Turning Point Therapeutics, Inc.
Q4 2020 Earnings Call Transcript

Published: 1 Mar 2021

[Operator:]

Ladies and gentlemen, thank you for standing by and welcome to the Turning Point Therapeutics' fourth quarter 2020 conference call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. . I would now like to hand the conference to your speaker today, Mr. Jim Mazzola, Head of Investor Relations. Thank you. Sir, please go ahead.

[Jim Mazzola:]

Okay. Thank you. Good afternoon everyone. Following market close today, we filed our Form 10-K and issued a news release with a summary of our results for the fourth quarter and full year 2020. We also updated our investor presentation and you may find these documents posted on the Investor pages of 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. 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. The three of us are in separate locations today. So please bear with us as we manage the call remotely. 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. And 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 update over to Athena.

[Athena Countouriotis:]

Thank you Jim and good afternoon to everyone joining us on today's call. Today, I want to briefly recap our progress in 2020, share a number of updates across our programs and focus on our goals for 2021. Overall, we continue to make progress in developing our four internally discovered next-generation tyrosine kinase inhibitors that target genetic drivers of cancer. In addition, we are investing in a discovery engine with the goal of polishing a pipeline for long term growth. The progress and investments we have made are all directed toward advancing our vision to be the leader in a precision oncology. Starting with our lead program, repotrectinib. In 2020 and in January 2021, we reported encouraging preliminary data from our registrational Phase 2 TRIDENT-1 study. Repotrectinib is a next-generation ROS1 and TRK TKI, with greater than 90-fold higher preclinical potency than crizotinib and greater than 50-fold higher preclinical potency than entrectinib against wild type ROS1. Repotrectinib has been granted several key regulatory designations, including breakthrough therapy designation in the United States for the treatment of patients with ROS1-positive, TKI-naïve metastatic non-small cell lung cancer. To recap our clinical data updates which we believe support a potential best-in-class profile, as of an December 31, 2020 data cutoff date in 15 ROS1-positive, TKI-naïve advanced non-small cell lung cancer patient, we have had at least two post baseline scans in the Phase 2 portion of the TRIDENT-1 study. The confirmed objective response rate by physician assessment was 93% or 14 of 15 patients with a 95% confidence interval of 68 to 100. At the time of the data cutoff, the one non-responder remained on treatment with a 13% tumor reduction. In 22 patients pooled from the Phase 1 and Phase 2 portions of the TRIDENT-1, the confirmed overall response rate was 91% with a 95% confidence interval of 71 to 99. For historical reference, both Xalkori and Rozlytrek are approved in this patient population with confirmed overall response rate of 66% and 67% by blinded independent central review respectively. Equally important is the duration of treatment and in the pool Phase 1 patients, the duration of treatment ranged from 10.9 to 37.3 months with a median of 30.9 months which we find encouraging given it compares favorably to the published data for Xalkori with a median duration of treatment of 22.4 months.

[Yi Larson:]

Thank you Athena. You will see in our press release and financial tables that operating expenses for the fourth quarter totaled $47.9 million compared to $23.1 million in the fourth quarter of 2019. The $25 million increase was driven by a $17 million increase in R&D expenses and an $8 million increase in G&A expenses. Increased expenses were attributable to the investments we made to develop our pipeline in earlier stage discovery and in personnel.

[Athena Countouriotis:]

Thank you Yi. To close, I will summarize our goals for 2021, beginning this month, with our anticipated submission of the IND for TPX-0131, our novel ALK inhibitor. We have a busy second quarter expected with anticipated milestones, including reaching enrollment of 50 patients in cohort one of the TRIDENT-1 study and discussing next steps towards registration in this population with the FDA. In addition, reporting early interim data for TPX-0046, initiating the TPX-0131 Phase 1/2 clinical study and multiple pipeline presentations at medical conference. Moving on to mid-year, we expect to initiate the first cohort of our TRIDENT-2 combination study. And in the second half, we anticipate providing an enrollment and clinical data update in other cohorts of the TRIDENT-1 study, providing a clinical data update from the Phase 1 portion of the SHIELD-1 study and initiating the Phase 2 portion of the study, initiating the SHIELD-2 combination study and finally outlining our research strategy, including our focus and anticipated timeline to developing a candidate. With that update, we are now ready to take your questions. Before we do, I want to close by thanking our great and growing Turning Point team for all they accomplished in 2020. We are looking forward to another great year in 2021. Operator, you may now open the line for questions.

[Operator:]

. And ma'am, you have your first question from Michael Schmidt of Guggenheim. Sir, please ask your question. Your line is now open.

[Michael Schmidt:]

Hi guys. Thanks for taking my questions. Athena, I had one on repotrectinib and maybe more specifically around the ROS1 market and maybe was just wondering if you could maybe share from your experience enrolling the TRIDENT-1 study what you are seeing at the moment in terms of what percentage of patients is actually receiving an approved ROS1 TKI versus being treatment naïve? It seems like your TKI-naive cohort is enrolling pretty quickly here. I am just wondering if you could comment on that. And then I had a follow-up as well.

[Athena Countouriotis:]

Yes. Hi Michael. I am happy to do so. So our belief is that ROS1 market remains at approximately 2% of non-small cell lung cancer. And I will say we have gone through with the leadership of our Chief Commercial Officer a very large market research campaign internally to help prepare us for hopeful potential registration and commercial launch for repotrectinib. And it does appear that, at least in the United States that crizotinib is still the standard of care and there's been very little change in the annual sales for crizotinib year-over-year. That said, the uptake as well appears to us modestly improved but I still would say that it's a modest launch, at least a year now into its commercial opportunity. That said, as it relates to enrollments for our trial, definitely we are the most pleased in that our cohort one has exceeded our initial projections despite the competition, obviously, that's in the commercial landscape. So that's why we have been very much focused there. Of course, we have gotten breakthrough therapy designation there and now moving as quickly as we can to the Type B meeting with the FDA.

[Michael Schmidt:]

Great. Thanks. And then on to TPX-0046, your RET inhibitor, you obviously have activity against solvent front mutations. And I was just wondering if there are any other characteristics that could potentially address potential shortcomings of currently approved RET inhibitors? And how investors should be thinking about the upcoming Phase 1 update in terms of interpreting the data that we will get there?

[Athena Countouriotis:]

So as it relates to 046, what we have consistently shown is that it is equally important to the other two molecules based on our preclinical studies in the wild type setting and again at that point you mention on solid front mutation that 046 is more potent, specifically against certain solvent front mutations. That said, we have very limited information as it relates to the prevalence of those mutations but clearly have been enrolling patients who not only are TKI pretreated but also have solvent front mutations as well as patients who are TKI naïve. The trial has essentially been enrolling for approximately a year on a standard three-by-three design. Where we are today is continuing to evaluate additional doses and schedules. We try to guide today to anticipate similar to what we did with the MET program of the mid-teens and we estimated 15 to 20 patients in the initial update. But we have been consistent in saying that the first update really will focus predominantly on safety as well as any early signals of efficacy across multiple doses.

[Michael Schmidt:]

Great. Thank you so much.

[Operator:]

And ma'am, you have your next question from Paul Choi of Goldman Sachs. Sir, please ask your question. Your line is now open.

[Corinne Jenkins:]

Hi. This is Corinne Jenkins, on for Paul. As you do your combination studies of repotrectinib and KRAS-mutant solid tumors, can you just talk about where you see the clinical hurdles for combination program? And especially, given there is a lot of development in that are these days?

[Athena Countouriotis:]

Yes. Hi Corinne. And please say hello to Paul for us. So the first thing I would say is, we have been very pleased with the progress we have been making, not only within the combination preclinical data sets that we been developing around repotrectinib, but towards initiation of the trial. We gave a little bit more information today to highlight this is going to be a multiarm trial. We will initiate the first cohort in the middle of this year. Our goal obviously is to submit the IND relatively soon to enable that. And we don't typically give too much guidance as it relates to trial design until our INDs are submitted and ultimately filed. But we do have more data coming at a medical conference in the second quarter, I am sure you anticipate which conference that is, to support his. And I think much of the data we have shown so far is in combination with AMG510 in a G12C setting. We have also shown data with trametinib in the G12C setting. So without trying to forerun too much on what we think the clinical hurdle will be, I think it will be important for us to show you the design as it relates to which combination partner we are using and then we can start talking in terms of what we hope anticipate showing as it relates to response rate, duration and safety.

[Corinne Jenkins:]

Okay. That's fair. And then as you think about the upcoming Type B meeting, can you just talk a little bit about the key questions you would like to get answered and where you would like to be exiting that conversation?

[Athena Countouriotis:]

Yes. So of course the Type B meeting is exclusively focused on cohort one which is our ROS1 TKI-naive population. And that's because this meeting was requested in the context of breakthrough therapy designation. And while it's not a pre-NDA meeting, we do have an extensive briefing document that outline our preliminary clinical pharmacology studies, our CMC plans, our companion diagnostic plans and the patient population. And inevitably, I think the key component here is to try to get some guidance and potentially clarify regulatory path for cohort one as it relates to number of patients and one follow-up. As you know, we designed the trial to mirror crizotinib and entrectinib which had essentially 50 patients in their initial application. And our current guidance is that we will have 50 patients in the second quarter. So there are quite a few questions we hope to get answered. I won't say I have been trying to be conservative here in saying that this is the first meeting since having BTD. So it's a preliminary discussion and you obviously don't have as much until you have the pre NDA meeting. But I do think any additional information we can receive in terms of regulatory clarity will be very helpful at this point.

[Corinne Jenkins:]

Great. Thank you.

[Jim Mazzola:]

Okay. Next question, operator?

[Operator:]

Yes. Thank you, sir. Your next question is from David Nierengarten of Wedbush Securities. Sir, you line is open. Please ask your question.

[David Nierengarten:]

Hello. Thanks for taking the question. It's a little bit of a follow-up to the previous one which is, when you think about potential combinations, KRAS, AMG510 as one, you mentioned trametinib. Kind of, maybe if you wanted to elaborate a little bit on your strategy for expanding the potential reach here. Are you planning to have a multi-prong approach? Are you just looking at these first two and progressing through approval, eventually and then looking at additional combinations? I am just kind of curious, as you think about sequencing potential combination studies, what your priorities are and what that might look like over the medium-term of, let's say, a couple years from now? Thanks.

[Athena Countouriotis:]

Yes. Hi David. So let me just start with repotrectinib because obviously this is the year where we are going to initiate two combination studies. The first for repotrectinib, again, is trying to take advantage of the fact that it also has strong potency against JAK2, SRC and FAK which, as I mentioned in the prepared remarks, do suppress STAT3 and AKT signaling. So the goal here is in a KRAS pathway to try to hit bypass resistance multiple ways. What we have shown publicly so far and again trying not to jump too much of a medical conference that's coming, we have more data coming in our combination strategy but what we have shown previously is what AMG510 in G12C setting and trametinib. We do have more data with other G12C inhibitors. We do have more data with other MET inhibitors. And so right now, all we are publicly guiding to is that the initiation of this trial will occur in the middle of 2021, pending FDA filing and that it will be a multiarm approach. And how many drugs will be a part of this trial is still to be determined. The trial will initially start in KRAS-mutant solid tumors and then potentially narrow down into non-small cell lung cancer and to our colorectal and pancreatic cancer setting. But that's all still again to be determine. And I am sorry, but I can't give too much more. This is kind of against our standard practice.

[David Nierengarten:]

That's fine. It's a competitive space, I know. Thanks.

[Operator:]

And ma'am, your next question is from Matt Biegler of Oppenheimer. Sir, your line is open. You may ask your question.

[Matt Biegler:]

Hi. Thanks for taking my questions. I had a question going back to the SHIELD trial eligibility. It's one I get inbounds on. So for MET amplified patients, did you exclude copy number locations, I think similar to what we have seen some of capmatinib's recent data?

[Athena Countouriotis:]

No. And thanks for the question, Matt. So just as a reminder, thanks for fielding questions, of course. The Phase 1 SHIELD-1 study essentially is a trial that's open to all MET alterations. And so, this by far has the majority of patients with non-small cell lung cancer. But as you saw from our updates last fall, we have enrolled multiple GI tumors, whether it's gastric cancer, hepatocellular, colorectal. I can tell you we are continuing to enroll other cancer types, including GYN tumors. And so it's open, irrespective of gene copy number for MET amplification. It's open to exon 14 mutations, of course. And then it's also open right now to kinase domain fusion. As we move towards the recommended Phase 2 dose, which we are anticipating now will be within the second quarter and move directly into Phase 1 dose expansion, this is where we will narrow down the patient population into select cohorts. We may, at that time, change the criteria to have a cutoff, to your point on gene copy number. We have not made that determination yet, but we will, for sure, decrease the amount of prior chemotherapy. For the lung cancer MET amplified patients that were enrolled in the initial update that we gave last fall, the median was three prior therapies, but again these patients had more like four or five rounds of prior chemo and/or immunotherapy. So those are the patients that will now potentially be excluded from the expansion. But no is the answer to your question. We did not exclude patients based on gene copy number.

[Matt Biegler:]

Great. That's really encouraging. Maybe just a quick follow-up, if I may. Just something more on broad here as you think about expanding the pipeline. Do you foresee focusing exclusively on macrocyclic scaffolds in the future? Or are you thinking about being more agnostic to really any type of structure or type of TKI?

[Athena Countouriotis:]

Thank you for the follow-up. The company obviously, at this point, is very well known for our four drug candidates that all came off of the initial macrocyclic scaffold. I can tell you, our Chief Scientific Officer, Siegfried, has been not only minding that but also looking at other opportunities when he is evaluating targets for future development candidates. So right now, I would say that we do plan on continuing to evaluate our macrocyclic scaffold but I would also not be surprised if we were to go down a lightly different path but with the same idea of trying to maintain low molecular weight as well as highly potent potentially best-in-class and/or first-in-class drug candidates.

[Matt Biegler:]

Thanks Athena and congrats on the progress.

[Athena Countouriotis:]

Thank you very much, Matt.

[Operator:]

And ma'am, you have your next question from Nick Abbott of Wells Fargo. Sir, your line is open. Please ask your question.

[Nick Abbott:]

Hi. Good afternoon and thank you very much for a very well decked update. Maybe just a quick question on 131. You have indicated that this molecule has good brain penetration and it look like on the quarter deck that you are allowing patients with asymptomatic brain metastases. Do you think you will see more of those kinds patients, given the CNS penetration with this molecule and perhaps they could go for a Phase 1 trial?

[Athena Countouriotis:]

Well, thanks for the question, Nick and congratulations for you. I would say one thing first of all. Let me just start. I am excited about the ALK inhibitor because I think in many ways it mirrors repotrectinib the most when I look at our pipeline. It is not only very potent in the wild type setting and what you have seen on that corporate deck is somewhere 10 and 30-fold more potent than the second gen TKIs which you would say alectinib is the standard of care. Equally, we are getting over 100-fold more potent for G1202R. So again, it's a similar story to what you saw with repotrectinib and again of course, repotrectinib has CNS penetration. So I don't know if the patient population will be skewed in that direction initially. What you see on the slides, we have a little bit of information on the trial design, is that we will limit down the number of prior TKIs and chemotherapy. This is all up for FDA discussion still, of course, because the IND has not been submitted. But I don't know specifically which patients we will key in terms of CNS disease or not. I will say that we are hoping to got through does escalation as quickly as possible. We didn't get too much quite into it yet but the goal is to try to use some type of a single patient dose escalation and go as fast as we can to IND.

[Nick Abbott:]

Okay. Thank you. And then maybe just a follow-up on that. When you think about trying two combination study, how far the JAK2 inhibits repotrectinib? And part of the question relates to the fact that you do see anemia as a Grade 3 treatment related to adverse event as that related to JAK2. And they are all JAK2 and it's bearing down mediated efficacy and there's PD-1 resistance. So is there a concern that it could be potent and interfere perhaps with potential PD-1 combinations?

[Athena Countouriotis:]

Yes. First of all, it's a fair question. Let me maybe back step on the anemia component first and then I can go to the potency. So one thing we have seen with the initial data set, remember, for our safety profile which we showed of 185 patients, about half of that was coming from the Phase 1. And remember, of the Phase 1, about a third came from heavily pretreated ALK patients. So the majority of patients were that had anemia came in not only with some light type baseline, low hemoglobin, but also were heavily pretreated ALK patients. When you look at the in vitro potency data we have for ROS1, of course, we are sub-nanomolar and for JAK2 we are about one nanomolar. So it is not as strong as a JAK2 inhibitor, obviously as it is a ROS1 inhibitor, but still incredibly potent. So we will have see in terms of the translation into the clinic, to your point, of JAK2 inhibitors being unfortunately prone to anemia.

[Nick Abbott:]

Okay. Thank you very much.

[Athena Countouriotis:]

Thanks Nick.

[Operator:]

And ma'am, you have your next question from Zegbeh Jallah of ROTH Capital Partners. Your line is open. Please ask your question.

[Zegbeh Jallah:]

Hi guys. Thanks for taking my question. The updates have been really good. I wanted to just start with repotrectinib. I just kind of wanted to know how much data do you think you will at the time of your Type B meeting? I know you talked about having data on 50 patients. But what would perhaps be minimum duration of follow-up at the time of the meeting? And then are we likely to expect an NDA initially on cohort one and then the other cohort to follow the label expansion?

[Athena Countouriotis:]

Hi Zegbeh. Thanks for the question. So we are putting the briefing document together now. So I can't give too much information as it relates to the duration of follow-up. What I do feel comfortable saying is, the FDA will be seeing slightly more data than what you seen from World Lung. But again, it's a follow-up. It's not the more important component. It really is where we are with response rate, confidence interval, duration of response and the overall safety profile for the totality. The follow-up, of course, will be important as we get closer to NDA submission. Regarding to your second question, at this point we can't predict where we will be in terms of what indication we will go in first because to some extent, that will be dictated by the conversation we are going to have at the Type B for frontline. But we are pleased with the way that the other cohorts are enrolling as well. So more to come. Of course, the Type B meeting is in second quarter and pending minutes, we will give guidance as to the outcome of that call.

[Zegbeh Jallah:]

Okay. And then the last question is just about how helpful has Zai been in terms of broad improvement across TRIDENT-1? And then it does seem, from my perspective, at least that the partnership for 0022, they happen a little bit sooner. So I was just wondering, are they going to be a lot more involved with the clinical development of that program?

[Athena Countouriotis:]

My apologies, Zegbeh. My team is on Polycom on my side in the office here. I couldn't hear the first part. I heard the second part as it related to 022. But was there a first part of your question?

[Zegbeh Jallah:]

Yes. The first part was just about how helpful has Zai been in terms of broad improvement for TRIDENT-1 so far?

[Athena Countouriotis:]

Okay. Understood. Thank you. So Zai Lab reported this morning and they announced that they will be participating in TRIDENT-1 in the first half. So what I would say is that they have been incredibly helpful is not only helping us understand more the market in their region, which obviously they are the experts in my opinion in that region and getting us prepared to initiate the trial within Greater China. That's what I could say as it relates to repotrectinib. You are right in that the 022, I think I heard your second part. You are right in that the 022 collaboration was signed earlier and that we had less patient data. But remembering that when we originally signed with Zai Lab, they did a right of first initiation for other assets within the pipeline. So it was always my thought that if the MET data was encouraging, especially given the prevalence of gastric cancer within China, that that would be a collaboration that could benefit us both. So I was not surprised in any way that that one was signed with much less clinical data. And I think if you were to speak to Samantha, I think she would also say, I have been on call with here recently, that it was also a testament to how she has seen the team deliver. So I don't know if I can predict too much in terms of faster pace of additional collaborations. Of course, we maintain worldwide rights for the other assets in the pipeline.

[Zegbeh Jallah:]

Thanks Athena.

[Athena Countouriotis:]

Thanks Zegbeh.

[Operator:]

And ma'am, you have your you next question from Silvan Türkcan of JPM Securities. Please ask your question. Your line is now open.

[Silvan Türkcan:]

Hi. Thank you very much for taking my questions and congrats on the quarter. I see that you talked about initiating SHIELD-2, the combination study of TPX-0022 with EGFR in the second half of this year. Could you tell us if this could also become a multiarm study similar with repotrectinib with TRIDENT-2 where you actually add a couple more compounds to this? And also what are your objectives for the EGFR combo, in terms of the setting and tumor types you are looking for?

[Athena Countouriotis:]

Well, first thanks for the question. I know you are not at JPM. You are at JMP. So I am sure that gets unfortunately done quite often. Sorry for you. Unfortunately, it not our standard practice to give too much in terms of trial design prior to IND submission. And my approach is really until IND filing by the FDA. So I think you are right on track with our thoughts in terms of there are potentials for multiple EGFR inhibitors whether they are bispecifics or TKIs to include in a MET combination. We just haven't given that guidance yet. And that unfortunately also segues to the second part of your question of whether we will be using this in patient who have already progressed or frontline, we haven't given that guidance yet. But again, as the study gets closer to initiation and IND clearance, we will give more in terms of the study design.

[Silvan Türkcan:]

Okay. Thanks. And then maybe one of a hypothetical question for you on KRAS strategy. What do you think is the best way these days to develop a KRAS combo. There are multiple companies out there with KRAS and they have multiple combinations. Would you eventually want to have a firm strategy or partnership? Or do you think it would just development side-by-side with multiple KRAS compounds? What do you is the best strategy?

[Athena Countouriotis:]

Well, I would just speak to the data that we have currently which of course is with one of the two G12C inhibitors. That's what we have shown publicly in the preclinical setting and one commercially available MET inhibitor. But again, all I can say at this point is that we are already saying now that our trial will be multiarm. So you know that there will be more than just one drug that we are combining repotrectinib with. We are just not saying yet which. I do think that there is lessons to be learned with SHP2s and others that are currently ahead of us taking probably a different approach potentially on a different pathway. Of course, we are not targeting SHP2. We are targeting JAK2, SRC and FAK. But really much more to say about the trial design once the IND is filed.

[Jim Mazzola:]

Okay. Great. I think we have our last question now, operator.

[Operator:]

Yes, sir. We have our last question from Arlinda Lee of Canaccord. Ma'am, please ask your question. Your line is now open.

[Arlinda Lee:]

Hi guys. Congrats on the progress. I had maybe a follow-up question on your FDA meeting. Considering, I think FDA saw less than a dozen patient worth of ROS1 naive patients when they granted the breakthrough designation. And now that you have 50, I am curious, what exactly are you guys looking for from their feedback? Or what gating do you think is to filing. I know you want to be conservative ahead of chatting with them. But is there a durability question, do you think? Do you think you might need additional patients? And are those sites continuing to enroll naive stations? Thank you.

[Athena Countouriotis:]

Let me make sure I heard the last part. What was your last part, Arlinda? I am sorry. You were tailing off. Something about enrollment?

[Arlinda Lee:]

Yes. Are you continuing to enroll TKI naive patients, a ROS1 TKI-naïve patients?

[Athena Countouriotis:]

Okay. Sure. So let me respond to the first part. First of all, looking at small sample sizes, of course as each of the data updates have come, hopefully you have seen it, specifically from last August where we only had the seven patients to the most recent update, a tightening of the conference interval and specifically of the lower bound and that's important. And so I think that's an important component to bring to the FDA. But also at the same time, just as a background, receiving breakthrough therapy designation in December of last year, the FDA asked us to have a Type B meeting within six months. And so this is really now the opportunity for us to discuss with the Head of the division our overall path. And that includes, as I said, much more than just the number of patients. It's where we are with our clinical pharmacology study, healthy volunteer studies, DDI studies, hepatic impairment studies, CMC, where we are with our formulations, where we are with our companion diagnostic and of course where we are in terms of the patient data. So there is quite a bit to get initial feedback from because remember, at this point, we have had an end of Phase 1 meeting with the agency and we had a Type C meeting last August, which was focused more on the pretreated and follow-up and pooling of Phase 1 and Phase 2 patients. So this level of conversation that we are going hopefully have is much more than we had before. And so it's an important meeting, it's much more than just the number of patients or duration of response. As it relates to the key question for NDA timeline, that's important just to really understand is there any difference from the prior guidance, which is the guidance they have given us today, is that approximately 50 patients with a minimum of 12 months of follow-up, half the last responder to support standard approval. So that's a key question for us to try to understand if there is any difference there as well based on our emerging data. But it's a much bigger meeting than just discussing number of patients, duration of response, et cetera.

[Arlinda Lee:]

Great. That's super helpful. And then on the enrollment of, continuing to enroll naive?

[Athena Countouriotis:]

My apologies. Yes, I am sorry. I didn't answer that. I am sorry. So I mentioned in January, we had actually 40 patients. We have guided that in the second quarter we anticipate we will have 50 patients. And I had also recently said that even after we get to the 50 patients, we will continue to enroll TKI-naive patients, especially to help benefit our partner in Zai Lab who obviously are coming into the trial at a time where we are getting close to enrollment completion within cohort one. So we will, yes, continue to enroll. And that's also important if you look at all of the precedent with the approved two RET inhibitors and the two approved MET inhibitors as well as Rozlytrek, all five of those approvals, there were more patients and more follow-up that the agency required in the context of their approval letters. And so that will be something we will also mirror.

[Arlinda Lee:]

Thank you very much.

[Athena Countouriotis:]

Thanks Arlinda.

[Operator:]

And speakers, so it would be our last question for this call. Turning back over to Ms. Athena.

[Athena Countouriotis:]

Thank you very much, operator. Thank you everybody for dialing in today and of course for your interest and support of Turning Point Therapeutics. I hope that all of you and your families remain safe and continue to stay well. I was incredibly happy to see many of our employees today in the office. And I will just say, personally, I can't wait to hopefully to see all of you face-to-face in the near-term. Operator, you may now close the call. Thank you very much.

[Operator:]

Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you all for joining. You may now disconnect.