule and for patients, to be able to reopen our trials.

[Peter Lawson:]

Thank you. And then just finally, and I apologize, because I was jumping between calls. The INI negative tumors, how should we be thinking about that? Is that really kind of very much deprioritized, do you have a route forward?

[Rob Bazemore:]

No, Peter. In fact, we’ve – those studies have continued to enroll patients. And when we present data later this year, our plan is that we would present data from not only epithelioid sarcoma, but we would be presenting data from the other INI1-negative cohorts as well. We announced on the call, since you weren’t on the call but be able to hear it, that we announced that those data have been accepted for publication or for presentation at ESMO, which is coming up later this year.

[Peter Lawson:]

Perfect. Thank you so much.

[Operator:]

[Operator Instructions] Our next question comes from Laura Christianson with Cowen.

[Laura Christianson:]

Hi, guys. Thanks for taking my questions. Just a couple; one is, you highlighted a couple of reasons on the call for what prompted your decision to not move forward in development in TLBCL. But I’m just wondering if you can give a little more detail on specifically what changed given the initial excitement around that data? Thanks.

[Rob Bazemore:]

Certainly. So we – there were essentially three things. We, when doing the interim analysis, looked at the clinical activity. And while we’re seeing activity in this patient population, DLBCL is a very aggressive disease, as you know. We’re continuing to see objective responses. In fact, some of the patients both in the wild-type and the EZH2 mutational cohorts have complete responses and many of them have very long durability of response. So we’re continuing to see activity. However, we didn’t feel, after looking through the interim analysis that the data that we’re seeing, the activity that we’re seeing is sufficient for registration path as a monotherapy. If you look at most of the treatment regimens that are being used to treat DLBCL today and even the evolving treatment landscape, almost all of them are combination regimens, and we feel that that’s the proper way to move forward with the development of tazemetostat in patients with diffuse large B-cell lymphoma. We did – this is an important decision for us as a company. Obviously, it’s not one that we take lightly. So we took the time to meet with our investigators and other experts to question our thinking on it. Ultimately, we have patients on the trial who are benefiting. So it’s not a decision that we take lightly. But we think it’s the right one. At the end of the day, we are a data-focused organization and we want to put our resources in the places where we think we can create the most value. So we will continue to move the DLBCL program forward, but in a combination approach and not a monotherapy approach.

[Laura Christianson:]

Got it. And then, it sounds like – if I’m understanding you correctly, all the patients who were previously on the tazemetostat trials and were reconsented did agree, again, to continue on the trial. Where there any patients who decided not to?

[Rob Bazemore:]

Our understanding from our investigators is that we’ve had no patients who refused to re-consent and continue on with the trials, which I think is a great testament to our investigators and their belief in the program and their wish to continue developing tazemetostat.

[Laura Christianson:]

Great, thank you.

[Operator:]

I’m not showing any further questions at this time, I’d like to turn the call back over to CEO, Rob Bazemore.

[Rob Bazemore:]

Thank you, Kevin, and thanks to all of you who’ve joined us this morning. We appreciate your support as we advance our agents and explore the right opportunities to bring them to patients. I look forward to speaking with you at upcoming conferences and to seeing you at ESMO for the updated presentation of our ES data. And that concludes our call for today.

[Operator:]

Ladies and gentlemen, this does conclude today’s presentation. You may now disconnect and have a wonderful day.