Seagen Inc (SGEN) 2017 Q1 法說會逐字稿

Good day, and welcome to the Seattle Genetics First Quarter Financial Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the call over to Peggy Pinkston, Vice President, Investor Relations. Please go ahead.

Thank you, operator, and good afternoon, everyone. I'd like to welcome all of you to Seattle Genetics First Quarter 2017 Conference Call. With me today are Clay Siegall, President and Chief Executive Officer; Todd Simpson, Chief Financial Officer; Eric Dobmeier, Chief Operating Officer; Jonathan Drachman, Chief Medical Officer and Executive Vice President, Research and Development; and Darren Cline, Executive Vice President, Commercial.

Following our prepared remarks today, we will open the line for questions. If we are unable to get to all of your questions, we will be available after the conclusion of the call. Today's conference call will include forward-looking statements regarding future events or the future financial and operating performance of the company. Such forward-looking statements are only predictions based on current expectations, and actual results may vary materially from those projected. Please refer to the documents that we file from time to time with the SEC, including the company's Form 10-K for the year ended December 31, 2016, for information concerning the risk factors that could cause actual results to differ materially from those contained in any forward-looking statements.

Now I'll turn the call over to Clay.

Thanks, Peg, and good afternoon, everyone. Thank you for joining us. Today, we'll discuss upcoming activities and review recent progress towards our goal of becoming a multi-product oncology company. I'll start with a summary of our 3 main areas of focus. First, building ADCETRIS into a major global brand; second, advancing our late-stage clinical programs, notably vadastuximab talirine or 33A and enfortumab vedotin or 22ME; and third, investing in a robust pipeline of earlier-stage programs, including SGN-LIV1A and others across both hematologic malignancies and solid tumors.

Our first quarter sales of ADCETRIS in the U.S. and Canada were $70.3 million, a 20% increase over the first quarter of 2016. We remain on track with our 2017 guidance for ADCETRIS product sales in our territory of $280 million to $300 million. We are executing well commercially with our current labels. We are also preparing for several significant clinical and regulatory milestones intended to drive future growth of the ADCETRIS franchise. These are based on 3 Phase III trials: ALCANZA, ECHELON-1 and ECHELON-2.

Starting with ALCANZA. We plan to submit a supplemental BLA to the FDA in mid-2017. As a reminder, our Phase III ALCANZA trial was conducted in CD30-expressing cutaneous T-cell lymphoma. The results showed a highly statistically significant benefit in favor of ADCETRIS across the primary and all secondary endpoints. We've received breakthrough therapy designation for ADCETRIS in CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma, the most common subtypes of CTCL.

We plan to submit the ALCANZA data to the FDA, along with data from 2 investigator-sponsored trials in other subtypes of CTCL with the goal of obtaining a broad label in CTCL. The submission is on track for mid-year. Another significant upcoming activity for the ADCETRIS program is the release of top-line data this year from our Phase III ECHELON-1 trial in frontline Hodgkin lymphoma. The ECHELON-1 trial is assessing modified progression-free survival in newly diagnosed advanced Hodgkin lymphoma patients.

Patients were randomized to either receive -- to receive either an ADCETRIS containing regimen called A+ ABD or the standard of care known as ABVD. This trial represents a substantial opportunity for ADCETRIS to redefine and improve the treatment paradigm for newly diagnosed Hodgkin lymphoma patients, which has not changed in decades.

Looking ahead to 2018. We expect to report data from ECHELON-2, our Phase III trial of ADCETRIS in front-line mature T-cell lymphoma often referred to by clinicians as peripheral T-cell lymphoma. We are evaluating progression-free survival of ADCETRIS plus CHP compared to standard-of-care CHOP, or CHOP chemotherapy, in newly diagnosed patients. This is a second opportunity to redefine and improve outcomes in a frontline non-Hodgkin lymphoma patient setting that has not changed in many years.

I'll now turn to vadastuximab talirine, or SGN-CD33A. We are conducting trials of 33A in AML and myelodysplastic syndrome, both of which broadly express CD33. Our first registration pathway with 33A is the ongoing CASCADE Phase III trial in older patients with AML. CASCADE is a global randomized study, comparing 33A plus decitabine or azacitidine to either of these hypomethylating agents alone. The primary endpoint is overall survival. Enrollment has been strong towards our target of over 500 patients.

We are also advancing 33A in frontline younger patients with AML. We plan to initiate a randomized Phase II trial later this year, adding 33A to the standard regimen of cytarabine and daunorubicin or 7+3. This trial is designed to assess whether adding 33A to the standard frontline regimen can improve MRD negative TR [rates] and event-free survival in frontline fit AML patients. Our rationale for advancing 33A into 2 late-stage AML trials is based on data from separate Phase I trials. One of 33A plus HMAs in older AML patients and another of 33A plus 7+3 in younger AML patients.

As reported at ASH in December, in both trials, the composite complete remission rate was more than 70%. And notably in both studies, we observed a high percent of responders who were negative for minimal residual disease. In these single-arm trials, interim survival measures were superior among responding patients who achieved MRD negative remissions compared to responding patients who were not MRD negative. Based on these data, we believe that adding 33A to standard regimens for AML could potentially be well tolerated and yield superior outcomes to standard treatment alone.

In addition to AML, we are evaluating 33A in myelodysplastic syndrome through an ongoing Phase I/II trial. In this trial, we are pursuing a similar strategy, combining 33A with azacitidine in newly diagnosed patients with high-risk MDS and comparing tolerability and activity with azacitidine alone. Next, I'll provide an update on enfortumab vedotin or 22ME, our lead ADC for solid tumors. 22ME is in clinical development for metastatic urothelial cancer under our co-development collaboration with Astellas. Based on positive feedback from the FDA, we intend to initiate a pivotal monotherapy Phase II trial in patients previously treated with a checkpoint inhibitor, with the intent of providing the data for potential registration under the FDA's accelerated approval regulations.

We plan to initiate the study in the second half of 2017. We believe that 22ME could play an important role in this setting. This is an unmet medical need given that the majority of patients treated with checkpoint inhibitors fail to respond and require further treatment options. We are also planning to combine 22ME with checkpoint inhibitors in a trial that we expect to begin late this year as part of our broad clinical development program. We are positioned for several key milestones in 2017 that have the potential to significantly advance Seattle Genetics towards our goal of improving the lives of people with cancer and further establish the company as a leader in the field of oncology. We are expanding globally and are in a strong financial position to continue executing on our priorities.

Now I will turn the call over to Darren to discuss our commercial activities. After that, Todd will discuss our first quarter financial results, and then Jonathan will highlight our research and development progress. Darren?

Thanks, Clay. In the first quarter, ADCETRIS sales were $70.3 million, an increase of 20% over the first quarter of last year. ADCETRIS continues to be the standard of care in its original approved indications of relapsed HL and relapsed ALCL. As the brand approaches its sixth year on the market, strong long-term follow-up data from our initial pivotal trials have further enhanced the clinical value proposition in these settings today. Despite the recent FDA approval of a second PD-1 inhibitor in relapsed Hodgkin lymphoma setting, we have seen no erosion in share in our existing relapsed HL business. Most prescribers have indicated they view the checkpoint inhibitor agents as interchangeable and would use both in post-ADCETRIS later lines of therapy or palliative setting, if necessary. Beyond our current business, we're continuing to prepare ADCETRIS to become a major global brand.

Our commercial resources are focused on launch preparedness for our upcoming CTCL indication and, most importantly, our frontline Hodgkin lymphoma indication. In the near term, the CTCL approval will represent another important commercial milestone for ADCETRIS. Physicians and market research have been impressed with the strength of the ALCANZA data, and we believe it supports our goal for ADCETRIS to be the foundation of treatment for CD30-expressing lymphomas.

Leading up to ECHELON-1 results, we've invested resources to better understand how ADCETRIS plus ABD will be integrated into current practice in both community and academic settings and how we can ensure rapid adoption of this novel regimen in the event of FDA approval. In parallel, we are also continuing education efforts to raise awareness and highlight the unmet need that exists specifically for advanced-stage Hodgkin lymphoma patients who currently receive ABVD.

Lastly, our ECHELON-2 trial will potentially provide patients and providers a new targeted therapy option beyond traditional chemotherapy that will address the high unmet need in newly diagnosed T-cell lymphoma. Although we are in the early stages of commercial planning for the E2 launch, we have been ensuring our education efforts in CTCL and ALCL will be complimentary to our frontline MTCL approval education efforts in the future.

I look forward to updating you on our progress and preparing for these important opportunities for ADCETRIS. Now I'd like to turn the call over to Todd to discuss our financial results.

Great. Thanks, Darren, and thanks, everyone, for joining us on the call this afternoon. We ended the first quarter with $536 million in cash and investments. This, along with our strong ADCETRIS sales and our collaborations, enables us to continue executing on our strategy of expanding the ADCETRIS label, advancing our 33A and 22ME programs and investing in the rest of our oncology pipeline. Today, I'll summarize our financial results for the first quarter of 2017.

Total revenues in the first quarter were $109 million, including ADCETRIS net sales of $70 million. As Clay mentioned, we continue to expect that total ADCETRIS sales for 2017 will be in the range of $280 million to $300 million. Royalty revenues in the first quarter were $17 million compared to $32 million in the first quarter of 2016. Recall that in the first quarter of last year, royalties included a onetime $20 million sales milestones from Takeda. Excluding that milestone, first quarter 2017 royalties increased 38% compared to last year. This was driven by higher Takeda sales and by those sales reaching a higher royalty rate tier in the fourth quarter of last year. As a reminder, the royalty rate paid by Takeda begins in the mid-teens, increases to the high teens at $100 million in sales, into the low-20s at $200 million and, ultimately, to the mid-20s. Since the rates reset annually and because we report royalties 1 quarter in arrears, royalty revenues will decrease in the second quarter, although we continue to expect them to be in the range of 55 -- $50 million to $55 million for the full year.

Collaboration revenues were $22 million in the first quarter, driven by amounts earned under our ADCETRIS collaboration with Takeda and our ADC deals. R&D expenses were $118 million in the first quarter. ADCETRIS continues to be the primary driver of R&D expense and the increase over the first quarter of 2016 reflects investments in 22ME, 33A and our broad pipeline. SG&A expenses were $38 million in the first quarter, also in line with our expectations.

Now I'd like to turn the call over to Jonathan.

Thanks, Todd. We are positioned for several very important activities this year with ADCETRIS, 33A and enfortumab vedotin. We're also advancing and expanding our pipeline and conducting innovative research to remain the industry leader in ADC technology. With ADCETRIS, we're preparing the supplemental BLA submission for labeling CTCL. Our ALCANZA data were remarkable, and we believe ADCETRIS can make a meaningful difference for CTCL patients who require systemic therapy to treat this debilitating disease.

In collaboration with Takeda, we're also preparing for top-line data from our Phase III ECHELON-1 trial in frontline Hodgkin lymphoma. This large global trial has the potential to redefine the way newly diagnosed patients, mostly young adults, are treated by adding ADCETRIS and removing bleomycin from the standard regimen. It is exciting that this year, we expect data that could drive improved outcomes for patients with advanced Hodgkin lymphoma.

With 33A, our development focus is on myeloid malignancies including AML and MDS. We are encouraged by the significant percentage of MRD, or minimal residual disease, negative remissions achieved by patients in our Phase I AML trials. MRD negative remissions are more stringent and deeper than traditional response criteria and have been associated with better patient outcomes. As we reported at ASH from our Phase I trial, interim data suggests that patients who achieve MRD negative status live longer than those who did not, regardless of whether they achieve a CR or a CRI. We will be evaluating MRD status in our CASCADE trial for older unfit patients and in our planned Phase II randomized trial in frontline younger AML patients.

With enfortumab vedotin, we're working with regulators on refining our development plan for this program in metastatic urothelial cancer and look forward to initiating a registrational trial later this year. In addition, at the upcoming ASCO Annual Meeting in Chicago, follow-up data in patients with metastatic urothelial cancer from the Phase I trial of 22ME will be featured in an oral presentation. We're also evaluating additional tumor types in the ongoing Phase I trial including ovarian and non-small-cell lung cancer.

And lastly, we and Astellas recently initiated a Phase I trial of 22ME in Japan. This trial will enable future studies and regulatory submission in Japan. We and Astellas believe that enfortumab vedotin has the potential to become an important therapy around the globe for patients with urothelial cancer. In addition to our lead programs, we are advancing several other clinical-stage programs notably SGN-LIV1A and ADC in development for metastatic breast cancer including triple-negative disease. We are continuing to optimize the dosing schedule in Phase I and expect to report additional data from SGN-LIV1A later this year. We are enthusiastic about the opportunity for SGN-LIV1A in triple-negative breast cancer, and we are evaluating next steps for this program including potential registrational approaches and combination regimens.

At AACR earlier this month, we showcased our advances in research and preclinical development. Some notable presentations included reporting preclinical data demonstrating that ADCETRIS induces immunogenic cell death resulting in an inflammatory tumor micro microenvironment and added activity when combined with inhibitors of the PD-1, PD-L1 pathway. Under our collaboration with Bristol-Myers Squibb, we're conducting clinical trials with ADCETRIS and nivolumab in multiple Hodgkin and non-Hodgkin lymphoma settings.

In support of our own immuno-oncology portfolio, we reported preclinical data on SEA-CD40 that demonstrates activation of an antitumor immune response and potential for combination with checkpoint inhibitors. SEA-CD40 is an immuno-oncology agent that is in a Phase I trial for the treatment of both solid tumors and hematologic malignancies. In addition, pre-clinical data were presented supporting the ongoing Phase I study of SGN-2FF for patients with advanced solid tumors including non-small-cell lung cancer. SGN-2FF is an oral small molecule immuno-oncology agent that has been shown to inhibit fucosylation of protein and thereby stimulate the immune system to slow the growth and spread of cancer.

There were also several presentations that highlighted advancements in linker technologies for payloads, which enable development of novel ADCs, including the planned clinical program SGN-CD48A for multiple myeloma. And finally, Unum Therapeutics reported preclinical data with our sugar-engineered antibodies in combination with engineered antibody coupled T-cell receptor or actor cells. Under our collaboration, Unum plans to initiate a Phase I trial for patients with multiple myeloma targeting BCMA.

Seattle Genetics is built on innovation and scientific excellence. I'm proud that even as we are advancing multiple exciting programs into registrational studies, we continue to focus on maintaining our leadership in the ADC field and broadening our pipeline by advancing multiple immuno-oncology programs at the clinic.

Now I'll turn the call back over to Clay.

Thanks, Jonathan. Before we open the line for questions, I'll summarize our key upcoming activities. For ADCETRIS, these include: submitting a supplemental BLA to the FDA for CTCL in mid-2017; reporting data from the Phase III ECHELON-1 trial in frontline Hodgkin lymphoma this year; and reporting data from the Phase III ECHELON-2 trial in frontline MTCL in 2018. For 33A, we are advancing the Phase III CASCADE trial in frontline older AML and a Phase I/II trial in frontline MDS. In addition, we plan to initiate a randomized Phase II trial in the second half of the year in frontline younger AML patients.

Lastly, for 22ME, together with Astellas, we plan to initiate a pivotal Phase II monotherapy trial in the second half of 2017 for metastatic urothelial cancer patients who have previously been treated with a checkpoint inhibitor. We are also planning a trial in combination with a checkpoint inhibitor to begin later this year. And we will report additional Phase I data at ASCO. We will keep you updated on our progress as well as activities across our earlier-stage pipeline programs.

At this point, we will open the line for Q&A. Operator, please open the call for questions.

(Operator Instructions) We'll take our first question from Michael Schmidt with Leerink Partners.

I had a follow-up question on your ASG-22ME discussions with the FDA. And I was just wondering if you could provide some more color there in terms of the feedback that you received, for example, the number of patients, what is the potential size of this Phase II study? Which endpoints could be used here? And what is the approval hurdle potentially?

Okay. Michael, thank you very much for the questions. So what I would say is it was a positive meeting with the FDA. The trial you asked about, and at this point what we're saying is it's a modest sized trial with a relatively rapid time frame. We mentioned it's a single arm monotherapy trial of patients who previously have been treated with checkpoint inhibitors, and this would be under the accelerated approval pathway within the FDA. But we're -- so overall, we're really excited with the data from 22ME. We previously presented data. At ASCO this year, you'll be hearing more data. And in fact, it's an oral presentation, so that was fantastic. So there will be a lot of data that will be represented. And we're also going to do, we said we're going to start a trial of 22ME with checkpoint inhibitors. And the thing that I really like about that is you have the high overall response rate of an ADC and then you have this long durability of a checkpoint. And together, that could be really exciting, and we've seen evidence of that with ADCETRIS Opdivo. So we're excited with that. But for the approval trial, that is the single-arm monotherapy.

Okay, great. And then I had a follow-up regarding Hodgkin lymphoma, in particular, around your activities in second-line Hodgkin lymphoma, potentially. I'm just wondering if you could just provide some more color there on your activities and sort of what your strategy and next steps are regarding the second-line Hodgkin lymphoma setting.

Sure. So we previously presented quite a lot of data in second line. As you know, in frontline, we're trying to really redefine frontline with ADCETRIS ABD, and that's the E1 trial. But in second line, I think when you look at what we've done historically, I think we've taken 2 approaches. We had ADCETRIS plus bendamustine. And we had quite a lot of data there with a CR rate over 80%. So that is a one way to consider, although bendamustine does have some toxicities that are well known. The other approach, which we've done of late, and perhaps I'm even more interested in, is ADCETRIS plus checkpoint inhibitors and we put data out on ADCETRIS plus Opdivo at the appropriate cancer conferences. And the data looks really good. Now we -- at this point, we haven't said anything specific on how we're going to follow it up. I mean, those trials also were done with a -- in partnership with Bristol-Myers Squibb. So they were done together with them. We've had a good relationship. We started out with 2 trials, we added a third trial in our relationship. So I think that's good and I would say, stay tuned for more information as soon as we can provide it in that area. But it's something that we're very keen to look at.

We'll take our next question from Geoff Meacham with Barclays.

It's Paul Choi. Thanks for taking our questions. Could you maybe provide a little bit of color on your, perhaps, pre -- CTCL activities in terms of position awareness and how they're thinking about current standard of care versus what you could do with ADCETRIS?

Sure. I'd be delighted to talk about that. But probably better for Darren to talk about what our commercial team is doing to prep for CTCL based on the fantastic data, remarkable data that we had with ALCANZA.

Yes, thanks, as I alluded to in the prepared remarks, we've been doing a lot of market research around the ALCANZA data and physicians are, quite frankly, stunned at the results. And if you think about the CTCL patient population, there are about 2,000 that get systemic therapy annually in the U.S., about 1,000 that express CD30. But as we think about the label and the implications, we're focused on identifying who the appropriate treaters are, again, because this is somewhat of a rare disease, and it's really been segmented with a few key positions and treatment sites throughout the United States. So we're focusing on that. Our marketing team is preparing and doing message testing, et cetera, to quickly, upon approval, get the data sets in front of the patients, so -- or, excuse me, the physicians, so we'll have the rapid uptake with these physicians. So we're excited. The physician community is excited. They're most excited for a new option that, if you think about cutaneous T-cell lymphoma, it's a very visible disease to both, obviously, the patients and the physicians. And I think with data like ADCETRIS in this setting, we're going to see, I think, patients see remarkable results. So we're excited about it, physicians are and so are patients.

And I'd want to add one thing about CTCL. So we have breakthrough designation from our ALCANZA trial. And so we have had a good opportunity to collaborate and discuss with FDA all of our data. And you may recall from earlier conference calls that we initially had guided that we would be submitting earlier in this year. And then we changed our guidance at our last conference call to mid-year, and that was because of our discussions with the FDA based on other data that we've had from investigator-sponsored trials, specifically 2 of them, which showed strong activity in CTCL with patients that were below the histology cut off that we used in our ALCANZA trial and with patients that were in other subtypes of CTCL. So our goal in presenting our data, ultimately, submitting a supplemental BLA, is to try to get the -- help the most patients that we can, and that might be with helping all patients with CTCL. It's not clear that based on histology is the right way to select the patients. And that, in fact, our data says otherwise. And so -- and when you look at the listing in compendia, that does not have a CD30 cut off. So we think that we are in a good position to submit all our data, ALCANZA and from 2 other trials, to try to get the broadest label that we can and help the most patients we can. But that's been our goal, and we've been talking about that.

We'll go next to Cory Kasimov with JPMorgan.

This is Chuan Fu on for Cory Kasimov. I want to add my congratulations for the great quarter. Maybe if I could just ask one about the long-term side effects of the regimen on ECHELON-1. Obviously, one of the big value-adds is being to take away the bleomycin and so avoid the long term long scarring and fatigue. So I'm wondering if I could ask, what do we know about the long-term side effects of ADCETRIS plus ABD, specifically something I'm thinking about is the fact that, in the front-line, you have the vinblastinol [sic] [vinblastine], so now you have 2 microtubule disrupting agents in the same regimen. Is there concern that this might lead to some long-term peripheral neuropathy?

Thanks for the question, very much. Let me start by just saying that with E1, we are trying to accomplish 3 things, you mentioned one of them. First of all, with E1, we're trying to get to a higher cure rate. It's been 40 years since ABVD has come out, and based on our lead-in trial, we think that we are in great shape to potentially see a much higher cure rate, that's the goal of the trial. And when we have the data, we'll be able to talk about that, and we're excited that it's this year. So the first thing's higher cure rate. The second thing is getting rid of bleomycin, which you mentioned. There's this incredible lung scarring, in some patients it's fatal in a short time frame, and there's also late effects of bleomycin on patients. So that's something we're really looking to get rid of, and certainly ADCETRIS plus ABD does that. And lastly, what we want to do, and important, is to try to really minimize the use of radiation in these patients, and you could do that if you get a much higher CR and cure rate. And radiation on the heels of chemotherapy results in Hodgkin lymphoma having one of the highest secondary malignancy rates of all cancer. And so we're trying to do those 3 things here. And as far as the long-term effects, I'm going to turn this over to Jonathan to talk about it. But so far, we've been very pleased with the profile of ADCETRIS in Hodgkin patients.

Yes, so thanks. So Chuan, it's a good question. I'll start off by saying that with alkaloids including vinblastine and vincristine, as well as with ADCETRIS, the peripheral neuropathy is reversible. And so we haven't seen permanent neuropathy as a significant issue with any of this class of agents. Secondly, vinblastine has much less peripheral neuropathy than vincristine, so in this regimen, that's less of an issue. And thirdly, we did a lead-in study where 26 patients got this regimen, and we followed and reported their amount of peripheral neuropathy and their recovery, and it was quite reasonable and well tolerated. So I think we're in pretty good shape with that.

Okay, perfect. And if I might just add a brief follow up, so just to confirm the patient population in ECHELON-1. So looking at that Phase I study you just talked about with the 26 patients, it looks like there was some small amounts, about 16% of stage 2 patients in there. Now for ECHELON-1, is this true as well? Or is it just purely confined to Stage 3 and stage 4 patients?

It's Stage 3 and 4 for ECHELON-1.

We'll go next to Salveen Richter with Goldman Sachs.

Regarding your earlier commentary on seeing the PD-1s being used in layer liner palliative settings, just wondering whether there is a discrepancy between the academic and community settings where in the community setting, they may not see as many HL patients, but they use PD-1s pretty frequently. Just wondering if there's a different trend playing out.

We study very closely the doctors using ADCETRIS. We've been on the market now for over 5 years. So Darren, can you talk a little bit about what we've seen in the marketplace now that there are 2 checkpoint inhibitors, Opdivo and KEYTRUDA, approved to treat Hodgkin lymphoma in certain settings?

Yes, sure. Regarding the academic and community setting, there is a difference, and we do monitor, obviously, both those settings. But I will say in, what we call, the academic setting or the key opinion leader setting, we, as I noted, the most recent PD-1 approval, we reached out and talk to a lot of these key opinion leaders in the academic setting. Their feedback, initially, on the label and on the data is exactly how we see the PD-1's being used now, which is predominantly after ADCETRIS. And I think what's the differentiator, and Clay alluded to it, we're in our sixth year on the market, and we have some really, really good long-term data now in ADCETRIS in the relapsed refractory Hodgkin lymphoma setting. And intent in these patients is to get the absolute best response. And when you don't get that with ADCETRIS, now there's an option with a PD-1. So we're not seeing, at this point, the delineation of use between academic and community, but it's something we continue to follow.

Great. And just a follow-up. Clay, I know you've mentioned that regulators are -- with regard to ECHELON-1, that regulators are focused on the survival curves and the plateau there. And that you were going to monitor this study after the event [accrual] begins to slow down. Just wondering if there's anything you can tell us about where you are in that kind of phase of monitoring.

Thanks for the question. So let me restate that, what we've stated before. It's progression-free survival, that is not survival. So let's just make sure that we're on the same page. And in fact, moreover, it's modified progression-free survival is our end point, and that was agreed-upon with all the regulators. And there's only a slight difference between PFS and modified PFS basic and, basically, if someone goes onto another therapy, they're an event. So we've not provided the number of events that we're going after here. But we are very pleased that, this year, we're going to be unblinding E1. And for the company, this has been a long path. For me, personally, this has been one of my missions to try to really redefine frontline Hodgkin lymphoma and I started on this mission, probably, 18 years ago. So it's a big year for me, a big year for the company as we go after this. And I think -- we look forward to working with regulators on our primary endpoint of PFS, modified PFS.

We'll go next to Yatin Suneja with SunTrust.

The question is on SGN-CD33A. Could you comment on Pfizer Mylotarg? I think they have filed for it. What happens once it gets approved? Do you think it could impact the market opportunity for your candidate and any particular population where your drug might be differentiated or you expect it to have a superior profile relative to that drug?

Yes. So thank you for the question. I love talking about 33A. So Mylotarg was a pioneering molecule. I mean, this is decades old technology that really was one of the leading edges of the field a long time ago in making antibody drug conjugates. And so Mylotarg uses, like in the vial, it's about -- half of it is pre-antibody and their linker is not very stable and the drug is sensitive to multidrug resistance. And despite these limitations, there's a benefit in patients. And so they've shown that you figure out a dosing schema for use in patients in combination with 7+3 in younger patients and have a survival advantage. So I'm thrilled that there's ways to help patients with AML. I mean it is, arguably, one of the worst cancers on the planet and basically is life-threatening to all patients that are diagnosed with AML. And so new therapies are important that have a good benefit to risk ratio. As far as impacting us, it actually is almost a positive. I mean, we think that our drug is very differentiated from Mylotarg. But please note that our Phase III right now is a CASCADE setting, is in older patients. And the approval they're looking for is in younger patients. So our initial accelerated approval pathway or whatever pathway we go down to get approval or full -- or regular approval because it will be survival, whatever we do initially is not in direct conflict with what they are looking at today. Now we, earlier on this call, said that we are going to be starting a randomized Phase II in combination with 7+3, that would be in a similar data set to where they have some data. So -- but that's just really just starting late this year and having the ability to help patients early is great. And then having our data later to show very differentiated data -- now we presented data at ASH last year of 7+3 plus 33A and the data was fantastic, which is why we are interested in doing more late-stage trials, and this randomized trial that we discussed earlier that's going to start later this year. So we're really pleased where we are, and we hope that any drug for AML is successful with patients.

That's very helpful. And then maybe could you give us an update on the Immunomedics deal? What are the next steps there? What is the typical duration for a litigation case like that?

Yes, sure. The Immuno deal is -- right now it's a legal issue, and so we're not providing any specific updates. As you know, the facts are there was a temporary restraining order, a TRO, and the fact is that there is a trial listed in late June. But please keep in mind that when we think about IMU 132, this was something that we thought fit in and we thought would be nice to have with the rest of our very extensive pipeline, but it is certainly not something that is needed. We have many programs that we are focused on and pushing forward hard on. But otherwise, the answer to your question, it's a legal issue, and it's not appropriate to make comment.

(Operator Instructions) We'll take our next question from Andy Hsieh with William Blair.

This is Andy Hsieh on for John Sonnier. We have a question about the future 33A trial design, in particular, as you move from elderly population to younger fit population transplant becomes an option for these patients, but also could be a significant confounding factor. So we're just curious if you have any strategies in place to minimize the imbalance risk.

Yes, thanks very much for the question. And we've actually thought about this a lot, and I think we have a great plan. Jonathan, would you like to expand a little bit?

Sure, yes. So we haven't talked about the exact design for our trials in younger patients. And you can look forward to hearing more about that later this year. It's true that for most patients who have poor-risk cytogenetics or even intermediate-risk cytogenetics, the goal in front-line treatment is to get them to a minimal residual disease negatives status and then often to take them to a transplant for a cure. And that is something that would likely happen in any setting, for example, that's what happened in the Mylotarg study where they're moving forward towards a potential approval. What we did, and worked closely with the FDA on, in reviewing all the data from our patients, of which we've had many patients who have gone on to transplant, I think we reported over 50, is that we have not seen a significant increased risk of any toxicity, including VOD in those patients that have gone on to transplant over what has been historically reported. And obviously, in a future randomized Phase II study, there would be a control arm, and that'll be very helpful. And we've also talked about having committees of external experts who are able to look at emerging toxicity. So I think we're well positioned, and we're going into this fully understanding how -- what the risks are, but also the potential for 33A to really make a difference in these patients.

With no further questions in the queue, I would like to turn the call back over to Peggy Pinkston for any additional or closing remarks.

Thank you, operator, and thanks, everybody, for joining us this afternoon. Have a good evening. Good night.

This does conclude today's conference. We thank you for your participation. You may now disconnect.