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Deciphera Pharmaceuticals, Inc. (DCPH 3.09%)
Q4Â 2019 Earnings Call
Mar 9, 2020, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good day everyone, and welcome to the Deciphera Pharmaceuticals Fourth Quarter and Full Year 2019 Financial Results Conference Call. Today's call is being recorded.
At this time, I would like to turn the call over to Jen Robinson, Vice President-Investor Relations. Jen?
Jen Robinson -- Vice President-Investor Relations
Thank you, Michelle. Welcome and thank you for joining us today to discuss the Deciphera fourth quarter and full year 2019 financial results. I'm Jen Robinson, Vice President-Investor Relations at Deciphera. With me this afternoon to discuss the financial results and provide a general corporate update are Steve Hoerter, President and Chief Executive Officer; Matt Sherman, Chief Medical Officer; Dan Martin, Chief Commercial Officer; and Tucker Kelly, Chief Financial Officer.
Before we begin, I would like to remind you that any statements we make on this call that are not historical facts are forward-looking statements, reflecting the current beliefs and expectations of management made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements made during this conference call include the status of, and our expected time lines for, our preclinical and clinical studies, review of our NDA submission and potential commercial launch.
Forward-looking statements made on this call involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we cannot assure you that our expectations will be achieved. Such risks and uncertainties include the execution of clinical trials, the timing of study data, the actions of regulatory agencies and those set forth in our most recent Annual Report on Form 10-K, as well as our other SEC filings. We assume no obligation to update or revise any forward-looking statements. Following this call, a replay will be available on the Company's website, www.deciphera.com.
With that, I will now turn the call over to Steve Hoerter, President and Chief Executive Officer of Deciphera. Steve?
Steven L. Hoerter -- President & Chief Executive Officer
Thank you, Jen. Good afternoon everyone, and thank you for joining us on this call to discuss our fourth quarter and full-year 2019 financial results as well as clinical and business updates. 2019 was a year of exceptional execution by the team here at Deciphera. Most significantly, we reported positive results from our INVICTUS, our pivotal Phase 3 study with ripretinib and patients with advanced GIST whose previous therapies include at least imatinib, sunitinib and regorafenib. These results form to the basis of our first NDA submission, which was recently accepted by the FDA with Priority Review and signed a PDUFA target action date of August 13 this year. The ripretinib NDA is being reviewed under the FDA's Real-Time Oncology Review or RTOR pilot program. The RTOR program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.
In addition, with the ripretinib NDA, we are also participating in the FDA's Project Orbis initiative. Under this program, we have received Priority Review for a new drug submission with Health Canada and a market authorization application with the Therapeutic Goods Administration in Australia for ripretinib in advanced GIST. We plan to submit a marketing authorization application to the European Medicines Agency in the second half of this year.
We're very proud of our execution on the ripretinib program in GIST where we took the compound from IND filing to NDA submission in just over four years. The team designed and executed a clinical and regulatory strategy that allowed us to move rapidly to multiple registration studies, generating compelling data sets that have resulted in our inclusion in a number of regulatory designations and programs from breakthrough therapy designation to the Real-Time Oncology Review pilot program to Project Orbis. And we believe our team can direct these capabilities to the rest of our clinical and preclinical pipeline to continue to generate value beyond ripretinib.
Importantly in 2019, we also made significant progress with our two other wholly owned clinical stage product candidates, DCC-3014 and rebastinib, and we introduced our newest preclinical product candidate, DCC-3116. We remain focused on leveraging our proprietary research platform to build a deep pipeline of novel kinase switch control inhibitors to address unmet medical needs for patients with cancer. Building off the tremendous work done in 2019, we look forward to a transformational year for Deciphera this year. We are well positioned for success as we seek to transition from an R&D organization to a commercial stage company based on the potential launch of our first approved products in the US later this year.
We believe 2020 will be an exciting year for our pipeline with significant milestones expected across our clinical and preclinical programs. As Matt will discuss in more detail, we expect to have important clinical updates with data on additional tenosynovial giant cell tumor patients with DCC-3014, data updates for our rebastinib development program, and an IND filing for DCC-3116, a potential first-in-class ULK inhibitor targeting mutant RAS cancers.
To review these programs in greater detail, I will now turn the call over to Matt Sherman, our Chief Medical Officer. Matt?
Matthew L. Sherman -- Executive Vice President & Chief Medical Officer
Thank you, Steve. As Steve mentioned, we have a robust pipeline of novel kinase switch control inhibitors, all derived from our proprietary discovery research platform well designed to address unmet medical needs and difficult-to-treat cancers. First, I would like to review our progress with ripretinib, our investigational broad spectrum KIT and PDGFR alpha inhibitor. As we work toward the potential approval and launch for ripretinib in patients with advanced GIST whose previous therapies include at least imatinib, sunitinib and regorafenib, we continue to explore other possible uses of our ripretinib, including in second line GIST patients.
INTRIGUE is our ongoing Phase 3 study of ripretinib in patients with second line GIST compared to the current standard-of-care sunitinib. Both site activation and patient enrollment continue to go very well, and we currently have 111 sites activated in 20 countries. As we recently disclosed due to an early trend of a higher-than-expected number of censored patients, we are planning to increase the total number of patients in this study to help achieve the pre-specified number of events in a timely fashion. The anticipated increase does not change the total number of required events, the statistical powering of the study and our current guidance achieving full enrollment in the second half of this year.
We remain confident in the potential for ripretinib to be an important and effective therapy for patients with GIST after treatment with imatinib. Data we presented last fall from the second line GIST cohort in our ongoing Phase 1 study continue to show highly encouraging clinical activity based on a median progression free survival 46 weeks or 10.7 months and the 19% confirmed objective response rate. As you will recall, published data from the centrally read pivotal study for sunitinib show the median PFS of 24.1 weeks or 5.6 months and a confirmed objective response rate of 6.8%. Outside of GIST, we expect to present data from at least one of the expansion cohorts of our ongoing Phase 1 study of ripretinib in the second half of 2020.
Beyond ripretinib, we are focused on rapidly developing DCC-3014, our highly selective inhibitor of CSF1R for patients with tenosynovial giant cell tumor or TGCT. TGCT is a rare disease with an estimated annual incidence of the localized form of 13,000 and approximately 1,300 for the diffuse-type of the disease in the US. Annual incidence rates may not provide the full picture, since these patients typically present relatively early in adults [Phonetic] and can live with the disease for a long time, indicating that the prevalent population may be substantially greater. The only approved systemic therapy for patients TGCT is pexidartinib, a small molecule inhibitor of multiple kinases including CSF1R, which was approved in August of last year and is subject to a REMS program due to hepatotoxicity, which is believed to be off target.
We believe that DCC-3014 has potential to fulfill the unmet medical need for an effective treatment with a more favorable safety profile for patients with TGCT. Last year, we presented preliminary clinical proof-of-concept data in the initial three patients with diffuse-type TGCT at the Connective Tissue Oncology Society Annual Meeting. Encouragingly, all three patients showed preliminary anti-tumor activity as of the first scans. At the first tumor reassessment at cycle three day one, tumor reductions from baseline were 48%, 25% and 24% respectively. At the data cut-off date of September 2019, one patient had a confirmed partial response, which was ongoing for nine months, the tumor reduction from baseline the 84% as of Cycle 10 day one. Symptomatic improvement in mobility and reduced pain as reported by the investigator were also observed. DCC-3014 was generally well tolerated with no grade 3 or higher treatment-emergent adverse events observed in diffuse-type TGCT patients.
In 2020, we expect to select the Phase 2 dose and open a Phase 2 expansion portion of the study in TGCT patients. We are continuing to enroll TGCT patients in the ongoing dose escalation portion of the Phase 1 study and look forward to presenting additional data on these patients in the second half of this year.
Next in the pipeline was rebastinib, our potent and selective TIE2 inhibitor, which we're exploring in two clinical studies in combination with chemotherapy, one with paclitaxel and one with carboplatin. In January, we announced that we have selected the Phase 2 dose of 100 milligrams twice daily of rebastinib in combination with carboplatin and activated Part 2 of the study where we are evaluating combination to patients with breast cancer, ovarian cancer and mesothelioma. Last year, we presented preliminary data from the Phase 1b/2 study of rebastinib in combination with paclitaxel. We saw encouraging preliminary activity with objective responses in patients, but increasingly received treatment with paclitaxel across multiple solid tumor types. We are actively enrolling the expansion cohorts Part 2 of the study in patients with breast, ovarian and endometrial cancer. In the second half of this year, we expect to report data from both of the paclitaxel and carboplatin studies.
Finally, our discovery research engine continues to generate new product candidates from novel targets. And we disclosed last year that the next target we will be pursuing is the ULK kinase for patients with mutant RAS cancers. The ULK kinase is the initiating factor and the autophagy pathway, which is a cellular energy recycling pathway has been shown to be upregulated in mutant RAS cancers and mediates from assistance to inhibitors of a RAS kinase signaling pathway. DCC-3116 is our potential first-in-class ULK kinase inhibitor that we intend to develop for the treatment of mutant RAS cancers. And we're working toward filing the IND for 3116 later this year.
Deciphera is a company founded on deep insights into kinase biology and focused on developing important new medicines for the treatment of cancer. We have demonstrated the ability to discover and develop novel drug candidates based on our proprietary research engine centered on kinase switch control in addition, and I look forward to updating you on the progress with our clinical and preclinical programs throughout the year.
I will now turn the call over to Dan Martin, our Chief Commercial Officer, to discuss our commercial preparations for potential launch of ripretinib in the US. Dan?
Daniel C. Martin -- Chief Commercial Officer
Thank you, Matt. We are tremendously excited about the potential for ripretinib to address critical unmet needs for patients battling advanced GIST. As many of you know, GIST is a rare cancer with significant unmet need for patients who develop resistance to first-line of ripretinib. Current second and third-line treatments confirm modest progression-free survival benefit and no overall survival benefit compared to placebo. Further, there are no currently approved treatment options for the vast majority of patients who progressed on third-line therapy except for the 5% to 6% who harbor a rate PDGFR-alpha exon 18 mutation. Determining the precise number of patients who receive treatment for GIST after progressing on imatinib challenge given that existing therapies are more widely used in non-GIST indications and GIST epidemiological studies have typically focused on patients with newly diagnosed GIST as opposed to those with metastatic disease. Analysis of US claims data has helped to refine our understanding of the patient journey in advanced GIST.
Based on these analysis, we estimate that in the US, there are approximately 2,000 incident patients eligible for second-line treatment. Second line is the patient population that we have always viewed as the primary long-term opportunity for ripretinib in the post-imatinib setting and is the focus of the Phase 3 INTRIGUE study. Beyond second line, we estimate the reduction in the incident treatment eligible population of approximately 20% to 30% in each subsequent line therapy due to participation in clinical trials, treatment discontinuation or death. In addition to these claims analysis, we've conducted extensive market research to better understand what GIST treating physicians are looking for in new therapy and to what extent, they think ripretinib could address those needs. Irrespective of line of therapy, GIST treaters have consistently ranked overall on progression-free survival as well as safety and tolerability as their most valued markers of clinical benefit.
And after reviewing blinded product profiles for ripretinib as well as other therapeutic options, GIST treating physicians conveyed high interest in the ripretinib profile due to the efficacy and safety data from INVICTUS as well as the fact, INVICTUS for the Phase 3 placebo controlled study, which they consider to be the gold standard further enhancing their confidence in the data. Our preparations are on track for our first commercial launch pending FDA approval of ripretinib. Under Matt's leadership, our medical affairs team is in place and our MSLs that are engaging Sarcoma experts in scientific exchange.
On the commercial side, our marketing team has launched a disease education program to raise awareness of the unmet need in GIST and has defined our go-to-market strategies for launch. Our access team has focused on ensuring optimal patient access on approval of ripretinib, including building out our patient assistance program. As you know, these programs are important for any oncology drug, especially in oral oncology drug often as a result of the patient affordability challenges that can arise due to the Medicare Part D benefit design.
Regarding our sales organization, we've identified who top treaters of GIST are and where they practice. We've defined our sales force size and structure. We built an incredibly season sales leadership team, and we've launched our recruiting of sales representatives. We've been extremely pleased with the deep and talented applicant pool, which includes candidates from virtually every leading oncology company in the industry and has composed of individuals with extensive oral oncology launch experience. We're tremendously excited about the commercial team and capabilities we're building and very grateful to have the opportunity pending approval to help bringing ripretinib to patients this year.
I will now turn the call over to Tucker Kelly, our Chief Financial Officer to review the financial results.
Tucker Kelly -- Executive Vice President, Chief Financial Officer & Treasurer
Thanks, Dan. We'll take a minute to discuss a few highlights from our fourth quarter and full-year 2019 financial results. We remain well capitalized to execute of the compelling opportunity we have with potential launch of ripretinib and a strong clinical and research pipeline. We ended 2019 with cash, cash equivalents and marketable securities of approximately $580 million. And in February, we completed a follow-on public offering that raised approximately $188 million in net proceeds. Based on our current plans, we expect that our cash will be sufficient to fund operations and capex into the second half of 2022. In the fourth quarter of 2019, our total operating expenses increased to approximately $70 million from $58 million in the prior quarter based on increased investments to support our potential commercial launch of ripretinib as well as increased clinical development activities across the pipeline. Research and development expenses were approximately $47 million, and selling, general and administrative expenses were approximately $24 million for the fourth quarter of 2019.
We expect our expenses to grow over the coming quarters as we build our commercial organization and expand our clinical development activities. And with that, I'll now turn the call back over to Steve.
Steven L. Hoerter -- President & Chief Executive Officer
Thank you, Tucker. I'd like to take a moment to thank the entire team here at Deciphera for their dedication to our mission of developing important new medicines for the treatment of cancer. We're very proud of the progress we made in 2019 and are excited about the prospects for 2020 as we look to transition into a commercial stage company and aggressively did all of our exciting clinical and research pipeline. With that, Michelle, I would like to open the call for questions. Operator, would like to [Speech Overlap] for questions.
Questions and Answers:
Operator
[Operator Instructions] And your first question comes from the line of Jessica Fye from JPMorgan.
Jessica Fye -- JPMorgan -- Analyst
Hi guys, good afternoon. Thanks for taking my question. With the enrollment completion for INTRIGUE expected in the back half of this year, what's your latest estimate on when we'll see top line data for that trial?
Steven L. Hoerter -- President & Chief Executive Officer
Hi, Jessica. Thanks for the question. So we have not changed our guidance in terms of time to completing enrollment, which is in the second half of this year. And when we reach full enrollment, our intent would then be to disclose what we anticipate as being the timing for a potential readout of the study.
Jessica Fye -- JPMorgan -- Analyst
Okay. Maybe I can get a second one. What will you be watching for when the avapritinib Voyager study reads out. Is it hazard ratio, safety profile, absolute months of improvement over control, what do you must focused on in that data set?
Steven L. Hoerter -- President & Chief Executive Officer
Yes, good question, Jess. I mean, we're interested really in the totality of the data, based on our understanding of the Company in terms on reporting top line data. So depending on what level of detail they get into, we will be interested in the total view of the data, the risk benefit profile and the like and how that compares with the current label for avapritinib. So we look forward to seeing the data here in the coming quarter.
Jessica Fye -- JPMorgan -- Analyst
Great, thank you.
Operator
[Operator Instructions] And your next question comes from the line of Chris Raymond from Piper Sandler.
Chris Raymond -- Piper Sandler -- Analyst
Thanks guys. Just -- question I guess on INTRIGUE. I know you had a disclosure about the censoring rate being a little higher than expected in the upside. You talked about this in your prepared comments, but I guess I'm wondering if you can give a little bit more sort of color or indication of your communication cadence going forward. So when you actually do decide to upsize it, will you announce that and should we expect to see that perhaps on clintrials.gov [Phonetic] or would you sort of announce that in some other fashion, if you will, and I'm just kind of curious as to how you intend to communicate any sort of changes that actually get enacted going forward?
Steven L. Hoerter -- President & Chief Executive Officer
Yes. Thanks, Chris. Thanks for the question. I mean, first let me just say that our confidence in INTRIGUE remains unchanged. So when we make the final decision on number of patients that will be adding to the study will make a disclosure on that probably both on clinicaltrials.gov as well as updating our investor deck just to make sure that the information is out there. And then as I mentioned earlier, once we reach full enrollment, and our guidance remains the same for the second half, I will then provide at that time some additional guidance on when we expect the study to report out.
Chris Raymond -- Piper Sandler -- Analyst
Great. Okay. And then may be, I'm not sure if you want to [Phonetic] to answer this, but just talking about your launch preparedness, you got a couple of different scenarios I think that you'll be launching ripretinib into you either have a competitor with just label for PDGFR alpha exon 18 patients or one with a broader fourth line label. I guess the question is how different, I would imagine you're planning for both scenarios, but how different are those plans?
Steven L. Hoerter -- President & Chief Executive Officer
Yes, thanks Chris. Good question. Let me make a few comments on that, then I'll flip it over to Dan advance to add some more color. As we think about the profile of ripretinib, we view that the data that we have to support the product, the basis for the NDA as supporting the drug is being bus and class in this setting to treat this disease. It's not common that you see a drug in a pivotal study, a randomized study generate hazard ratio of 0.15. In our case, the acid ratio for PFS is 0.15, or the overall survival for that matter 0.36. So this is, I think signal isn't very compelling, our profile in terms of efficacy and then we know from the tolerability profile of the drug that the drug is generally well-tolerated and INVICTUS was very consistent with the broad Phase 1 set of data that we've already published.
So we have a high degree of confidence in terms of how physicians will view those data. Dan, I think mentioned in his prepared remarks some of the research that we've done with physicians with potential prescribers and Dan maybe he will add some additional color.
Daniel C. Martin -- Chief Commercial Officer
Yes. Thanks, Steve, and Chris, good question. So of course it's great to have more options for patients. But when we think about how the treatment paradigm may shape up in the days to come, we really focus on what our market research has helped to educate us about, which is what just treating physicians say they're really looking for and I mentioned in my prepared remarks, but it's these endpoints progression-free survival and really unique in the space overall survival relative to placebo, as Steve mentioned in addition a clean, safety and tolerability profile. That's what they tell us we're looking for and when we did the research to show blinded profiles across ripretinib as well as other treatment options in the space, what came back really consistently was their interest level and a product like ripretinib.
In fact, in one study, we did about 97% of the respondents said they'd be interested in a product with ripretinib's profile for treatment of patients and just [Phonetic]. So we really are focused on how we can best get ripretinib to patients as quickly as possible, because we think it can have a real positive impact as they battle their disease.
Chris Raymond -- Piper Sandler -- Analyst
Great, thanks a lot.
Operator
[Operator Instructions] And your next question comes from the line of Eun Yang from Jefferies.
Eun Yang -- Jefferies -- Analyst
Thank you. So, for second-line GIST, so when you look at Phase 1 study, you've shown more than 20 weeks of PFS improvement compared to what sunitinib has shown in Phase 3. But in the clinic, based on your conversation with oncologist, what would be the kind of a minimum PFS benefit that they would have consider clinically meaningful compared to sunitinib?
Steven L. Hoerter -- President & Chief Executive Officer
Yes. Hey, Eun. Thanks for the question. So you're right. In that second-line cohort from the Phase 1, what those data have shown based on our recent update from the end of last year is a 10.7-month progression-free survival for that cohort. Of course, that's a non-randomized setting. But if you do the cost setting comparison that you just mentioned and look at the Sutent label, that does represent a really substantial difference relative to what Sutent offers. And I think Matt commented on this in his prepared remarks. So in the context of -- on INTRIGUE, we think that a clinically meaningful difference in progression-free survival would be in the range of two months to three months.
I mean, we think certainly based on the data that we've generated in the Phase 1 study so far, we have a lot of optimism in terms of how we view the potential for ripretinib that offer benefits patients in that setting.
Eun Yang -- Jefferies -- Analyst
Okay, thanks. And then one question on 3014, CSF1R inhibitor. So when you move into registration trial, do you think you need to compared to pexidartinib in order to recruit patients faster?
Steven L. Hoerter -- President & Chief Executive Officer
Yes, thanks Eun for the question. So it's not clear to us yet whether what the design for that pivotal study would be and as we said, we will provide some additional guidance on that toward the end of this year as we've provided data update from the Phase 1. I think there are potentially a variety of different options. One can be a placebo-controlled study and other could be a head-to-head study, but we of course need to generate some more data, have some discussions with the regulators and then determine what our pivotal study strategy is going to be. As I said, we'll have some additional information on that we think at the end of this year.
Eun Yang -- Jefferies -- Analyst
Thank you.
Steven L. Hoerter -- President & Chief Executive Officer
Thank you.
Operator
And your next question comes from the line of Michael Schmidt from Guggenheim.
Michael Schmidt -- Guggenheim -- Analyst
Hey guys, thanks for taking my questions. I just wanted to follow up on the INTRIGUE trial disclosure. We've gotten a fair amount of questions on sort of maybe you could help from a stand against of what's been driving the higher-than-expected rate of discontinuations I suppose and what your confidence level is that there is now imbalance and those dropouts in either of the arms.
Steven L. Hoerter -- President & Chief Executive Officer
Yeah. Thanks, Michael. It's Steve. Thanks for the question. As I alluded earlier, our confidence in INTRIGUE is unchanged. I noted that our guidance remains the same in terms of enrollment. And I think it's also important to remember that there has been no change in the number of events required iteration of study or the powering of the study. So this is really about enabling a readout in a timely fashion for the study.
In terms of censoring seen in the study, this is a phenomenon of any event-driven study on oncology, where you see censoring. So it's not something that's surprising that us that we see this dynamic and we have confidence that by adding a number of subjects to the study that we can ensure timely readout for INTRIGUE. So we look forward to of course generating data. And as I noted when we reached full enrollment, we will then provide some additional disclosure on the potential time to readout for the study.
Michael Schmidt -- Guggenheim -- Analyst
Okay. Great. Thanks. And then regarding the update from the Phase 1 study of ripretinib in other cancer types that you guided to in the second half of this year, I guess should we think about this predominantly as an update from the systemic mastocytosis arm or potentially from some of the other cohorts that you've been enrolling? And I guess what type of data would you like to see that in order to justify potential further next steps and additional trials in any of these indications?
Steven L. Hoerter -- President & Chief Executive Officer
Yeah. Thanks, Michael. So, as you know, we have a number of expansion cohorts in the ongoing Phase 1, including the cohort in mastocytosis. We have a cohort in KIT-driven melanoma. We have a GBM cohort. So a number of cohorts where we're investigating the potential for ripretinib to play a role in other tumor types. So, as you noted, our guidance is to provide an update from at least one of those cohorts within a year. And our hope is that mastocytosis could be one of those cohorts and potentially a lot of further data as well. And this is of course depending upon getting patients enrolled and generating data. So it's really premature for me to comment on what the bar would be in any of these cohorts that warrant further study. I think we need to see the data mature, understand the data, of course present the data and then at that time, I think we'd be in a position to offer some additional color on where we might go from there.
Michael Schmidt -- Guggenheim -- Analyst
Understood. And then you did provide some updated information on the identified or treated patient population in GIST in the US. how should we think about the potential market opportunity ex-US and maybe more specifically in Europe for GIST?
Steven L. Hoerter -- President & Chief Executive Officer
Yes. let me -- good question, Michael. Let me start off with the answer to that and then let me ask Dan to offer some additional color if he has any. So in this disease, we didn't expect the incident population of GIST is any different in the US versus any other geography around the world. So I think the best way to generate an estimate for GIST in Europe is really to look at it on a population basis relative to the US. And so, based on that, we would expect to see not only larger number of patients in Europe relative to the US just based on population differences. Dan, I don't know if you have any additional color you would offer on that.
Daniel C. Martin -- Chief Commercial Officer
Yeah, sure. Just a little bit. Thanks, Steve. So when you extend the incident rate that Steve was mentioning to our European and Japanese population, whereas in the US, we think there is probably 4,000 to 6,000 incident patients with GIST, newly diagnosed GIST as per The American Cancer Society. We think in Europe and Japan together, that would bring you to approximately 8,000 new patients -- incident new patients in those parts of the world.
Michael Schmidt -- Guggenheim -- Analyst
And then when we think about the second through fourth line, would that be a similar I guess haircut, so to speak to get to those numbers ex-US?
Steven L. Hoerter -- President & Chief Executive Officer
We haven't done any primary research in those territories yet, Michael, to provide further guidance, but we would assume that it would be substantially similar in terms of what you see in the treatment paradigm as patients [Indecipherable] a lot of therapy and then progress and need to receive treatment with the next one.
Michael Schmidt -- Guggenheim -- Analyst
Okay, great. Thanks for clarifying.
Steven L. Hoerter -- President & Chief Executive Officer
You bet.
Operator
And your next question comes from the line of Robyn Karnauskas from SunTrust.
Robyn Karnauskas -- SunTrust Robinson Humphrey -- Analyst
Hi guys. Thanks for taking my question. Just a couple of follow-ups. Maybe first on the NCCN guidelines, ripretinib got on there pretty quickly. Maybe give your thoughts on any hurdles you think about getting on the guidelines that you're -- once you approve. And then second, how is your early access program going? And then third, I know you feel like you're not surprised that these -- that you may have to upsize the trial because of the censoring that you're seeing, but why want those assumptions included in your original protocol? Help us understand like maybe some differences between your original assumptions and maybe what you were seeing in the blinded data. Thank you.
Steven L. Hoerter -- President & Chief Executive Officer
Hey, Robyn. It's Steve. Thanks for the tripartite question. Let me try and knock these off one by one. So in terms of the NCCN guidelines, we think it's very encouraging that the NCCN chose to act so quickly to update the treatment guidelines in the compendium post the approval of avapritinib. And I think that is reflected in part of the unmet need generally speaking in GIST and how physicians are excited about the potential for new treatment options for their patients given that unmet need. So our expectation would be that the panel moves quickly upon a potential approval of ripretinib in the US to evaluate our data and then make a determination of how to reflect that in the NCCN guidelines.
So, I think the second part of your question I think was related to the Expanded Access Program that we launched. And maybe I can provide just a brief update on the EAP. So we're very pleased with the pace of sites opening and patients enrolling on the EAP. I can offer that we've seen patients enroll in a variety of different jurisdictions in the US, in Europe and in a variety of different other geographies beyond the US, in Europe, and again, our view of the number of subjects that we now have on the EAP is that this is again just reflective of the general unmet medical need in this population. So we're pleased to see the patients have the ability to access ripretinib in that context.
So then I think the third part Robyn had to do with INTRIGUE and I think your question was, why is it that we find ourselves adding subjects to study. And I think there's kind of an easy way to think about this. Generally, with the event-driven studies in oncology as I noted, you have this phenomenon where patients are censors. So when you set out, when you initiate a study, I think certain set of assumptions in terms of how many subjects might be censored and therefore, what should your overall NB in the population. And this is -- it's probably not entirely common that the company has come to this realization in the course of the study conduct early enough to be able to actually add subjects to the study.
Oftentimes, we will see companies do is simply announce that there is a delay in the report out of the study as they're waiting for the number of events to accumulate. So in our case, we made a certain assumption when the study -- when the protocol was written. It turns out based on some early indications from INTRIGUE with that. That set of assumptions may have been a little bit off of the mark. And so, that's the reason we've taken this approach to just ensure we get to the requisite number of events in a timely fashion.
Robyn Karnauskas -- SunTrust Robinson Humphrey -- Analyst
Okay. Thank you.
Operator
Thank you. And your next question comes from the line of Ren Benjamin from JMP Securities.
Reni Benjamin -- JMP Securities -- Analyst
Hey, good afternoon guys. Thanks for taking the questions. Could you talk a little bit about how many patients might be added to the INTRIGUE study. Are we talking about handful tens, hundreds and maybe what is the gating factor that remains before you implement such a change and kind of how long does it take once you've decided on the change to actually get the trial sites to implement this?
Steven L. Hoerter -- President & Chief Executive Officer
Yeah, Ren, thanks for the question. So we haven't yet disclosed that number as we're still working through the amendment. And as you probably know, there is a process one has to go through to get the amendment written to get it reviewed appropriately to get it out to sites. And so, as soon as we're on the back end of that process, we will then update our disclosures as I mentioned earlier.
Reni Benjamin -- JMP Securities -- Analyst
Okay. And then one of the things that we noticed, at least with the Orbis initiative is I guess a couple of additional countries have come on board. If we were at Singapore and potentially Switzerland, it is the application with ripretinib kind of automatically get filed to those countries or is that something that you need to apply for separately?
Daniel C. Martin -- Chief Commercial Officer
Yes. I think that's right. So FDA's intent, at least based on that we've seen, based on interviews that have been given by Dr. Pazdur, FDA's intent, I think, is to try to broaden this program over time. I think I maybe read the same article that you did about Singapore and Switzerland potentially being included in future. But in our case, the two countries that are within scope are the ones that I mentioned, so Canada and Australia, where we've now received priority review. And so we don't have any expectation that the number of countries is going to increase from those two. So you can expect it would be just Canada and Australia that would be part of this project. One is for the ripretinib application.
Reni Benjamin -- JMP Securities -- Analyst
Got it. And then just one final question is, have you already had discussions with the EMA as you are preparing for following the second half or are you waiting on anything in particular before having the discussions?
Daniel C. Martin -- Chief Commercial Officer
Yes, we're working toward, as I noted, a filing in the second half of the year. And so we haven't talked about specific interactions with those specific regulators, we're just working toward getting that filing in and that will be the next disclosure that you see from us related to the MAA, the disclosure related to the filing in the second half.
Reni Benjamin -- JMP Securities -- Analyst
Great, thanks for taking the questions.
Daniel C. Martin -- Chief Commercial Officer
You bet. Thanks, Reni.
Operator
And your next question comes from the line of Peter Lawson from Barclays.
Peter Lawson -- Barclays -- Analyst
Hi, Steve. Just wondering if you could -- do you have a good handle, as we think about INTRIGUE, do you have a good handle on censoring events or is that still kind of playing out. Is that still evolving?
Steven L. Hoerter -- President & Chief Executive Officer
Yes, thanks Peter for the question. I mean -- we have a very good sense of what we see in the early data. And that was the reason that we took the decision that we do have to add a number of patients to the study. But we don't have any expectation of that trend is going to change over time. No, it's still early. So I suppose that with the addition of more subjects that we might see fewer censoring events and difficult to predict, but it's not anything that's concerning to us. We have a pretty straightforward remedy for this and that is to add a number of subjects to the study. So we're working on that.
Peter Lawson -- Barclays -- Analyst
Will there be any changes to the enrollment criteria for those new subjects so that stays the same looked in?
Steven L. Hoerter -- President & Chief Executive Officer
I'd say it's absolutely the same. So there aren't any other changes to the study. This is just about enrolling subjects to get to the requisite number of events in a timely fashion, no other changes to study.
Peter Lawson -- Barclays -- Analyst
Thank you. And just on, how should we think about pricing discounting any expectations around net -- just metrics we should be thinking about?
Steven L. Hoerter -- President & Chief Executive Officer
Yes, so maybe I can make a couple of remarks and then I'll turn it over to Dan just to comment on that. So as we, as we look at the pricing landscape of course we're now talking to payers right now, sharing with them the product profile for ripretinib trying understanding of how they view value, certainly we're doing the same with physicians and sharing blinded product profile with them and understanding how they view the data and that will eventually guide a pricing decision for us. And Dan, I don't know if you want to offer anymore color there?
Daniel C. Martin -- Chief Commercial Officer
Sure. Yes. Couple of points. Peter thank you for the question. So, from a research perspective, we -- I have of course been engaged with payers to understand their view of just and the unmet need. And we've been really pleased to see in the research that payers actually really do appreciate the degree of unmet need in GIST. You don't always see that in this kind of research and so we're really encouraged to see that. They also, when responding to these blinded product profiles, really, so you can have a positive view of the ripretinib profile and what that could mean for patients. So we're confident that payers ultimately will appreciate the value that ripretinib can bring to their patients. And beyond that, it's premature for us to comment on price. As it relates, you mentioned discounts, while we wouldn't comment on gross to net per se, one thing that we have tried to underscore is the importance of patient assistance programs, these free drug programs in this space, any oral oncology drug. These programs are important just given the patient affordability challenges that can arise as a result of the Medicare Part D benefit design. So that's something that you want to keep in mind as you're thinking about your models.
Peter Lawson -- Barclays -- Analyst
Great, thank you so much.
Operator
And your next question comes from the line of Christopher Marai from Nomura.
Christopher Marai -- Nomura -- Analyst
Hi, good afternoon. Thanks for taking the questions. First, just with respect to ripretinib and future potential studies. Maybe elaborate on when you might start or if you're thinking is starting earlier line setting trials, in particular some physician checks suggested combinations within that might be interesting to try. I was curious if you've initiated or when you might initiate some trials in that regard and then I have a follow up. Thank you.
Daniel C. Martin -- Chief Commercial Officer
Yes, sure, Chris. Thanks for the question. Steve, I'll take that one. So yes, we're certainly thinking through other places in GIST for example where we think ripretinib might be able to offer benefit to patients. And I think you named some of the possibility, certainly there is a lot of investigator enthusiasm for the INVICTUS data, and for the potential for ripretinib in this disease and that could include combinations with other therapies and certainly the tolerability profile for ripretinib based on the INVICTUS data suggests that the drug might be a good combination partner. And I think there are other settings in the disease where we could generate meaningful data and potentially demonstrate that the drug can offer benefit to patients. So, we intend to actively pursue those now that we have the INVICTUS data behind us and determine next steps and just specifically.
Christopher Marai -- Nomura -- Analyst
When might we hear from you on the initiation of the studies and when might they initiate?
Daniel C. Martin -- Chief Commercial Officer
So we haven't -- I don't have specific guidance for you Chris on that. It's a little early for us to talk about planning for any additional studies. So, at the right time, we'll certainly provide an update on our thinking there and on potential study initiation.
Christopher Marai -- Nomura -- Analyst
Will it be contention upon the second-line data in your mind or in terms of setting up those studies and starting them?
Daniel C. Martin -- Chief Commercial Officer
Yes. I think from our point of view, based on the strength of the INVICTUS data, it's very clear that we have a very active drug in this disease. So I wouldn't see any need for us to wait for any additional clinical data to accrue to guide us to look at other strategies with ripretinib and GIST. But as you know, in addition to INVICTUS of course we have the 178 patient experience from the Phase 1. So, we've generated a lot of data with ripretinib and GIST and I think we have the basis of information that we need to consider additional clinical steps in the disease.
Christopher Marai -- Nomura -- Analyst
Okay. And if we could just shift to 3014 for a second. You guided to providing some Phase 2 dose selection updates and some data updates in the second half of the year. How many patients with the data might we see there. And then secondarily it occurred to me that this trial has -- it looks like, running since 2017, early 2017, so I was just wondering, what's been the delay in accruing patient data here and correct me if I'm wrong about the study start time. But -- anyway, details on both of those would be great.
Daniel C. Martin -- Chief Commercial Officer
Yes, thanks Chris. Thanks for the question. So we reported for the first time the Phase 1 at the Triple Meeting. And this wasn't a solid tumor patient population. So as you might recall, it wasn't until I think early last year the company disclosed a move into tenosynovial giant cell tumor. And so the way to think about it is, we made that declaration of that disclosure in early last year, then started to get sites open that had these patients to enroll and that was -- the result of that it was the data we presented in the initial three patients at the Connective Tissue Oncology Society conference in Tokyo in November, the one that Matt referenced in his prepared remarks.
So that's been kind of the history on the study, so we're actively opening additional sites frankly. We have over time opened additional sites focusing on tenosynovial giant cell tumor, actively enrolling subjects with TGCT in the Phase 1. And while I can't provide guidance now specifically to a number of patients that we might report on in the second half, we expect to have a number of additional patients enrolled on the study from the additional sites that we've opened. So we think we'll have a good number of patients. And again, as Matt mentioned in his prepared remarks, the intent here is to get to a recommended Phase 2 dose, open an expansion cohort, and then based on the data, make a determination about next clinical steps for the drug in TGCT. This is again a disease that, we know, is driven by genetic translocation that results in over-production of the ligand for the receptors of the biology. We think it's very straightforward. And we also know that 3014 is a highly selective inhibitor for this target. So we think it's very well suited for us to move relatively briskly with 3014 in this disease to a potential future registration.
Christopher Marai -- Nomura -- Analyst
Great, that's helpful. And then I guess just to follow up on some of the clarity you provided, the data you'll share in the second half will be sufficient in your minds to progress into pivotal trials just yet. So I assume, you said, it'll be opening the expansion cohorts. We'll need to see some data from the expansion cohorts. How much longer might we have to wait for that data? And then with that data be comparable in your mind to some data we have for pexidartinib currently, to help you make your decisions. Is -- and is that the right way to think about it? Thank you.
Steven L. Hoerter -- President & Chief Executive Officer
Yeah, thanks, Chris. That's exactly the right question to ask I think. And it's just premature for me to comment at this time on when we might be ready, because it depends on data and as data comes in and data matures, and that will then determine when we're ready to launch into a potential pivotal study with 3014 in this disease. So just difficult for me to forecast that from where we are today.
Christopher Marai -- Nomura -- Analyst
Okay. Thank you.
Steven L. Hoerter -- President & Chief Executive Officer
Thank you, Chris.
Operator
Your next question comes from the line of Andrew Berens.
Andrew Berens -- SVB Leerink -- Analyst
Hi, thanks. Congrats on all the progress, guys. A couple of questions on where we might see some data presented assuming that there are going to be any medical conferences in the near future. Are we still planning, and you may have said this in the prepared comments, but I missed that, are we still planning to see the systemic mastocytosis data this year? And I do have a follow-up on INVICTUS too.
Steven L. Hoerter -- President & Chief Executive Officer
Yeah, sure, Andy. Thanks for the question. It's Steve. So yes, what we've said and guided to since the beginning of the year is that we would expect to have data from one or more expansion cohorts from the Phase 1, with ripretinib and that would include systemic mastocytosis. So our hope, of course, is that there are medical conferences, during the course of the year and that would enable us to speak with experts and of course, get data published. So that's our focus.
Andrew Berens -- SVB Leerink -- Analyst
Okay. Thanks. And then in regards to INVICTUS, it's my recollection, there was an extension phase where patients that progressed, I believe on either arm, were able to remain on to enter the extension phase, again double the dose of ripretinib. I don't believe we've seen those data presented anywhere. So, when are we going to see the patients that have more than the normal, the 150 QD? And then also how should we think about those patients potentially on the label?
Steven L. Hoerter -- President & Chief Executive Officer
Yeah, good question. So you're right. In the INVICTUS study, patients who started off on the ripretinib arm upon central PD had the opportunity to dose escalate to 150 BID. And then actually similarly in the in the Phase 1 study, patients in the Phase 1 also had the opportunity to dose escalate to 150 BID. So that's an analysis that that we intend on publishing. I can't guide you specifically, when we might have that analysis ready for publication, but it certainly is we think going to be an interesting set of data. So that's something that the team is working on in terms of analysis and publication plan for those data.
Andrew Berens -- SVB Leerink -- Analyst
Okay.
Steven L. Hoerter -- President & Chief Executive Officer
Second part -- sorry, Andrew, what's the second part to that question?
Andrew Berens -- SVB Leerink -- Analyst
Yeah, it is --
Steven L. Hoerter -- President & Chief Executive Officer
Yeah, on the label. I think was the other part.
Andrew Berens -- SVB Leerink -- Analyst
Yeah. Would those appear on the label potentially?
Steven L. Hoerter -- President & Chief Executive Officer
Yeah, it's not -- it's too early for me to comment on that. Of course, as you know, the FDA is going to be the decision maker in terms of what appears in the label. I think a base case assumption would be that it's going to be based on the 150 QD dose, but we'll have to see how that discussion goes, and what's the final label ends up looking like with the potential approval.
Andrew Berens -- SVB Leerink -- Analyst
Okay, thanks a lot. Appreciate it.
Steven L. Hoerter -- President & Chief Executive Officer
You bet. Thanks, Andy.
Operator
And your last question comes from the line of Arlinda Lee from Canaccord.
Arlinda Lee -- Canaccord -- Analyst
Hi, guys, thanks for taking my questions. I just wanted to clarify on the Phase 1 update for ripretinib. Is that data only going to be for non-GIST indications? Or might we see any additional GIST data there? And is that data going to be sufficient to decide on a go-to expansion phase?
Steven L. Hoerter -- President & Chief Executive Officer
Yeah, hi, Arlinda, it's Steve. Thanks for the question. So that's right. So what we've guided to is that we'll have some data from at least one of the expansion cohorts during the course of this year, in the second half of the year. And so it's too early for me to comment on where those data may or may not lead us. So we have to look at the totality of the data. And once those data are matured and we present them in the second half, and I think at that time, at the time of data presentation, we'd be in a position to then provide some additional color on where we might go with that.
Arlinda Lee -- Canaccord -- Analyst
And then similarly for the scope of the CSF1R inhibitor data at year end, is that going to be sufficient to on mix -- help decide on an expansion? Thanks.
Steven L. Hoerter -- President & Chief Executive Officer
Yeah. So, Chris, I think, had the same question, a couple of minutes ago, and it will depend on the totality of the data that we have. So I think it's premature for us to comment on what we might have at year end and whether that's going to be sufficient for us to decide on the next clinical step. I can just offer that Matt and his team broadly, whether it'd be the clinical operations team or the development team, are very actively working on the balance of our clinical stage portfolio, getting the requisite sites open, getting patients put on study. So we're looking forward to having additional data, more mature data in the second half that we can share with investors and with the clinical community to guide next potential steps with each of these programs.
Arlinda Lee -- Canaccord -- Analyst
Okay. Thank you.
Operator
And this does conclude the Q&A portion. I would now like to hand the call back over to Steve Hoerter.
Steven L. Hoerter -- President & Chief Executive Officer
Yeah. Thanks everyone for joining us on the call this afternoon, and thanks for your continued interest and support of us here at Deciphera. I wish you all a wonderful evening. Thank you very much.
Operator
[Operator Closing Remarks]
Duration: 56 minutes
Call participants:
Jen Robinson -- Vice President-Investor Relations
Steven L. Hoerter -- President & Chief Executive Officer
Matthew L. Sherman -- Executive Vice President & Chief Medical Officer
Daniel C. Martin -- Chief Commercial Officer
Tucker Kelly -- Executive Vice President, Chief Financial Officer & Treasurer
Jessica Fye -- JPMorgan -- Analyst
Chris Raymond -- Piper Sandler -- Analyst
Eun Yang -- Jefferies -- Analyst
Michael Schmidt -- Guggenheim -- Analyst
Robyn Karnauskas -- SunTrust Robinson Humphrey -- Analyst
Reni Benjamin -- JMP Securities -- Analyst
Peter Lawson -- Barclays -- Analyst
Christopher Marai -- Nomura -- Analyst
Andrew Berens -- SVB Leerink -- Analyst
Arlinda Lee -- Canaccord -- Analyst
