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Turning Point Therapeutics Inc (TPTX)
Q1Â 2020 Earnings Call
May 12, 2020, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Ladies and gentlemen, thank you for standing by and welcome to the Turning Point Therapeutics First Quarter 2020 Conference Call.
[Operator Instructions]
I would now like to hand the conference to your speaker today, Jim Mazzola. Please go ahead, sir.
Jim Mazzola -- Senior Vice President, Communication And Investor Relations
Good afternoon, everyone. Following market close today, we filed our Form 10-Q and issued a news release with a summary of our results for the first quarter of 2020. We also updated our investor presentation. You may find these documents posted on the Investor pages at tptherapeutics.com.
Leading the call today will be Turning Point's President and Chief Executive Officer, Dr. Athena Countouriotis, who will provide an overview and update on our business results including our response to the COVID-19 pandemic. Athena's remarks will be followed by a review of our financials by our CFO, Yi Larson. We will take questions following our prepared remarks.
As a company, we are adhering to guidelines with social distancing and remote work. And therefore, the three of us are in different locations today. We have previously recorded our prepared remarks, after which we will host a live Q&A session. So, please bear with us, if this modified approach results in any technical issues.
Before Athena begins, I want to remind you that during this conference call, we will be making forward-looking statements. The company's actual results may differ materially from those expressed in or indicated by such forward-looking statements. For a description of risk factors associated with investing in Turning Point Therapeutics, please refer to our recent filings with the Securities and Exchange Commission.
Now, let me turn the call over to Athena.
Athena M. Countouriotis -- President and Chief Executive Officer
Thank you, Jim, and good afternoon to everyone joining us today.
Before I begin, I want to acknowledge how incredibly challenging this past quarter was for so many in our society and especially thank each and everyone of the dedicated healthcare providers, who have made so many sacrifices these past few months for the health and well-being of patients worldwide. Despite the challenges, we have remained focused on our goals to bring meaningful therapies to patients in need, while navigating the rapidly evolving situation with COVID-19. I am incredibly proud of the progress our team made during the quarter and pleased to now provide an update on the quarter and our response to the pandemic.
For anyone new to our story, at Turning Point, we have internally discovered and developed our wholly owned pipeline of next-generation tyrosine kinase inhibitors that target numerous genetic drivers of cancer. Today, we have four active development programs with the potential to address up to 15% of the targeted therapy opportunity in advanced non-small cell lung cancer, if each of our drug candidates are utilized as single agents.
Starting with repotrectinib and specifically the TRIDENT-1 Phase 2 study. In the first quarter, we remained pleased with the rate of global site activations with approximately 50% of our sites now activated across 11 countries. This includes the majority of our U.S. sites and key sites in Europe and the Asia Pacific region. The Phase 2 portion of TRIDENT-1 is expected to enroll approximately 320 patients. Now, it's up to 120 sites globally. In addition, we continued to anticipate providing early interim data from initial patients in some of the registration cohorts during the second half of the year. I will provide additional detail for that update as I walk through our upcoming milestones.
We also recently completed our first independent Data Monitoring Committee meeting for the TRIDENT-1 study. The DMC is responsible for the oversight of the overall trial conduct and safety profile of repotrectinib within the Phase 2 portion of the study. Their recommendation, based on the initial safety evaluation, was for the study to continue. While it is not our standard practice to give periodic updates on enrollment in our ongoing registration trial, I remained pleased with the progress we made during a very challenging first quarter.
We took multiple steps to help mitigate the impact of the pandemic, which included remote site activation and data monitoring, enabling patients to have routine tests conducted closer to home, and allowing site to evaluate certain patients remotely by phone or video conference. These measures were implemented in collaboration with our CROs, our sites and their IRBs. In addition, we have also evaluated additional sites for participation in our Phase 2 TRIDENT-1 study. Importantly, we have not experienced any COVID-19-related supply interruptions to our clinical programs.
Despite the steps to mitigate the impact of COVID-19, we have more recently started to experience delays in trial site initiations and patient enrollments within the TRIDENT-1 study. We are also closely watching the progress in our other studies and believe the extent of the impact on our pipeline will depend on the continued duration and severity of the pandemic.
Turning to our three earlier stage studies. First, we have an ongoing Phase 1/2 open label study to assess repotrectinib in pediatric patients with ALK-, NTRK- or ROS1-positive advanced solid tumors. We continued to advance that study with site activations and patient enrollment.
Next is our Phase 1 open label study of TPX-0022, our MET/CSF1R and SRC inhibitor, in patients with advanced solid tumors harboring genetic alterations in MET. As a reminder, the study is a standard dose escalation design to determine the maximum tolerated dose, overall safety profile and preliminary efficacy of TPX-0022. The study has enrolled both, TKI naive and pre-treated patients, with primarily exon 14 alterations or MET amplifications. And we anticipate reporting early interim data from initial patients in the second half of 2020. To help guide expectations, we anticipate this update will be primarily a safety update as well as any early efficacy signals as we continue through our dose escalation cohorts.
Next in our pipeline is TPX-0046, our RET/SRC inhibitor. We are encouraged by the potential for TPX-0046, based on its preclinical potency against wildtype KIF5BRET and solvent front mutations including G810R and S. For reference, recent data published in the Journal of Thoracic Oncology, in a total of 11 RET-positive patients treated with the RET inhibitor, selpercatinib, indicated the rate of solvent front mutations was approximately 45% or five of 11 patients. While preliminary, these data are consistent with the prevalence of solvent front mutations observed in other oncogenic drivers, including ROS1, TRK and ALK. The dose escalation portion of our ongoing Phase 1/2 study of TPX-0046 is progressing with enrollment including both TKI naive and pre-treated patients and patients with solvent front mutations previously treated with other investigational RET inhibitors. The study is designed to enroll patients with RET-altered non-small cell lung, thyroid and other advanced cancers.
Lastly, in our pipeline is TPX-0131, our next-generation ALK inhibitor candidate. We announced in January its nomination to enter IND enabling studies with the goal of submitting an IND by early 2021. TPX-0131 has been designed with a compact macrocyclic structure and in pre-clinical studies has been shown to potently inhibit wildtype ALK and numerous ALK mutations, in particular the clinically observed G1202R solvent front mutation and G1202R/L1196M compound mutation. We are excited to advance this drug candidate as quickly as possible and have remained on track with preclinical activities during the pandemic.
From our programs, we have milestones anticipated during 2020 and I will now provide an update of our progress toward each. First, as a reminder, we have guided to providing early interim data from initial patients in some of the registration cohorts of the TRIDENT-1 Phase 2 study during the second half of the year. We are currently monitoring the overall study conduct and data collection to be in a position to potentially provide this update in the third quarter. At this time, we anticipate sharing preliminary efficacy and safety data as it relates to overall responses likely by physician assessment in approximately 30 patients to 40 patients across multiple Phase 2 cohorts, including our registrational and exploratory cohorts. This will allow us to potentially evaluate a data set at our Phase 2 dose in our global Phase 2 study, that is comparable in size to our Phase 1, ROS1-positive efficacy-evaluable population. We are monitoring this very closely, and our goal, given the uncertainty of medical conferences, would be to provide this update with a news release and subsequent call.
As I said earlier, for the TPX-0022 data update, we anticipate the initial update will focus primarily on safety as well as any early efficacy signals as we progress through our dose escalation cohorts.
Moving to our next upcoming milestones, we were pleased to have several abstracts accepted for presentation at the ASCO and AACR virtual annual meetings. Our ASCO poster will be a preclinical update for TPX-0046, scheduled for presentation on May 29, with abstracts planned for release tomorrow by ASCO. For AACR, we will present preclinical repotrectinib combination data and preclinical data for TPX-0131. We can now confirm that these poster presentations will be shared in late June at the second AACR virtual meeting. AACR plans to release abstracts for the presentations later this week, which should indicate the date and time of our presentations. The preclinical data for TPX-0131 is part of our ongoing work toward our goal of an IND submission by early 2021.
Now, let me turn the call over to Yi for an update on our financial results.
Yi Larson -- Executive Vice President And Chief Financial Officer
Thank you, Athena. You will see in our press release and financial tables that operating expenses for the first quarter were $62.6 million and included a one-time non-cash stock-based compensation expense of $31.4 million associated with modifications to the vesting of existing stock option grants as a part of the transition agreement of the company's scientific founder. Excluding this one-time item, non-GAAP operating expenses in the first quarter totaled $31.2 million compared to GAAP operating expenses of $14.1 million in Q1 of 2019 and $23.1 million in the fourth quarter of 2019. Primary drivers of the year-over-year increase were investments made to develop repotrectinib and the rest of our pipeline, including the headcount we have added.
Reported operating expenses included a total of $38.4 million in non-cash stock-based compensation expenses, primarily comprised of the $31.4 million one-time item. We continue to expect expenses in 2020 will increase, as we execute across four clinical trials for our three clinical stage assets and make investments to develop our ALK program and earlier stage discovery efforts.
Net cash used during the first quarter was $28.4 million and our cash, cash equivalents and marketable securities at March 31 were $380.8 million. We project our cash position will fund current operations into 2022.
With that brief update, I will turn it back to Athena.
Athena M. Countouriotis -- President and Chief Executive Officer
Thank you, Yi.
To close, I will summarize our goals for the year, which are: advancing enrollment in each of our clinical trials; the extent of the COVID-19 impacts on our clinical trial enrollments and data collection will depend on the duration of the pandemic; this is a clear area of focus for our team; presenting a preclinical update for TPX-0046 at the virtual ASCO meeting on May 29th; presenting our preclinical repotrectinib combination data and our preclinical data for TPX-0131 at the virtual AACR meeting in late June; providing an update of early interim data from initial patients in the TRIDENT-1 Phase 2 study during the second half of the year, potentially in the third quarter; we anticipate this update will include preliminary efficacy and safety data from approximately 30 patients to 40 patients across multiple Phase 2 cohorts, including registrational and exploratory cohorts; providing interim data from initial patients treated with TPX-0022 during the second half of the year; and advancing TPX-0131 toward IND submission, which we anticipate in early 2021.
Again, I want to thank our great Turning Point team for all they accomplished so far this year. This has been a challenging time with many rapidly evolving variables. Yet, our team adapted well and remains incredibly focused on delivering our pipeline to patients.
Operator, you may now open the line for questions.
Good afternoon, everyone. In addition to what we've outlined in our prepared remarks, earlier today, we announced that repotrectinib has been granted fast track designation by the U.S. Food and Drug Administration for the treatment of ROS1-positive advanced non-small cell lung cancer patients, who have not been previously treated with a ROS1 tyrosine kinase inhibitor. As a reminder, in January, repotrectinib was granted fast track designation for the treatment of ROS1-positive advanced non-small cell lung cancer patients, who had been previously treated with one prior line of platinum-based chemotherapy and one prior line of ROS1 TKI, a setting where there are currently no approved targeted therapies.
Our latest fast track designation was granted in ROS1-positive TKI-naive non-small cell lung cancer patients utilizing a July 22, 2019 data cutoff date, with a median follow-up of 20.1 months. Repotrectinib demonstrated overall response rate by blinded independent central review of 91% or 10 of 11 responders, with a median duration of response of 23.1 months. This is based on a Kaplan-Meier estimation. The probability of patients with a duration of response of greater than nine months was 78%; greater than or equal to 12 months, 65%; and greater than or equal to 18 months, also 65% respectively. Repotrectinib also showed a median progression-free survival of 24.6 months, which while not an endpoint of the Phase 1 study compares favorably with historical comparisons for the two currently approved agents in this setting.
As of April 6, 2020, with an additional 8.5 months of follow-up, four of the five responding ROS1 TKI-naive patients remained in a partial response per physician assessment data, since the July 22 2019 data cutoff, and the duration of treatment ranged from 9.2 months to 34.2-plus months with seven of the total 11% or 64% of patients remaining on repotrectinib. All seven patients remained on treatment for more than 17 months, 6% or 55% on treatment for more than two years, and 3% or 27% on treatment for more than 30 months at the time of the analysis. In addition, repotrectinib has also demonstrated CNS activity among patients with ROS1-positive advanced non-small cell lung cancer, who are ROS1 TKI-naive, with intracranial objective response rate of 100%, three of three patients, with durations of response as of the July 22 data cutoff of 14.8-plus, 17.6-plus and 23.1 months. All three of these patients remained on treatment as of the April 6, 2020 analysis, 26 plus months, 28.5 plus months and 34.2 plus months, which is very encouraging, given the limited therapeutic options for patients with CNS disease in this setting.
With that, additional information from our Phase 1 TRIDENT-1 study and our recent fast track designation now outlined, we may now open the line up for questions, operator. Thank you.
Questions and Answers:
Operator
Thank you.
[Operator Instructions]
Our first question comes from Paul Choi with Goldman Sachs. Your line is now open.
Corinne Jenkins -- Goldman Sachs -- Analyst
Hi, this is Corinne Jenkins on for Paul. I was wondering, if there's anything you'd point out on the repotrectinib label [Phonetic] approved last week, and whether you see any potential impact to the ongoing enrollment in your study of 0046 with the availability of an approved product [Indecipherable]?
Athena M. Countouriotis -- President and Chief Executive Officer
Hi, Corinne, thank you for the questions. I hope everything's OK with you and your family. Last week was a busy week, obviously with two approvals in the targeted oncology space. I think, we all anticipated the approval of selpercatinib or pralsetinib as you've outlined. I think I've consistently always said that I think it's a very good drug. I think those that may have detected changes as it relates to duration of response and/or warnings and precaution information, I'll leave that debate to them. But we've always been focused on how our drug differentiates. I think one of the ways, it clearly differentiates is also its selectivity as it relates to SRC and potentially to the safety components that we do not hit the VEGF3 and specifically VEGFR2, so there may be areas that we can differentiate versus the warnings and precaution labeling.
As it relates to the impact, one of the things that we were incredibly pleased with through the first quarter as well as moving into the second quarter, is how our Phase 1 studies have progressed. I think that's a testament to not only again the way that our molecules hopefully differentiate, which goes beyond just 046, but also that we have a global setting for our MET inhibitor and for that Phase 1 study, and also multiple sites for the RET program that you're asking about. So, an overall impact for the future is hard to predict, I think, equally as we've outlined from the duration of the pandemic. But so far, we've been very pleased with enrollment for not only the RET program but our other Phase 1 studies, which include the MET.
Corinne Jenkins -- Goldman Sachs -- Analyst
Thank you. And then, I would imagine that conferences like the ASCO and AACR have committed time for you to connect with KOLs that become involved in clinical trials, and I was just wondering if you could talk about how you're kind of maintaining some of those touchpoints given the shifts to a lot of virtual engagements?
Athena M. Countouriotis -- President and Chief Executive Officer
One of the things I would say is many of the KOLs have also unfortunately been adapting to the new environment and have been at home much more than they would have normally been. And so, I've been just as much online with some of the KOLs, who might have been more focused on clinic in the more recent past. So, I really don't believe that any engagement has changed at least from my perspective or, obviously, Mohammad, our CMO, has been incredibly engaged across all of our four ongoing programs. I think to your point, that you're right. It's unfortunate that we don't get the face-to-face for many of the major medical conferences. But I don't think in any way that it deters or distracts us as it relates to trying to connect with our key investigators as it relates to new drugs that are approved or obviously our ongoing studies.
Corinne Jenkins -- Goldman Sachs -- Analyst
Great, that makes sense. Thank you so much.
Operator
Thank you. Our next question comes from Jim Birchenough with Wells Fargo. Your line is now open.
Jim Birchenough -- Wells Fargo -- Analyst
Yes, hi, guys. Thanks for all the detail, and congrats on the progress through the difficult environment. I guess first, just on TRIDENT-1, going from 100 to 120 sites, is that just to offset the impact of COVID-19 or is there anything in terms of screening for ROS1- and NTRK-positive patients that you're seeing different than you'd assume previously?
Athena M. Countouriotis -- President and Chief Executive Officer
Thanks for the question, Jim. Same comment, I made to Corinne, hope everything is OK for you and your family. First, I would say that we were making the decision to evaluate additional countries throughout the conduct of the trial just looking back. Of course, had given a lot of detail through our Phase 1 updates in the context of our fast track designation that was granted today. So, I appreciate that's all new data. But to try to remind folks, our Phase 1 study was really seven sites, two countries. And so, the Phase 2 is just such a much more global scale program and we've been evaluating over time what additional countries we may or may not bring into the trial. So, going from a 100 to 120 actually included additional sites at the prior countries that we had selected, as well as some new countries that we've selected as we've learned more through outreach to KOLs in those areas, as well as outreach with our CRO. But, also to the point that you're making that I think trying to mitigate any potential impact down the road, we're obviously saying today that we've seen some delay as it relates to site initiations for the Phase 2. So, adding additional sites hopefully will help mitigate that if we can go inside further.
Jim Birchenough -- Wells Fargo -- Analyst
And then, Athena, just looking ahead to what may be an update in third quarter, but certainly second-half for TRIDENT-1, can you give us a sense is it still cohort two and three, where we'd expect the preponderance of patients? And that's just wondering if, to the extent you've had such as strong CNS response, have you enrolled patients that could confirm that activity? And maybe just to set expectations around what would you expect, if it is cohort two and three, what would be your expectations on this number of patients in terms of responses, we should look for?
Athena M. Countouriotis -- President and Chief Executive Officer
Sure. So, what we've outlined today and what we said at the beginning of the year was, right now in Q2, we give you more guidance as it relates to what to expect in the second half. And what we've tried to outline is, again, one of the things we said in the prepared remarks is that we're monitoring overall study conduct and data collection. And what I mean by that is, as you know, many sponsors have had to allow greater flexibility right now as it relates to patients potentially having local labs and/or local CT scans collected. It's now in our shop to get that data out of the local institutions into the treating centers, and then inevitably into our database. So, what we've said today is that we're potentially going to provide the second half update in third quarter, but we do still have to watch where we are with data collection.
And so, I can't fully answer whether it'll be cohorts two and three. What we've said today is that it will be multiple Phase 2 cohorts. And at the same time, to the question you've asked about CNS disease, it's too early for me to assess how much data I have collected in patients that have had intracranial disease. When I look at kind of how I should think about the data coming in the second half, it's really probably more to the point I made earlier about the difference between the Phase 1 study, two countries, versus now where we have 11 activated countries. Over half of those countries have now enrolled patients. And so, it's clearly a much more global trial, which to some may think that that would add more variability. And so, we want to look at an early number of patients to be able to assess not only a change from two countries to a much more global scale, but also as a reminder our Phase 2 dose is a regimen that allows titration after two weeks of 160 milligrams daily. You can go and double the dose to twice daily. And that we didn't explore in Phase 1, we explored it after a shorter period after seven days. So, my assessment when I think about the data, again to the point you've made, which is a relatively small data set, we're looking at approximately 30 patients to 40 patients, which is consistent. We always had early initial patients. I really just wanted to see the data obviously utilizing our Phase 2 dose in a much more global scale trial.
Jim Birchenough -- Wells Fargo -- Analyst
Well, thanks again for all that detail. And be safe, thanks so much.
Athena M. Countouriotis -- President and Chief Executive Officer
Thank you, Jim.
Operator
Thank you. Our next question comes from Michael Schmidt with Guggenheim. Your line is now open.
Michael Schmidt -- Guggenheim -- Analyst
Hey, thanks for taking my questions. And Athena, thanks for the detailed update today. It looks like the -- based on what you said the PFSs in the frontline treatment naive ROS1 patient cohort seems to mature really nicely. Good to hear that. Am just curious if you could also share any updates on potential treatment discontinuations from the Phase 1 study as you have taken a look at it more recently.
Athena M. Countouriotis -- President and Chief Executive Officer
Yeah, thank you for highlighting that, Michael. One of the things we clearly wanted to highlight, of course, we taped our prepared remarks. And so, we've received obviously very recently the fast track designation approval. And so, with that we provided an update to the FDA not only utilizing the July 2019 data cutoff, but also additional information that we've received utilizing physician assessment data. So, we've not looked at a formal blinded independent central review analysis since the July update from last year. Having said that, what you pointed out, I think there's two points I would point out. Previously, we had said that the maturity of the duration of response was not yet there and so that we had estimated that there was a high likelihood that 65% of it being at least 18 months.
Today, we've now said the at median has been met, and the median is 23.1 months, which again, if you're trying to do a historical comparison remembering crizotinib's duration of response, it's just over 18 months. I think for progression-free survival, at 24.6 months, again it compares historically to both the approved agents, which are essentially at 19 months. So, a delta, we were looking at 5.5 plus months. So, we're very pleased with the update as it relates to the Phase 1. All we've additionally commented on today is that all of the seven patients remain on treatment and we gave the extension, since what we gave in January, as to where our patients are with now multiple patients out over 2.5 years on drug, and only one patient that was in a previous response that has now subsequently progressed. So, that's what we gave in terms of the update as it relates to discontinuations.
Michael Schmidt -- Guggenheim -- Analyst
Makes sense, thanks. And then, obviously hard to predict at the moment and reacknowledging the additional sites that you're activating, but any additional color on when you think you might be able to complete enrolling the first registrational cohort? And how we should think about potential filing timelines?
Athena M. Countouriotis -- President and Chief Executive Officer
No, it's a very fair question. And we've consistently said is that we would give more guidance as it relates to the timeline. So, we have not yet given the timeline for the Phase 2 study. Yet, we would do that as we got closer to full site activation. Today, we've clearly said that we've made progress within the first quarter with now over 50% of our sites activated, but we've seen a little bit of a delay moving into Q2. So, it's a little hard to predict right now when we'll hit 100% site activation. But I do still believe that we'll be in a better position to provide you a timeline potentially for trial completion, once we have all of our sites activated and can truly assess the enrollment curve. So, it's a question I can't fully answer today.
Michael Schmidt -- Guggenheim -- Analyst
Thank you. And then, very nice to see the FDA approval recently of Novartis MET inhibitor capmatinib. It was very broad label, including front-line based on a very small study. I'm just wondering how you think about that in terms of readthrough to your program and potential longer-term plan with regards to path to market and how we should think about that as well as through the efficacy bar, maybe that Novartis sort of has set at this point?
Athena M. Countouriotis -- President and Chief Executive Officer
Sure. Yeah, last week, as I said before, was a busy week for precision oncology. And I think for those that don't do the math, unfortunately their lung cancer still remains the cancer that unfortunately has the highest rate of death, and it's actually higher than when you add breast, colon and pancreatic altogether. So, any advancements within the lung cancer space to me are incredibly positive. So two approvals last week was a big win for the field.
I think to the point that you're making, the data we've consistently seen is that there are ways we still believe we can differentiate as it relates to potentially prolonging duration of response, with that benchmark of about 12 months in the truly treatment naive patient population. Again, I think there were some that might've been surprised by some of the data as it related to the safety profile. And so for us, again, we will be interested when we do provide the update for our MET program, which we've said will still be within the second half. It will predominantly be a safety update. And, of course, we've always known that there is a high rate of peripheral edema with that asset.
And so, I think those are the ways when we look at their label, we still have the same belief and conviction we had before, as potentially to -- how we could differentiate. And then to your point, I think you're correct in the fact that it was a relatively small sample size that led to both of the indications.
Michael Schmidt -- Guggenheim -- Analyst
Well. Great. Thanks, Athena, and appreciate the update.
Athena M. Countouriotis -- President and Chief Executive Officer
Thanks very much, Michael. I hope everything is going OK for you.
Operator
Thank you. Our next question comes from Robert Burns with H.C. Wainwright. You line is now open.
Robert Burns -- H.C. Wainwright -- Analyst
Hi. Thanks for taking my questions, and congrats on the quarter and all the phenomenal progress Turning Point is making. Most of my questions have been answered already, but just one follow-up. So as we think about the development of all these assets, looking further on down the road and taking into consideration, the higher propensity for off-target resistance mechanisms and later generation TKI inhibitors, are you considering combining these assets with additional agents, for example, an SHP2 inhibitor later on in the development pathway? Thank you.
Athena M. Countouriotis -- President and Chief Executive Officer
Yeah. Sure, very good question. So I think, there was a question earlier as it relates to medical conferences and KOL engagement, I think it's important for us to highlight that we do have at least between the two conferences, ASCO, there'll be predominantly a preclinical update as it relates to our RET program, but AACR at the end of June will really be the first place where we start to show our combination strategy. We've talked about this for quite a while now. We've continued to work on it. We've built our team to evaluate multiple ways that we can combine at least our lead asset repotrectinib, but we're fully aware that there is another investigational RET inhibitor that's now being combined with an EGFR inhibitor.
So I think to your point, as we are looking at our entire pipeline and combinability with other targeted therapies, whether it's TKIs or others, but just something that we haven't necessarily shown publicly, but again, AACR abstracts will be coming out very soon and then subsequently, obviously, the presentation.
Robert Burns -- H.C. Wainwright -- Analyst
Awesome. Thank you.
Athena M. Countouriotis -- President and Chief Executive Officer
Thanks very much, Rob.
Operator
Thank you. Our next question comes from Jim Birchenough with Wells Fargo. Your line is now open.
Jim Birchenough -- Wells Fargo -- Analyst
Yes. Hi guys. Thanks for taking the follow-up. Just maybe a broader question. If you think about the profile, Athena, of your drugs, where you're hitting the wildtype mutation and the solvent front mutations, are there good categories that you can point to where that becomes the preferred front-line approaches? Is Tagrisso, Tarceva and lung cancer an example? Just want to get a sense of, as we start to think about what's going to be the dominant front-line agent over time and things like non-small cell lung cancer, if there's some precedent for something that hits wildtype and prominent resistance mutations? Thanks.
Athena M. Countouriotis -- President and Chief Executive Officer
Yeah. Sure, Jim. I think Tagrisso is a very good example, of course, for one that started in T790M and then moved clearly to the front-line based on its potency. I think one of the reasons -- and I know we've been asked repeatedly, and so I hope today's update will be perceived positively as the Phase 1 update for TKI-naive patients showing now the DOR of close to two years at 23 months and showing median PFS of over two years, where the competitors are at 19 months. I still think again it's the strongest data set that we have to show why we believe repotrectinib is the best-in-class agent, and clearly that's the drug that hits wildtype as well as it's the only currently that has activity in the clinic against solvent-front mutations.
So when we think about other benchmarks out there, we often use the example that you've outlined in Tagrisso. Sometimes we'll also look at ALK-enzyme [Phonetic], given the fact that it started in a different setting and now is really become the front-line agent for ALK-positive non-small cell lung cancer, but I think it's a very fair point to think of how we think each of our molecules not only differentiate for treatment resistance, but also can be best-in-class.
Jim Birchenough -- Wells Fargo -- Analyst
Great. Well, thanks for taking the follow-up.
Athena M. Countouriotis -- President and Chief Executive Officer
Thanks, Jim.
Operator
Thank you. [Operator Instructions] Our next question comes from Zegbeh Jallah with ROTH Capital Partners. Your line is now open.
Zegbeh Jallah -- ROTH Capital Partners -- Analyst
Hi. Just wanted to ask a quick question about any regional differences in the enrollment for TRIDENT, and then, kind of, get a sense of how that may overlap with sites where you're seeing more of an impact of COVID-19?
Athena M. Countouriotis -- President and Chief Executive Officer
Yeah, thank you for the question. So first, I think it's -- as it relates to the Phase 1 versus the Phase 2, let me just say from the Phase 1 component, it was two countries, so United States and South Korea. The largest enroller within the Phase 1 was here within the United States at Sloan Kettering. Our Phase 2, we've not given any guidance as it relates to periodic enrollment or where enrollment is coming, but what I did say today is we have 11 activated countries now and over half of them have enrolled patients within the Phase 2. So I haven't given you specifically the countries, but I have at least given you information to say that it is a broad base of where enrollment has already started within the Phase 2 study. So that's the best way that I could answer the question, as it relates to enrollment as of today.
Zegbeh Jallah -- ROTH Capital Partners -- Analyst
That's helpful. Thanks. And then another follow-up here. Just wanted to also get a sense of how many scans or what the median treatment duration will likely be for the data update that might happen in Q3 for TRIDENT Phase 2?
Athena M. Countouriotis -- President and Chief Executive Officer
Yeah. That's something that we're currently evaluating now, given the fact that we have multiple patients who have data that is still being collected from local institutions. So I would be able to give you any further guidance as to whether patients will have more than one or two post-baseline scans in the context of what the update will be, because it will also be dependent on when the update will be, whether it will be in Q3 or later in the second-half.
Zegbeh Jallah -- ROTH Capital Partners -- Analyst
Got it. Thanks, Athena.
Athena M. Countouriotis -- President and Chief Executive Officer
Of course. Thanks for the questions.
Operator
Thank you. Our next question comes from Arlinda Lee with Canaccord. Your line is now open.
Arlinda Lee -- Canaccord -- Analyst
Hi, guys. Thanks for taking my questions. I had -- maybe -- I was looking for maybe additional color on some of the data sets that we might be expecting toward the end of the year. You mentioned that you were looking for 30-ish to 40-ish patients in exploratory and registration arm. I was curious since the trial started late last year -- or sorry, middle of last year again -- are those patients then going to largely not be impacted by COVID? And then, I was curious about -- if you anticipate any issues from requiring biopsies fresh versus maybe archival and whether there's any change to the workup of these patients, during this time? Thank you.
Athena M. Countouriotis -- President and Chief Executive Officer
Yeah, thanks. Thanks for the questions, Arlinda. We actually had previously guided and have outlined it again in some of our documents that currently for enrollment patients can come in with local testing. So there is no current requirement for a fresh biopsy, of course, unless the patient is a naive patient who has just recently been diagnosed. So the biopsy components hopefully is not a barrier for patients that are coming through within the trial.
The impact as it relates to the data analysis, again, it will be partially based on the last question as to where we're with current stance and where the patients were in their treatment paradigm to fully be able to answer your question. So I can't answer entirely whether any of the patients that will potentially be in the dataset will have had scans during this time, more than likely they would have. But again, the question I think you're asking is, patients that we had enrolled. Your timeline was correct. The studies enroll started in July of last year, but only early patients versus more recent patients. Again, why we are looking at overall conduct and data collection, it's a question that's hard to answer right now.
Arlinda Lee -- Canaccord -- Analyst
Okay. Thank you.
Operator
Thank you.
Athena M. Countouriotis -- President and Chief Executive Officer
Thanks very much. Okay.
Operator
I'm not showing any further questions at this time. I would now like to turn the call back over to Athena Countouriotis for closing remarks.
Athena M. Countouriotis -- President and Chief Executive Officer
Well, thank you again everybody for dialing in. I really appreciate the time and, obviously, your interest and support in Turning Point Therapeutics. Given the Company is under the stay-at-home directive, I know many of our employees are at home, and so, I thank you for everything that you have been doing, you know that. I hope you and your families stay well during all of these unprecedented times.
And operator, you may now close the call. Thank you.
Operator
[Operator Closing Remarks]
Duration: 41 minutes
Call participants:
Jim Mazzola -- Senior Vice President, Communication And Investor Relations
Athena M. Countouriotis -- President and Chief Executive Officer
Yi Larson -- Executive Vice President And Chief Financial Officer
Corinne Jenkins -- Goldman Sachs -- Analyst
Jim Birchenough -- Wells Fargo -- Analyst
Michael Schmidt -- Guggenheim -- Analyst
Robert Burns -- H.C. Wainwright -- Analyst
Zegbeh Jallah -- ROTH Capital Partners -- Analyst
Arlinda Lee -- Canaccord -- Analyst
