Image source: The Motley Fool.
Seattle Genetics Inc (SGEN)
Q2Â 2019 Earnings Call
Jul 16, 2019, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good day, ladies and gentlemen, and welcome to today's Seattle Genetics Second Quarter 2019 Financial Results Conference Call. Today's conference is being recorded. For opening remarks, I'd like to turn the conference over to Peggy Pinkston, Vice President of Investor Relations. Please go ahead.
Peggy Pinkston -- Vice President, Investor Relations
Thank you, operator, and good afternoon everyone. I'd like to welcome all of you to Seattle Genetics second quarter 2019 conference call. With me today are Clay Siegall, President and Chief Executive Officer; Robin Taylor, Chief Commercial Officer; Todd Simpson, Chief Financial Officer; and Roger Dansey Chief Medical Officer.
Accompanying today's conference call are supporting slides, which are available on our website in the Investors section, Events and Presentations page.
Following our prepared remarks today, we'll open the line for questions. We ask that you limit yourself to one to two questions to ensure we're able to get to everybody during our call today.
Today's conference call will include forward-looking statements regarding future events or the future financial and operating performance of the Company, such as those among others relating to the Company's 2019 financial outlook, including anticipated 2019 ADCETRIS sales and future revenues, cost and expenses, and the Company's potential and anticipated timing to achieve future, clinical and regulatory milestones, including data readouts, regulatory submissions, and approvals.
Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Among the factors that may cause such a difference include the difficulty in forecasting sales, revenues and expenses, and the uncertainty associated with the pharmaceutical development and regulatory approval process.
More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the Company's periodic reports filed with the Securities and Exchange Commission including the Company's quarterly report on Form 10-Q for the quarter ended March 31st, 2019.
Now I'll turn the call over to Clay.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Thanks, Peg, and good afternoon, everyone. In the past few months, we've delivered on several important goals focused on growing our flagship brand ADCETRIS and continuing our evolution into a multi-product oncology Company. Our late-stage portfolio includes enfortumab vedotin, which have been submitted to FDA for approval in metastatic urothelial cancer based on the positive outcome of the EV-201 trial.
In addition, we're advancing two other programs in pivotal trials. Tucatinib in HER2-positive metastatic breast cancer and tisotumab vedotin in metastatic cervical cancer. I'll begin with some comments on ADCETRIS, which is an important global product for the treatment of lymphoma.
Under our collaboration with Takeda, it is now available in 73 countries. In the US and Canada, we reported record ADCETRIS net sales of $159 million in the second quarter, up 18% from the first quarter of the year. This growth was mainly driven by increased utilization in frontline peripheral T-cell lymphoma. There were -- there was also increased use in frontline Hodgkin lymphoma. In addition, these results reflect second quarter strength that we have previously seen with ADCETRIS. We will provide more detail on our commercial progress later in the call.
Outside the US, we and our partner Takeda, are continuing to expand the approved indication for ADCETRIS. In frontline Hodgkin lymphoma, we received Canadian approval in May and Takeda recently received approval in a third key country outside of Europe and Japan. This triggered a milestone payment to us of $7.5 million. To date, we've achieved a total of $118 million in milestones under our collaboration, including $47.5 million related to frontline Hodgkin lymphoma approvals in Europe, Japan and key countries.
For frontline PTCL, we submitted our approval application to Health Canada in May and Takeda also plans to submit frontline PTCL for approval to the EMA and other health authorities this year.
Next is enfortumab vedotin or EV, which we're developing in collaboration with Astellas. Today, we announced the BLA submission to the FDA for accelerated approval of EV in metastatic urothelial cancer based on results from the EV-201 study. The data were featured in an oral presentation at ASCO and selected for an ASCO press briefing. We are encouraged with the positive reception to these data by the physician community.
In anticipation of potential approval, our launch preparation is rapidly advancing. EV is positioned to become our next marketed drug, and if approved, will expand our commercial portfolio beyond hematologic malignancies into solid tumors. We are working closely with Astellas to advance and expand the clinical development program for EV including in first-line metastatic urothelial cancer. Roger will recap the EV-201 results as well as the clinical development plan during his remarks.
We're also advancing two other solid tumor candidates in late-stage development. These include Tucatinib in HER2-positive metastatic breast cancer and tisotumab vedotin or TV in metastatic cervical cancer. We expect to report top line data from the Tucatinib pivotal trial, called HER2CLIMB, later this year, and from the TV pivotal trial called innovaTV 204 in the first half of 2020.
Lastly, I want to highlight the first FDA approval from one of our technology licensees. Polivy or polatuzumab vedotin is an ADC developed by Genentech, that targets CD79b. It was approved more than two months ahead of the PDUFA date for patients with relapsed diffuse large B-cell lymphoma. Genentech is conducting several additional trials of Polivy including in frontline DLBCL.
Amongst several other collaborators that use our technology, GSK is advancing an ADC in late-stage development targeting BCMA. This ADC have PRIME and BTD designations, and GSK has stated that they are planning a regulatory submission in the second half of this year.
At this point, I'd like to introduce our Chief Commercial Officer, Robin Taylor, who joined Seattle Genetics in May. Robin, was most recently at AstraZeneca and before that he spent more than 17 years at Genentech. He has contributed to the global commercial development and strategic marketing of several successful oncology drugs. His skills are well suited to driving our global commercial presence including the planned launch of EV as well as other potential drugs emerging from our pipeline such as Tucatinib. We are pleased that he has joined the team. Robin?
Robin G. Taylor -- Chief Commercial Officer
Thank you, Clay. I am tremendously excited to have joined Seattle Genetics at this transformational time. I was drawn to the Company based on the strong leadership team, the innovative science, and the clear focus on patients as demonstrated by the continued investment in new indications for ADCETRIS and the exceptional late-stage pipeline. This is an important time for the commercial organization with the planned launch of EV and pivotal data anticipated for Tucatinib later this year.
Let me turn now to our second quarter results. ADCETRIS net sales in the US and Canada were $159 million in the second quarter, an increase of 30% compared to the same quarter in 2018. For the first half of 2019, ADCETRIS sales were $294 million, a growth rate of 35% for the first half of the year compared to the first half of 2018.
We attribute the growth in Q2 to three main drivers. First, we have observed continued strong uptake of ADCETRIS plus CHP in CD30-expressing PTCL following the US approval of this indication in November 2018. This is driven by the positive ECHELON-2 data, including the overall survival advantage that showed a 34% reduction in the risk of death compared to CHOP.
Second, we have seen continued growth of ADCETRIS in Stage III and IV frontline Hodgkin lymphoma. This reflects a positive reception to the three-year PFS data from Echelon-1 trial reported at ASCO. In addition, there has been an increase in patient engagement with growth in unique visitors to our online resources and downloads of the ask your doctor brochures. This encourages patients to ask their physicians about all available options for frontline treatment of Hodgkin lymphoma.
The update to the NCCN guidelines in April 2019 may also have contributed. And third, we have historically observed the strongest sequential growth between Q1 and Q2 for ADCETRIS, with continued, but more moderate growth in other quarters of the year.
Based on these historical patterns, we are maintaining our guidance of full year 2019 ADCETRIS net sales in the range of $610 million to $640 million.
Finally, we're actively preparing for the commercial launch of enfortumab vedotin with our partner Astellas. Sales force hiring is very close to complete, and we are beginning training activities to ensure that we are fully prepared for lunch. Having participated in multiple successful oncology drug launches over [Phonetic] my career, I have been pleased with the depth and rigor of the preparations of the commercial team at Seattle Genetics to date. I'm confident that we will be ready for the EV launch upon FDA approval.
Let me turn now to Todd to provide the finance update.
Todd E. Simpson -- Chief Financial Officer
Great. Thanks, Robin, and thanks to everyone for joining us on the call this afternoon.
So today, I'll summarize our financial results for the second quarter and year-to-date, as well as provide two updates to our financial outlook for the year. Total revenues were $218 million in the second quarter and $414 million for the year to date in 2019. This included record ADCETRIS net sales in the US and Canada of $159 million in the second quarter and $294 million for the first half of the year. Growth in 2019 primarily reflects the frontline label expansions in Hodgkin lymphoma and PTCL and the other dynamics that Robin described.
Royalty revenues in the second quarter of 2019 were $23 million compared to $21 million in the second quarter of last year. For the first half of 2019, royalty revenues were $39 million compared to $36 million in the first half of last year. We expect ADCETRIS royalties to increase throughout the year as Takeda sales grow, and as increasing sales trigger higher royalty rates. As a reminder, royalty revenues in 2018 included Takeda's portion of third-party royalty obligations paid on ADCETRIS, some of which expired in 2018. Therefore, despite the increases in sales by Takeda, royalty revenues grew at a lower rate, while cost of royalty revenues decreased.
Going forward, royalty revenues will also reflect amounts earned on net sales of collaborator ADCs such as Polivy, however, this did not contribute to second quarter results and is not included in our guidance.
Collaboration revenues which includes amounts earned under our ADCETRIS collaboration with Takeda and our ADC deals were $36 million in the second quarter and $81 million for the first half of 2019. This included the earned portion of $13 million in milestones achieved in the second quarter and $43 million in the first half of 2019, most notably by Genentech's recent approval of Polivy and Takeda's approvals of ADCETRIS in frontline Hodgkin lymphoma.
R&D expenses were $164 million in the second quarter and $322 million for the first half of 2019. The increases over 2018 primarily reflect investment across our pipeline primarily on our late-stage programs EV Tucatinib and TV.
SG&A expenses were $82 million in the second quarter and $163 million in the first half of 2019. These increases reflect commercial efforts to support ADCETRIS in the frontline indications as well as costs related to our late-stage pipeline programs.
We ended the second quarter with $376 million in cash and investments. This is in addition to $107 million in Immunomedics at the end of the second quarter. These shares are mark-to-market, which causes variability in our financial results and is not core to our business. These results or -- this resulted in a non-cash investment loss of $43 million for the second quarter, which was slightly higher than a similar non-cash gain in the first quarter.
Lastly, I want to highlight two updates to our 2019 financial guidance. First on revenues, given the recent milestones under the Takeda and Genentech deals, we are increasing our guidance for collaboration revenues to a range of $110 million to $125 million.
And secondly on SG&A expenses, in anticipation of the EV BLA submission announced this morning, we proceeded with hiring substantially all of the enfortumab vedotin US sales organization. As a result of this, we are increasing and narrowing our guidance for SG&A expenses to a range of $335 million to $360 million. Our other guidance remains unchanged.
Now I'll turn the call over to Roger.
Roger D. Dansey -- Chief Medical Officer
Thanks, Todd, and good afternoon, everyone. As Clay mentioned, the positive EV-201 pivotal trial results were featured in an oral session at ASCO in early June, and they also part of the subsequent best of ASCO program.
Among metastatic urothelial cancer patients, who received both the platinum regimen and the PD-1 or PD-L1 inhibitor, the confirmed response rate was 44% by blinded independent central review, including a 12% complete response rate.
For context, single agent chemotherapy which is the current standard of care in this setting shows limited activity with a response rate of approximately 10% with complete responses barely obtained. Responses in EV-201 were observed across all patient subgroups including those with liver metastases have particularly poor outcomes.
The median duration response was clinically meaningful at 7.6 months. EV was tolerable with a manageable safety profile. The most common treatment-related adverse events included fatigue, alopecia, decreased appetite, rash and peripheral neuropathy. Notably, the results are consistent with the earlier Phase 1 experience in the same heavily pre-treated patient population.
Based on these results, we and Astellas have submitted a BLA to the FDA seeking accelerated approval of EV.
As a reminder, we have breakthrough therapy designation in this patient population. The remarkable activity of EV monotherapy in patients with multiply treated metastatic urothelial cancer provide substantial development opportunities for EV to address a wide array of unmet medical needs.
Our EV development plan is focused in four key areas. First, enrollment is ongoing in the second cohort of the EV-201 trial of metastatic urothelial cancer patients, who perceived the PD-1 or PD-L1 treatment but are ineligible for cisplatin and/or platinum naive.
Second, the ongoing confirmatory randomized trial EV-301, which is intended to support global regulatory submission continues to enroll well.
Third, the ongoing EV-103 trial, which combines EV with pembrolizumab and/or platinum chemotherapy in the first-line metastatic setting. This is the precursor to a frontline randomized trial, and we expect to report data from the EV plus pembrolizumab cohort later this year. And fourth, trials are being planned in earlier stages of urothelial cancer such as muscle invasive bladder cancer as well as other Nectin-4 expressing tumors.
I'll move on now to ADCETRIS, which was the subject of numerous presentations at ASCO, as well as the European Hematology Association and the International Conference on the -- lymphoma meetings. Across these three Congresses, we reported on several important data sets. First, we showed that with an extended follow-up in the ECHELON -1 trial, the PFS benefit for ADCETRIS plus AVD determined by investigators was maintained. The three-year PFS was 83.1% compared to 76% in the AVD arm, a difference of 7.1%.
Importantly, consistent improvement in PFS was observed among patients treated with the ADCETRIS regimen across the majority of pre-specified subgroups, including disease stage in prognostic score. Second, analysis of several trials including Echelon-2 showed responses in non-Hodgkin lymphoma patients across all levels of CD-30 expression. These data support the notion that there may be no specific expression level required for efficacy.
And third multiple abstract highlighting the activity of ADCETRIS in combination with the nivolumab including in Hodgkin lymphoma and primary mediastinal B-cell lymphoma.
Importantly, ADCETRIS plus nivolumab was recently added to NCCN treatment guidelines for second-line Hodgkin lymphoma.
Lastly, we are now initiating additional trials of ADCETRIS that may result in label expansion, two of which I've mentioned today. One trial will evaluate retreatment with ADCETRIS in Hodgkin and T-cell lymphoma patients, who progress after a prior response, including in patients, who received ADCETRIS in the first-line setting.
Encouraging data with retreatment in the relapse refractory setting have been previously published.
We are also initiating a trial of ADCETRIS in Hodgkin lymphoma and PTCL patients, who are unfit for combination chemotherapy either due to old age or comorbidities. This is an area of high unmet need. We believe the generating data for labeled indication is important for physicians and patients. We also expect to initiate additional label enabling and practice-informing trial, and we'll keep you posted as our plans progress.
Next I'd like to briefly highlight the status of our late-stage programs tucatinib and tisotumab vedotin. Both of which are in registration trial.
Tucatinib is a potentially best in class oral tyrosine kinase inhibitor that targets HER2. We are conducting a randomized pivotal trial, called HER2CLIMB in heavily pre-treated HER2-positive metastatic breast cancer, including patients with brain metastases.
Patients in this setting have a poor outcome with standard of care treatments. HER2CLIMB enrollment is complete and we continue to expect to report the top line results for the primary endpoint of PFS later this year.
We are also initiating this year a Phase 3 randomized trial of tucatinib in combination with TDM-1 compared to TDM-1 alone in the second-line metastatic HER2 positive breast cancer setting.
The primary endpoint of PFS was a key secondary endpoint of OS. With this trial, we aim to show improved outcomes combining tucatinib with a HER2 ADC, which is a well-established standard of care in earlier lines of breast cancer. Data from a published Phase 1 trial support evaluating this combination. Tisotumab Vedotin or TV is an ADC targeting tissue factor that we are developing in partnership with Genmab. We are conducting a pivotal Phase 2 single-arm single-agent trial in women with recurrent or metastatic cervical cancer, where there is no standard of care and outcomes are poor. The primary endpoint of the trial is confirmed objective response, enrollment is complete, and we are following patients for a response assessment and importantly durability of response.
We estimate reporting top line data in the first half of 2020, if positive, the trial could support regulatory submissions and the FDA's accelerated approval mechanism. Now, I'll turn the call over to Clay.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Thanks, Roger. We've accomplished much in the first half of 2019. And the second half of the year is poised for many additional activities that are important to our goal of bringing drugs to patients in need. These include: first, continuing to establish ADCETRIS as the standard of care at frontline Hodgkin lymphoma and frontline PTCL and initiate clinical trials to further expand the ADCETRIS label.
Second, work with FDA on our EV submission in collaboration with Astellas, report initial results from the first line EV-103 trial and expand the EV development program with several new trials.
And third, report top line data from the Tucatinib pivotal trial HER2CLIMB later in 2019 and advanced the TV pivotal trial in cervical cancer toward top line data in the first half of next year.
I'm excited by the progress we're making with ADCETRIS, enfortumab vedotin and the rest of our product pipeline. We'll keep you updated on our progress.
At this point, we'll open the line for Q&A. Operator, please open the call for questions.
Questions and Answers:
Operator
Thank you. [Operator Instructions] We'll take our first question from Kennen MacKay with RBC Capital Markets. Please go ahead.
Kennen MacKay -- RBC Capital Markets -- Analyst
Hi, thanks for taking the question. For the team, first off, big congrats on the quarter. I was just wondering, if you could help us understand the decision not to increase guidance here. I ask because given the recent price hike in ADCETRIS, it seems like it will squarely be within your guidance, with zero growth and with only 3% sequential quarter-over-quarter growth in Q3 and Q4 you'll hit the upper end of guidance, which seems quite doable. Is there anything we should be reading into here.
And also on that topic, I was just wondering if you could help us understand the ADCETRIS inventory in Q2. Could there may be a week or two of stocking here given the June 28, price hike? Thank you.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Thanks, Kennen, and thanks for the questions. So when we think about ADCETRIS, it's a really important brand, it's growing as a brand in US, growing international, and we're pleased with what we're seeing. We reiterated the guidance, and please note, we're giving annual guidance, we're not giving quarterly guidance that we did while we were in the middle of getting frontline approvals. And so we reiterated $610 million to $640 million, which is 30% over 2018. And so it's a strong guidance, and we're trying to be as accurate as we can. We have a range there. And we have good connection with docs and our three-year PFS data with E1 was particularly important.
And E2 data was spectacular, you know that, not only with PFS but with OS. But Q2 is typically strong. Now looking out into the future, is really hard to know exactly what we're going to get. It's hard work out there, we're continuing to displace decades old standard of care that are entrenched in the marketplace, and we're working harder. We like what we see a lot, we still feel that our products are growing and that's -- our guidance indicates that. And I would just say to stay tuned and we're out there at full force, our commercial team is doing well, and we're really connecting with docs.
Kennen MacKay -- RBC Capital Markets -- Analyst
Thanks. [Speech Overlap]
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Your second part...
Kennen MacKay -- RBC Capital Markets -- Analyst
Go ahead.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Your second question, Kennen, we have really no evidence that there is really any stocking as you call at the end of the inventory, we really don't see that. We know that there are some big cancer centers that will -- more vials in the small cancer centers, because they treat more patients, but that's not really stocking. So we don't see any evidence for stocking of ADCETRIS. We deliver in real time, people order it, they get it quickly. And so we feel really good about where we are, and we just don't see sites accumulating inventory.
Todd E. Simpson -- Chief Financial Officer
And Kennen, this is Todd, I want to add just one more comment, you talked about the price increase, we did have a 3.9% price increase in July. But keep in mind that we only see about half of that come through our net sales, because of the discounting in the gross to net, particularly around the PHS share of our business, which is pretty significant.
Kennen MacKay -- RBC Capital Markets -- Analyst
Thanks, Todd, that's really quite helpful context, especially given the current political environment, and I think important to remember. Maybe just one follow-up for Clay and maybe also for Robin. Just wondering, if you can help us understand the changes that you've been making with the ADCETRIS sales force here. It seems like tracking the website, there has been quite a bit of hiring going on here. Is that also sort of playing into the increased ADCETRIS sales that we saw in Q2 and is that responsible for the SG&A guidance increase or is that more of the EV sales force? Thanks and congrats again.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
First of all, thanks for mentioning we had a good quarter. We're very proud of that. It is really more related to the last thing you said, EV sales force. We thought it would be important to have some of our sales people from ADCETRIS go to the EV program for continuity and connection. And so we replaced some of the people on the ADCETRIS sales force. Robin, do you want to talk about the folks that we're getting, the type of people that are looking to come work with us both on ADCETRIS and EV?
Robin G. Taylor -- Chief Commercial Officer
Yeah. No, what I'd say is that, we are seeing very strong interest in Seattle Genetics. The hiring on the EV sales force as I mentioned is almost fully complete, and we had a lot of interest in those roles. We did have a few folks come over from the ADCETRIS sales force over to EV. And of course, you -- what you saw online with some of the backfills for those positions, but I would say that we've got a really high performance group with great depth of oncology experience for the EV sales force.
Peggy Pinkston -- Vice President, Investor Relations
Operator, we'll take our next question.
Operator
Our next question is from Cory Kasimov with JPMorgan.
Matthew Thomas Holt -- JPMorgan -- Analyst
Hi, guys. Thanks for taking my question. This is Matthew on for Cory. So for my first question, I'm trying to understand the potential impact of the international pricing index proposal on ADCETRIS pricing? And I was wondering if you could provide any qualitative or quantitative commentary in that regard should [Phonetic] this policy be implemented?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Thanks, Matt. Look, we're aware of the issues and closely track them, it certainly dynamic, there's changes literally daily or frequently. We're paying attention like any biotech or pharma company is. Ultimately, we believe fully that innovative medicines that provide meaningful benefits will continue to be valued by patients, physicians and payers.
ADCETRIS is a first-in-class drug. EV, another drug that we believe will be first-in-class, and these are drugs that really have an impact on patients, and they are valuable. And so we're watching. I'm not sure what will happen exactly, I think you're not sure as it -- as we are.
Matthew Thomas Holt -- JPMorgan -- Analyst
Got it, thanks. And then, my second question is on tucatinib in the initial data expected this year for the HER2CLIMB. I'm just curious what you're hearing from KOLs [Phonetic] in terms of what PSF value or hazard ratio would be clinically meaningful in the context of all the other available treatments in this space?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Sure. We're really excited about HER2CLIMB and coming forward with data later this year. Roger, do you want to go talk a little bit about the context of what's out there in the world.
Roger D. Dansey -- Chief Medical Officer
Sure. Yeah, it's a good question. So the HER2CLIMB trial has some unique aspects to it, particularly, the patient population that has been enrolled with a very high frequency of patients with brain metastases. So it is an extremely high unmet need population. But the trial design is the triplet versus the doublet of tucatinib added on to Trastuzumab and capecitabine, we think is a very thoughtful design that may result in positive outcomes.
In terms of what is a meaningful delta, I think it's very hard without seeing the data to make any specific comments on that. Again, there isn't really historical control that you can absolutely map to. And the unmet need is very high. So everything is a relative decision. And I think that's about where we can go at this point, but we're excited as Clay said, the trial enrolled well. We're hoping to get the read out by the end of the year, and of course we'll note that time.
Matthew Thomas Holt -- JPMorgan -- Analyst
Great. Thanks for taking my questions and congrats on the quarter.
Operator
We'll take our next question from Michael Schmidt with Guggenheim.
Michael Schmidt -- Guggenheim -- Analyst
Hey, thanks for taking my question and congrats on the good quarter for me as well. I had a question again on the ADCETRIS sales number for this quarter. It sounds like -- and correct me if I'm wrong, but it sounds like much of the ADCETRIS sales growth was driven by increased use in PTCL. And I was just wondering, if you could comment a little bit more about on what are you seeing in terms of market dynamics in PTCL right now for example, what market share do you have in frontline treatment at the moment and are those rates comparable in the different subtypes of TCL?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Thank you for your questions, Michael. So first of all, as we said in the prepared remarks, we think that as we track this, our growth in revenue was attributed to both the E2 regimen, which is in PTCL growth as well as in the E1. Now in the E2, we're not going to report the different subtypes. We can tell you that they're being used in all of the subtypes as far as what we can find, but we're not going to report specifics about that.
We also don't report the specific market share. What we can say is that we predicted that it would take a number of quarters to get bigger and bigger market share, because this was a regimen that we were displacing CHOP specifically in PTCL that was around for almost three and half decades. So this is -- it's not that easy to displace these entrenched therapies. Now the good news with the E2 regimen is we had not only PFS data but OS data.
And so now let's switch to E1 regimen for frontline Hodgkin lymphoma, and there, as you know, we experienced little headwinds in the past, we had to -- we got a lot of early adopters and then we had some -- docs have said look, I know how to treat frontline Hodgkin lymphoma. I've been doing it for decades well, and you're showing us data that's only of limited duration of follow-up. We'd like to see some more.
So this year, for instance, we have shown now 37 months of follow-up data, and the data actually improved with time. So now, if you just look at PFS, good old fashion PFS and you look at 37 months, we are now 7.1% better in PFS. And that's important, because while you can't yet call these cures, these are a long-term disease survival and once you get out past five years or the definition of a cure from oncologists, we can start calling it that, but it is likely that a lot of these patients will go that long and hopefully within the not-too-distant future, we can really look at what could be a cure rate increase in Hodgkin lymphoma.
And going from the two-year data that we produced, when we first got approval to the 37-month data that came out with PFS. I think that caught a lot of doctors attention. And so, they looked at this, they saw it and they were more comforted by that, because we don't yet have OS, which in E1 in the E1 regimen in frontline Hodgkin lymphoma was not contemplated to have yet.
So there was nothing wrong, it just takes a while. With E2 and PTCL, the standard of care wasn't nearly as good as it was with E1, the Hodgkin regimen. So I really understand what doctors are saying, I understand that they wanted to see a little bit more aging of our data and the data improved with age.
So I think that's a big deal too.
Michael Schmidt -- Guggenheim -- Analyst
Okay. Thanks. And then I had a pipeline question regarding tisotumab vedotin. I know the initial indications obviously cervical cancer, but I was just wondering, when we might learn about the potential of that agent in other solid tumors?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Yeah. We're definitely looking at cervical cancer. Roger, can you touch on a little bit of generally what we're looking at with TV?
Roger D. Dansey -- Chief Medical Officer
Sure. So the program is configured to evaluate cervical cancer, as you -- as you mentioned in the pivotal trial with data readout hopefully in early 2020. The -- but we have other efforts going on. So we in fact have a basket trial, which is looking at other tumors that express tissue factor with TV potentially has a role and that's an ongoing trial at the moment, we haven't read out data yet, but obviously when we do, we'll present that.
We also have an effort going on specifically in ovarian cancer. So we have a number of different trials outside of cervical cancer exploring the potential for TV in other diseases.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
And what I would add also is we actively speak with our partners, Genmab, I'm often about trying to maximize TV. So just so that you know, we're excited about the product and working hard on it.
Todd E. Simpson -- Chief Financial Officer
And maybe one piece to add is we in fact do have the beginnings of a combination trial with TV and pembrolizumab as well. So that's up and running.
Michael Schmidt -- Guggenheim -- Analyst
All right. Thanks for taking my question.
Operator
We'll take our next question from Andrew Berens with SVB Leerink. Please go ahead.
Andrew Berens -- SVB Leerink -- Analyst
Thanks. I appreciate it. And congrats on the quarter guys. I also had two questions, one on PTCL, given the prepared comments, and I know you said, you wouldn't talk about different subgroups, but is this a disease or opportunity that we should think of as a prevalent opportunity? Or is it really new patients that are driving what you're seeing -- is there a possibility patients are going to get ADCETRIS through multiple lines of therapy when they relapse, it's more of a prevalent disease?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
So on PTCL, we're out there talking about is the data on for incident patients, and so that's what we're looking at. Newly diagnosed incident patients. So I don't -- we don't have a lot of data on prevalent. I mean, we still have approval to treat relapse patients, and that's one of our labels especially in ALCL and some other in CTCL. But we are really focused on the newly diagnosed patients and working with our commercial team and doctors to get newly diagnosed patients ADCETRIS CHP, because the data is so clearly positive and not just on PFS, but on OS and you look at the Kaplan-Meier curves and you'd be hard pressed to find bigger white space between Kaplan-Meier curves and clinical trials.
This is a really positive dataset that I feel that patients and doctors should really look at this before jumping into a different therapy, because they can really be benefited.
Andrew Berens -- SVB Leerink -- Analyst
Okay. And then one of the things we've heard from some of the community docs is that buying and billing the patient is a real concern for some of the docs with private practices. I was wondering, if you guys have heard that? And if so, what efforts could be done to kind of waylay some of those fears and financial concerns to the clinicians?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
We haven't really heard much of that at all, I have to say. As far as physicians getting reimbursement in PTCL, which is I think what you're looking at, we really have not heard that there is issues out there. We think that our market share is growing in this space as we predicted. We think it was going to take some time to grow and entrenched -- previously entrenched therapy, and it's -- we're pretty much on track for what we thought the growth rate would be on a quarter-to-quarter basis with the E2 regimen in PTCL. So I don't view what you said is this buying and billing thing as an issue.
Andrew Berens -- SVB Leerink -- Analyst
[Speech Overlap] It wasn't limited to E2, I was talking about ADCETRIS and really Hodgkin lymphoma. I think is where these comments originated?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
We -- I have to say we just aren't hearing it in the way you are, so I don't know where this information comes. I'll certainly explore this with our commercial team. But I don't think we are seeing. Todd, do you have any comments?
Todd E. Simpson -- Chief Financial Officer
Well, I'm just going to say, the other thing to keep in mind is we have an incredibly efficient model, where a site can order drug today and they'll have it tomorrow, so there isn't this need to buy ADCETRIS and hold it, because of a concern or a fear that it's going to take weeks and weeks and weeks for your drug to show up, we're literally overnight shipping.
Andrew Berens -- SVB Leerink -- Analyst
Okay. Appreciate it. Congrats again.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Thanks.
Operator
Well take our next question from Salveen Richter with Goldman Sachs.
Maryana Breitman -- Goldman Sachs -- Analyst
Yes. Hi, thank you for taking our questions. This is Maryana Breitman for Salveen. We had a couple. One, we were wondering with the NCCN updates for Hodgkin lymphoma. Do you have any color on changes to prescriber activity due to updated guidelines? And we were also wondering about tucatinib opportunity in metastatic breast cancer, especially in patients with brain metastasis, how are you thinking about that opportunity? How are you thinking about going into that market? Thank you.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Thank you for the two questions. Concerning the NCCN that you asked, we think that certainly we'd like the new wording with NCCN, but it's not really -- it's hard to know what that impact will be or what that impact was. We think that the three-year PFS data that we showed at ASCO, and we think that the response from doctors, we think is the most valuable thing that we have, because we could tell that they look at that closely.
With NCCN that also connects with how pathways are, and how doctors prescribe it, and those are things that evolve slowly. Pathways don't meet very often at all, and that -- it takes its own life, and we're not really part of that, but the data and the way doctors respond to this age data, that's improved and really gives benefit to the patient. That's really what we think is the most important thing for the increased E1 regimen sales that we are seeing.
And you asked about tucatinib and the opportunity. Tucatinib is something that is a drug that we think could be a best-in-class drug, it's clearly not the first of the HER2 TKIs out there, there are a few of them. So it's a validated pathway, but our goal is to really raise the bar and get to that next level with helping patients with a very potent drug, but one that doesn't buying the EGF receptor and cause all that toxicity that you would have with some of the other HER2 TKIs.
As far as the specific benefit and talking about the size of the population, it's a little early for us to do that. We're still doing, working on our pivotal trial and it's an event-driven trial, we guided to later this year more data to come out. And then let's just see what the data -- we're happy to give data and there is plenty of time in the future to talk about the specific opportunity. And I really think it depends on the data. We have -- the primary endpoint is all of the patients put together, and then the secondary endpoint include importantly brain metastasis. So this is a unique trial design with a couple of different data sets that will result from the data.
And I think that looking at the opportunity for this really depend on whether this works on all patients, including pembrolizumab [Phonetic] patients. What works most on one or another set of patients, then we could adequately start addressing your question. But until then, we will hold off on it and are excited to address this question in the -- hopefully not too distant future, later this year.
Maryana Breitman -- Goldman Sachs -- Analyst
Thank you.
Operator
We'll take our next question is from Gena Wang with Barclays.
Gena Wang -- Barclays -- Analyst
Thank you very much for taking my questions, and also follow up with CapEx. Maybe I will ask. Wondering if you can remind us the event rates of PFS and also if the trial designs do design to detect 50% PFS improvement and another related questions regarding the bring mats [Phonetic] patient. What is the percentage of patients you plan to enroll?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Okay. So I got your three points there. So, the event range from PFS, we have not reported and that's something that we keep confidential. The amount to detect a 50% improvement, also is internal information and that's not something we will be reporting. We have said that we are planning to enroll. And I know it has. This is true, because all the patients are enrolled that we have roughly half the patients, have pre-existing measurable brain mats. And that mix has one of the uniqueness of this trial, we're really addressing a major unmet medical need.
Gena Wang -- Barclays -- Analyst
Great. And I have one quick follow-up regarding ADCETRIS quarter revenue. So you mentioned that the majority the growth is driven by frontline PTCL, is it fair to say out of $24 million quarter-over-quarter growth close to $20 million will be from frontline PTCL? And then should we expect the future growth mainly driven by the PTCL revenue?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
I think our prepared remarks said that we're really pleased with the growth in frontline PTCL. But we also have growth in frontline Hodgkin lymphoma. We did not look at the breaking that apart nor do we plan on breaking apart. I think looking forward, we continue to see that we are getting increased market penetration and that goes for PTCL, which was approved like almost a year later than Hodgkin lymphoma, maybe it was early in 2018 to late in 2018. So maybe a little less than a year. But so frontline Hodgkin lymphoma has been out there a little longer and its growth rate is probably a little slower at this point just because it's out there a little longer than frontline PTCL, but both are growing, and we're really pleased with what we're hearing from docs out there.
And I know we had a bunch of questions on guidance, it's hard to really give guidance on this. We're in uncharted territory in frontline Hodgkin, in frontline PTCL and the data we have is great. The age data is great, doctors are rallying to this, and we're out there trying to do the best we can by patients. And what I would say is, stay tuned on this, and we'll provide you with whatever data and follow up that we can when it's appropriate.
Gena Wang -- Barclays -- Analyst
Thank you very much.
Operator
We'll take our next question from Tazeen Ahmad with Bank of America.
Tazeen Ahmad -- Bank of America -- Analyst
Hi, good afternoon, and thanks for taking my questions. Clay, I just wanted to get a sense on the sales force that Todd had talked about, you guys have hired, how big of a sales force do you anticipate you'll need for EV in the US? And do you plan on hiring all the sales people at once?
And then secondly for Tucatinib, as that data that reads out, I guess what kind of data should we expect at the top line, what level of efficacy would you consider to be clinically meaningful? And how important is it for you to show a better safety profile than currently approved treatments vis-a-vis especially diarrhea rates. Thanks.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
So let's those are two different questions. Let's start talking about the sales force for EV and I'd like to turn it over to Robin to kind of explain our thoughts here. Robin?
Robin G. Taylor -- Chief Commercial Officer
Sure. Thanks, Clay. So, we worked really closely with Astellas to size the sales force to ensure that we have a broad reach to healthcare practitioners, who treat metastatic bladder cancer. We will have with Astellas an equal number of reps in the field. We will utilize our existing commercial infrastructure for activities managed markets and distribution, but we will also have some brand specific roles, such as the dedicated EV marketing team and that's really sort of where we stand, which is equal partnership with Astellas here.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
So the second question is on tucatinib and talking about efficacy and the safety profile. And for sure the reason we acquired Cascadian to largely get this drug as that we saw, a really exciting drug from a safety standpoint because it didn't bind to EGF receptor. And a really exciting drug from an efficacy standpoint in single arm studies. I will repeat that, single arm studies. And the [Indecipherable] us to perform in a randomized study in order to get registration.
So Roger, can you talk about some of what -- give context to where we are?
Roger D. Dansey -- Chief Medical Officer
Sure. So as you know HER2CLIMB is fully enrolled. Just to reiterate some of the points.. This is a high unmet need population with a substantial proportion of patients with brain metastases, there is really no historical precedent that we can actually define what the potential for the control arm would be? Based on the profile of Tucatinib, it's highly selective. So in addition it's lack of inhibition of EGFR, that is a potential best-in-class molecule, both characteristics are key to both its efficacy and its safety and the tolerability. So as Clay said, the data has been generated with single-arm trials obviously very encouraging. Including with Tucatinib and TVM-1, which is why we've proceeded to start another Phase 3 trial, but until we see the data it's really -- we can't really make any statements about what the potential treatment effect would look like.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
What I can say to the -- one thing I can add, is that, you've seen a lot of data sets come out from other trials. And when you look at PFS in this type of population, it's always measured in terms of months. So the first thing I can tell you from that whenever I see that in my decades of doing cancer work, it says to me loudly unmet medical need.
So we're in an area, where patients need something, they don't just walk away saying, Yay! There is drug, extra drug, why I'm cured, that's not what it is. We're talking a lot of these patients, they get a drug and response were measured in month.
So we have a really big important area to go into. And when you have brain metastasis, which literally half the patients get, there is not anything really out there. So it's a grim prognosis and we're trying to really do a good job and help patients and work on this drug. So data, it's coming soon sometime this year. We are incredibly excited, and I'll remind you we really loved all the data from single-arm trials. We just thought they were outstanding, and this was the right drug. But we do not yet have the randomized data and FDA rightly wants in this setting, with all the other drugs, they want to see randomized data, and we're up to that challenge and we're looking forward to reporting it.
Tazeen Ahmad -- Bank of America -- Analyst
Okay. And then just on safety Clay to wrap it up. How are you thinking about diarrhea rates, do you think that's an important differentiator in this population? Or is it -- as you said, when you have PFS in the months that this is a high unmet medical need area and any improvement is a good improvement?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
I would go back to our early data on this drug, because obviously, we have not reported data from this pivotal trial. And early data shows a dramatic difference in any GI toxicity. You just don't bind EGF receptor. I'll remind you that both the first two HER2 tyrosine kinase inhibitors that were approved both bind to HER2 and inhibit the tyrosine kinase. But both of them bind to EGF receptor. And I don't believe that they were screened to not bind to EGF receptor. I think they were screened specifically for the HER2 TKI activity, whereas tucatinib with screened with not only carry something potent for HER2 TKI, but screened that it didn't bind to EGF receptor. So this is what's unique about this drug. And if you look at the safety profile for literally hundreds of patients that were treated in single-arm trials, it's from a standpoint of comparison to the others that are out there, it's pretty dramatically different.
So I think that -- I felt very confident about the safety profile, where we just didn't know is in a randomized trial versus active competitor, how would you -- how would it come out. And Roger, do you have -- so do you want to add anything to that?
Roger D. Dansey -- Chief Medical Officer
No, I do. So I think just as a case in point around the safety profile. I just remind you that HER2CLIMB is a blinded, is a placebo-controlled trial. And in general, placebo-controlled trials can only be done, if you are unable to tell which drug you're on placebo or the active agents. So that's an important point to remember.
And secondly, in a disease like breast cancer, which is a chronic disease, tolerability is key. If you're taking a drug twice a day and you can't take it for too long, it's not just, is it a safety issue, it can potentially feed into efficacy as well. So I think those two points are worthy of some consideration.
Tazeen Ahmad -- Bank of America -- Analyst
Okay. Thanks for that color. I appreciate it.
Operator
We'll take our next question from Steven Wiley with Stifel.
Steven Wiley -- Stifel -- Analyst
Yeah. Thanks for taking the question and congrats on a really good quarter. Just a quick question on PTCL and then one on tucatinib. So just curious to what extent screening for CD30 expression may or may not represent a rate-limiting step for ADCETRIS right now and PTCL, either from just the utilization of reimbursement perspective. And I guess how does the recent data demonstrating that the ADCETRIS benefit is agnostic the CD30 expression potentially change that?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
So -- and certainly at ASCO, you saw the presentation from the docs that said that they had responses whether patients were CD30 high or CD30 low or even CD30 without even be able to through histology, be able to see it. Now when you -- historically we've looked at all these pensions and you could look them would histology and histology, has a very big gray area background noise.
So when you get down to lower levels of CD30, it's impossible to know whether it's positive or negative. You could just say histology a negative, but that doesn't mean negative. And when you look at molecularly and it's -- we are hard pressed to find a lymphoma that's a T-cell lymphoma that CD30 negative when you look at it molecularly and also CD30 is an activation antigen.
And it kind of goes up and down, and when you look at different nodules you can even find different amounts of CD30 within the same patient. So it is a very complicated scenario, where the prediction would be that all patients respond, because CD30 is there on all and can go up and down and in fact that is exactly what the doctor showed in their presentation at ASCO.
So I think to the utility of it in different subtypes, and based on all our data and everything we know, I think we have a really good case there, the doctors should use this and it could benefit patients. So I certainly don't think that hurts and you had a second question on Tucatinib?
Steven Wiley -- Stifel -- Analyst
Yeah. Just a quick follow-up on that, then I guess if there were a mechanism by which you could remove that CD30 expression requirement from the label. Would that change the narrative of uptake, do you think?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
What our requirement on there is it's CD -- I mean, in Hodgkin lymphoma is out there at all. And in T-cell lymphoma, it's just as CD30 positive. So it's not like I mean, it could be a trace of it and be positive. So we don't find it as an impediment at all quite frankly.
Steven Wiley -- Stifel -- Analyst
Okay. And then just for clarification on Tucatinib. I know that you're talking about in other study here in combination with TDM-1 in the second line. Just want to clarify if the initiation of that trial is contingent upon HER2CLIMB data?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Roger, do you want to comment on that?
Roger D. Dansey -- Chief Medical Officer
No, it's not. It's the, we believe it's the right time, tucatinib all the properties we've described, this is again a validated pathway and we've generated the Phase 1 data, which supports the combination, and we think it's the right time to proceed in that direction.
Steven Wiley -- Stifel -- Analyst
Great. Thanks for taking the questions.
Operator
We'll take our next question from Shanshan Xu with Berenberg Capital Markets. Please go ahead.
Shanshan Xu -- Berenberg Capital Markets -- Analyst
Thank you for squeezing in. I have one question for Roger. If the upcoming readout of HER2CLIMB is positive, how should we think about expanding indications beyond breast cancer for tucatinib? And I have one follow-up for EV.
Roger D. Dansey -- Chief Medical Officer
Sure. Thanks for the question. So as we are -- as we are now, we have tucatinib being incorporated into us by looking at neoadjuvant applications, you see HER2CLIMB in the multiple-treated population. We're now moving into second line metastatic breast cancer. We have an investigator-initiated trial called [Indecipherable], which have data combining tucatinib together with Herceptin in a third line plus colorectal cancer population. We hope to have that data out later this year.
I think we, again if tucatinib turns out to be the potential best-in-class realizes it's potential than anywhere that the TKI can have a role in the HER2 expressing tumor is where we want to go. So that includes CRC, it includes other stages of breast cancer potentially gastric cancer. There are other cancers that our HER2 expressing that could be of interest as well.
So I think if we have a real molecule here we will flesh out the development plan as appropriately fully as we can.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
I think it's a good proposition for any breast cancer oncologists. If our data turns out where we think it could with HER2CLIMB to have a tablet that's well tolerated and really works. I think would be this would be a really important drug and we'll get a lot of use in and we'll be in many different lines and of therapy in breast cancer and outside of it. So [Indecipherable] you had an EV question?
Shanshan Xu -- Berenberg Capital Markets -- Analyst
Yeah, I absolutely agree with your commentary on tucatinib. One follow-up on EV so we witnessed a very impressive data of screens Tier 1 which is a third line trial in EV2, while the medium OS is only two to three months shorter than the standard of care in frontline urothelial carcinoma. So I believe this is actually in everyone's interest to move EV into the pivotal trial of the frontline urothelial carcinoma. In the past, at ASCO we saw that it took CALGB 90601 almost five years to achieve a full enrollment. So, Roger and Clay, what are potential drivers to accelerate enrollment for frontline urothelial carcinoma trial for EV? Thanks.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
First of all, I did want to make a commentary before getting to your question on EV. We have not had a single question from any analyst or comments from any analysts to the speed with which we submitted EV. We busted our back and submitted this much faster. We guided that it will be submitted sometime this year and it's July and we submitted it in the middle of July. So this is months ahead of where most of you had in your models. I think most of you had some time in the middle of fall in your models. So, I would like the analysts to notice that, which I think will translate into getting this product on the market faster, and it's an important product, and doctors are screaming for. So, this is part and parcel into we're trying to make a difference in patients' lives and we, together with Astellas, worked like morning, noon to night on getting this to a submission because it's important. Okay? This isn't just a Wall Street thing. It's a patient thing. And so, I want everyone to notice how fast we worked on this.
Secondly, we are excited about the potential of EV in frontline, and there is a lot of different approaches. Roger, do you want to give context to that?
Roger D. Dansey -- Chief Medical Officer
Sure. So, if you look -- you can look back into the EV-103 trial and you can understand what our potential choices are. It's EV is the backbone with a PD-1 inhibitor plus-minus chemotherapy. Those are the types of choices that we're facing. I must say, I agree with you, there is a frontline metastatic urothelial cancer is still a high unmet need. I think that personally if we come up with a very thoughtful considered acceptable trial design, the excitement around the combination of EV with other drugs once we have that data presented, if it supports that will drive a lot of the enrollment. Bladder cancer has changed because all of the immuno therapies have come in and there is a lot of interest now in bladder cancer, docs are focused on moving trials ahead, whereas in past times where there was really just chemotherapy versus chemotherapy, not an interesting question, not an exciting question to answer. That's possibly why the CALGB trial was so slow. I would hope that we would be way quicker than anything like that.
Peggy Pinkston -- Vice President, Investor Relations
Operator, we'll take our next question, please.
Operator
We'll take our next question from Andy Hsieh with William Blair. Please go ahead.
Andy Hsieh -- William Blair -- Analyst
Great. Thanks for taking my questions and congratulations to the Seattle Genetics team. It's nice to see that inflection point commercially. So I have two questions. One is probably for Roger. So, could you remind us the specificity and potency of tucatinib, specifically pertaining to HER2 mutants? And if that is potential differentiator versus other oral TKIs?
Roger D. Dansey -- Chief Medical Officer
Yeah. Thanks for the question, Andy. We are interested in the mutant population, we haven't studied it. So that's something that we need to potentially move forward on. Tucatinib is very similar to neratinib in terms of its HER2 selectivity and potency. They are very close. So, the ability to inhibit the target with tucatinib is as good as any other -- as sort of the most potent inhibitor currently available, which is neratinib.
Again, coming back to the HER2 mutants, we are interested. Again, anywhere there is a potential role [Phonetic] for tucatinib, we need to signal sign. So that's for our future effort.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Andy, we believe that -- and this is based on data, like, with Herceptin, for instance, but -- and HER2 TKIs. When you keep pressure on a tumor in a patient, the patient does better, and that's what you see with other agents. And one of the things about these HER2 TKIs is if they're really toxic, you can't see pressure on the tumor. You have to discontinue and not -- enable that to get therapy. So it's not -- as Roger said before, it's not just a safety issue, it also relates to efficacy and that's what we saw when we did a lot of diligence on this. We saw that this could change the paradigm and raise the bar and allow for a TKI to keep pressure on the tumor for a substantive period of time. And that's really what's important.
Andy Hsieh -- William Blair -- Analyst
Okay. Thanks for that. Just as a follow-up, and this pertains to EV. So most of the time when you go from early Phase 1b to Phase 3 of any pivotal studies you take some sort of response rate PFS duration, penalty. Just curious, have you identified kind of any factors that contributes to just the impressive consistency across these -- the early stage [Indecipherable] analysis and the 201 top line results?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
I will tell you that the clinical team at Seattle Genetics and the certainly has been the case prior to Roger joining, but even emphasized more with Roger is, we don't want to get too over excited about Phase 1 data unless we do a blinded third-party reviews and things like that. So we want to look at, not just responses, we look at confirmed responses. So, when you see Seattle Genetics data from Phase 1 and it says confirm responses, the chance that that will repeat in a bigger study is pretty high, because these have already been stared at, where I see a lot of times companies put our data and there are unconfirmed responses, and then you see the later and it's a much smaller response rate and much less duration, and all these things and that's because they weren't as fastidious as we are.
We're more interested at this point, or at all points in Seattle Gen's history, we've been interested in actually making substantive improvement in patients' lives with unmet medical needs and not just getting a little bit of hype on some drug. So we want the real data out there and I think that's what contributes to our your early stage data matching pretty closely to the pivotal because we do it the same way with the same rigor.
Roger, any...
Roger D. Dansey -- Chief Medical Officer
Yeah. Two other comments. So firstly, good drugs really work, and when they really work, they really work again and again. That's certainly one part of this. The other is just bear in mind, the sample sizes are not 10 patients or 20 patients. We're talking 100 plus. And so, the variability around those constant integrals is much smaller than a very small sample size, where you can potentially get yourself misled. So, it's great that the data is reproducible. You're right, many times that Phase 1 experience, as Clay described, degrades overtime and that's obviously not something that anyone likes to see, but certainly with EV, we have not have that experience. And so, it does bode well for the future of the drug.
Andy Hsieh -- William Blair -- Analyst
Thanks for answering all my questions. And super helpful context.
Operator
We'll take our final question from Silvan Tuerkcan with Oppenheimer. Please go ahead.
Silvan Tuerkcan -- Oppenheimer & Co. -- Analyst
Thank you for taking my question and congrats on the quarter and the submission. Could you please give us a little bit more color on your pre-launch activities for EV outside of the sales force, such as maybe interactions with payers you have? And also, is there any strategy that leaps out at you in terms of how you can roll this out quickly in terms of what centers to target?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
First of all, I will thank you for the question. I mean, I -- we are putting in a very large amount of effort on our pre-launch activities for EV, and it's across the board in lots of different areas. I mean, this is -- this drives the real deal. So we're not going in for a soft launch. We're going in for the full launch, no soft launch here in EV for sure.
Robin, you want to put this in context?
Robin G. Taylor -- Chief Commercial Officer
Yeah, certainly, Clay. Like any new product launch you need to be prepared for everything that you're going to be doing at approval. And as you say, that's not just preparing the sales force in terms of the training materials, it's also understanding the payer environment, it's preparing the rest of the organization and also, outside of commercial. So, on the medical side, our medical affairs organization will be prepared and, of course, we'd be preparing for months already, and even more than a year in terms of thinking through the brand strategy and how we're actually going to position this product in the market. And so, all of these elements and I think what I said is that, my experience in oncology launches, what I saw coming into Seattle Genetics is a team that is very prepared, I was really impressed.
Silvan Tuerkcan -- Oppenheimer & Co. -- Analyst
Great. Thanks. And do you expect an Adcom?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
We can never make a comment on whether there is an Adcom or not, it's not our decision, but we do have breakthrough therapy designation. And I think that -- I don't want to handicap this actually. But we're thinking pretty positively about this drug.
Roger, any addition?
Roger D. Dansey -- Chief Medical Officer
Agree.
Silvan Tuerkcan -- Oppenheimer & Co. -- Analyst
Great, thanks. And maybe just quickly, for tucatinib. I think the brain metastases will be very important and it's great that you're studying it. What -- do we have seen any data on activity in brain metastases to date and earlier trials and will this data be top line and same time you may put top line the PFS of the entire trial? Will it be mature enough at that point?
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
So, there has been data early on in looking -- in single-arm trials, not in the randomized setting at brain metastasis. And with relatively really nice data, that was something that stuck out on us as we reviewed this, that we were surprised with -- not surprised, but we were pleased, I should say, we're seeing the data in brain mets that we did with a single-arm trial. Yes, you have to do this in a randomized trial to prove it but the data in brain mets was well -- was better, considerably better than you would have expect to see in populations of brain met patients, based on looking at other drugs at historic studies, but you have to do the randomized study. So, that's it.
Roger, any other comments on this?
Roger D. Dansey -- Chief Medical Officer
I agree, Clay. So, the data that was generated, clearly tucatinib is active in brain metastases that I think is no doubt. And so, it's a matter of how active in the combination that we're testing.
With regard to what we will release top line, I don't think we'll get into any specifics about what data would be obtained in that release.
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Yeah. That's too premature to say what will exactly released now. Our goal will be to release everything that we possibly can while retaining the ability for doctors to present this at an appropriate, peer-reviewed, large conference. And, I mean, breast cancer work is normally presented at conferences, such as the San Antonio meeting, which specializes in breast cancer, but also is at ASCO and ESMO and some other cancers. But the San Antonio conference is clearly the premiere breast cancer conference or it's evolved to being the premiere breast cancer conference, didn't used to be that way but it is now.
Silvan Tuerkcan -- Oppenheimer & Co. -- Analyst
Great. Thank you so much.
Operator
Ladies and gentlemen, this concludes today's question-and-answer session. I would like to turn the conference back to your speakers for any additional or closing remarks.
Peggy Pinkston -- Vice President, Investor Relations
Okay. Thank you, operator, and thanks everybody for joining us this afternoon. Have a good night.
Operator
[Operator Closing Remarks]
Duration: 74 minutes
Call participants:
Peggy Pinkston -- Vice President, Investor Relations
Clay B. Siegall -- President, Chief Executive Officer and Chairman of the Board
Robin G. Taylor -- Chief Commercial Officer
Todd E. Simpson -- Chief Financial Officer
Roger D. Dansey -- Chief Medical Officer
Kennen MacKay -- RBC Capital Markets -- Analyst
Matthew Thomas Holt -- JPMorgan -- Analyst
Michael Schmidt -- Guggenheim -- Analyst
Andrew Berens -- SVB Leerink -- Analyst
Maryana Breitman -- Goldman Sachs -- Analyst
Gena Wang -- Barclays -- Analyst
Tazeen Ahmad -- Bank of America -- Analyst
Steven Wiley -- Stifel -- Analyst
Shanshan Xu -- Berenberg Capital Markets -- Analyst
Andy Hsieh -- William Blair -- Analyst
Silvan Tuerkcan -- Oppenheimer & Co. -- Analyst
