ImmunoGen Inc (IMGN) 2020 Q3 法說會逐字稿

Good morning and welcome to the ImmunoGen Third Quarter 2020 Financial and Operating Results Conference Call. Today's conference is being recorded.

Now I'd like to turn the call over to Courtney O'Konek, Senior Director of Corporate Communications and Investor Relations. Please go ahead.

Good morning and thank you for joining today's call. Earlier today, we issued a press release that includes a summary of our recent progress and third quarter 2020 financial results.

This press release and a webstream of this call can be found under the Investor and Media section of www.immunogen.com. With me today are Mark Enyedy, our President and CEO; Susan Altschuller, our Chief Financial Officer; and Anna Berkenblit, our Chief Medical Officer; Stacy Coen, our Chief Business Officer, will also join us for Q&A.

During today's call, we will review key accomplishments for the business over the last 3 months, our financial results and upcoming milestones. During the discussion, we will use forward-looking statements and our actual results may differ materially from such statements. Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings.

And with that, I'll turn the call over to Mark.

Thanks, Courtney. Good morning, everyone, and thank you for joining us today. We've generated significant momentum in the business over the last several months, achieving a number of important milestones across the company, while managing the challenges of operating in the COVID environment. Starting with our lead program, we were pleased to announce our strategic collaboration with Huadong Medicine to develop and commercialize mirvetuximab in Greater China.

This is the second largest pharmaceutical market in the world and Huadong's extensive research, development and regulatory capabilities, along with its access to a large network of local hospitals will allow us to realize mirvetuximab's potential to improve outcomes and bring more good days to women living with ovarian cancer in the region.

This partnership further strengthens our balance sheet with an upfront payment of $40 million, additional milestone payments of up to $265 million and tiered royalties on commercial sales. We look forward to working with Huadong to bring mirvetuximab to the market in Greater China and I thank the teams at Lazard and Ropes & Gray for their support in bringing this deal to fruition.

Beyond Greater China, we are working with a sense of urgency to execute on our pivotal trials and prepare for the first potential launch of mirvetuximab in 2022 in the U.S.

To this end, we continue to advance site activation and patient enrollment for both SORAYA and MIRASOL and are on track to report top line data from SORAYA in Q3 next year. In addition to a potential monotherapy label, we are committed to moving into earlier lines of therapy by combining with other agents. With the benefit of the encouraging data we shared at ASCO and ESMO earlier this year, we are working to define the best path to label expansion with our combination regimens and look forward to sharing our approach in a future call.

Moving to our earlier-stage programs, we were delighted to receive breakthrough therapy designation from FDA for IMGN632 for the treatment of relapsed or refractory BPDCN, underscoring the need for safe and effective treatments for this rare and aggressive cancer. We are engaged with FDA to further define the development path for BPDCN while continuing to evaluate 632 and AML and other hematological malignancies.

Finally, through effective execution and business development and deployment of our ATM facility, we have further strengthened our balance sheet and now expect our existing cash together with future payments from our partners to fund our operations into the second half of 2022.

With that, I'll turn the call over to Anna to review our clinical programs in more detail. Anna?

Thanks, Mark. We are pleased with the progress of mirvetuximab and our earlier-stage pipeline as we enroll patients in our SORAYA, MIRASOL, IMGN632 and IMGC936 trials. We are on track with mirvetuximab monotherapy. For SORAYA, we expect top line data during the third quarter of 2021 and the BLA submission before the end of 2021, to support approval in 2022. For MIRASOL, we expect to report top line data for this study in the first half of 2022.

Moving to our mirvetuximab combination regimens we presented final data from our FORWARD II triplet cohort evaluating mirvetuximab in combination with carboplatin and bevacizumab at ESMO in September. The platinum-sensitive triplet cohort evaluated 41 patients with recurrent platinum-sensitive ovarian cancer with medium or high levels of folate receptor alpha who have received up to 2 prior lines of therapy.

We observed a confirmed overall response rate of 83% with a median duration of response of 10.9 months and median progression-free survival of 12.8 months. I will also remind you of the mirvetuximab and bevacizumab doublet data presented at ASCO in May, where we observed an overall response rate of 64% in patients with high FR alpha expression regardless of platinum status.

The MIRV BEV data generated to date could support compendia listing and given the observed responses and favorable tolerability profile, we are working quickly to define a formal path to registration for mirvetuximab in combination and seek to expand into earlier lines of therapy. Moving to our earlier stage portfolio, we advanced our programs targeting both hematological malignancies and solid tumors. We continue to progress multiple cohorts with IMGN632 our anti-CD123 ADC including monotherapy expansions in BPDCN and minimal residual disease positive AML following frontline induction therapy, as well as combinations with azacitidine and venetoclax in relapsed/refractory AML.

We look forward to presenting updated data from the IMGN632 monotherapy BPDCN expansion cohort in an oral presentation and a trials and progress poster on the AML monotherapy and combination cohorts at ASH in December. In the ASH BPDCN abstract released earlier this week, 23 patients are included comprising the largest prospective study with a single agent in patients with relapsed/refractory BPDCN. We are pleased with the activity in these heavily pre-treated patients with high unmet need, including those with prior intensive chemotherapy, prior transplant and prior Elzonris with an overall response rate of 30% and clinically meaningful durations of response ranging from over 3 months to 9.2 months. IMGN632 also demonstrates a favorable safety and tolerability profile without capillary leak syndrome or need for hospitalization for administration. We look forward to Dr. Pemmaraju's presentation on Saturday, December 5.

Finally, we are pleased to have enrolled our first patient in a Phase I dose-escalation study evaluating IMGC936, our ADAM9-targeting ADC, which is being co-developed with MacroGenics in solid tumors including nonsmall cell lung, colorectal, pancreatic, gastric and triple-negative breast cancer and look forward to further advancing this trial.

With that, I'll turn the call back over to Susan to review the financials. Susan?

Thanks, Anna. For the third quarter of 2020, we generated $18.2 million in revenue, nearly all of which came from noncash royalty revenues. Operating expenses were $34.9 million compared with $31.2 million for the third quarter of 2019. This increase was driven by increased R&D expenses from greater clinical trial costs related to advancing our MIRASOL, SORAYA and 632 studies, partially offset by lower restructuring expenses. G&A expenses were $10.2 million compared to $9.2 million in the third quarter of 2019, primarily due to increased professional fees. At the end of the third quarter, we had $188.2 million in cash. Importantly, subsequent to quarter end, we brought in $54 million in net proceeds from our at-the-market financing, received $40 million in upfront payments from Huadong Medicine related to our partnership for the rights to mirvetuximab in Greater China, received an upfront payment from a newly executed license agreement with Viridian and will receive a $5 million payment from Novartis for development milestone achieved in September.

Updating our 2020 financial guidance, we now expect revenues to be between $60 million and $65 million, operating expenses to be between $160 million and $165 million, and our cash at the year-end to be between $245 million and $250 million. Please note that our revenue guidance does not include any potential impact from the agreement with Huadong Medicine. We are preparing for the potential accelerated approval for mirvetuximab in platinum-resistant ovarian cancer and are planning for increased investment in 2021 related to manufacturing and support of the commercial launch. With the addition of these investments, we expect that current cash and anticipated cash receipts from partners will fund operations into the second half of 2022.

With that, I will turn the call back over to Mark.

Thanks, Susan. Just a few closing remarks. We've made significant progress with the business over the course of 2020 and look forward to a strong finish to the year. We're excited about the future. With the benefit of the strong cash position and an experienced management team, we positioned the business to execute on a number of important milestones in 2021, including pivotal data and a BLA submission for our lead program, define the path to registration for 632 and BPDCN, as well as label expansion for mirvetuximab, generating initial data for IMGC936 and filing an IND for IMGN151. So I look forward to keeping you apprised of our progress in what are exciting times for the company.

With that, we'll open the call for questions. Operator?

(Operator Instructions) Our first question comes from the line of John Newman from Canaccord.

Just had a question on IMGN632, this asset has become really interesting, with the data that you presented for BPDCN as far as the breakthrough status. Just curious about how you're thinking about the registration pathway. Especially because, if you look at your CR rate, you're basically neck and neck with where Stemline was in the relapsed/refractory population.

So just curious as to how you're thinking about developing this asset in terms of registration?

Thanks, John. Yeah, we're very pleased with the activity we're seeing in relapsed/refractory BPDCN and we look forward to sharing updated data at ASH. Around the time of ASH, we also will be sharing plans in terms of our registration path forward. As we've discussed previously, our goal this year was to meet with FDA to define the path forward and we look forward to sharing that around the time of ASH.

Our next question comes from the line of Michael Schmidt from Guggenheim.

And congrats on the progress from me as well. On IMGN632 can you maybe provide a little bit more color on how much additional data we might expect here at the ASH Conference? And I did note that some of the PRs later converted to CRC. Just wondering if that's a general phenomenon with ADCs in this indication?

Thanks, Michael. So you may recall at ASH last year we had 10 BPDCN patients enrolled, 9 of whom were evaluable. And at the time of the data cut off for the abstract for ASH we had enrolled 23 patients, where you see we have a 30% response rate and now we do have a duration of response information, as you saw over 3 months to 9.2 months. So this duration of response data is quite nice in this relapsed/refractory population. We continue to enroll and we will present updated data on the entire dataset at ASH.

Okay. Great. And then an operational question I guess should you decide to file a BLA based on these data? How might this affect the Jazz Pharma opt-in rights? My understanding was that they may need to opt-in prior to BLA submission. Just wondering how that might work out structurally speaking?

Yes. Thanks, Michael. So the way the agreement works is there are essentially 2 opt-in periods. The first runs from the time we sign the agreement up until the initiation of pivotal development in AML. And the second opt-in period runs from that day through the BLA filing for AML. There's a little bit of nuance related to an interim filing for BPDCN, which is probably beyond the scope of this call. So the way I would characterize it is simply that they can opt-in early up till the initiation of a pivotal development for AML. And as I said, there is some nuance around BPDCN where if they have not opted in, there is a deferral period.

Okay. And then, Anna, I know when we think about the market size duration of treatment makes a big difference. Can you maybe comment on how duration of therapy in your study may compare to that, that has been seen with Elzonris?

So Michael, this is a little early for us to start talking about comparing Elzonris in terms of duration of response, but I would just remind you that with Elzonris duration of response in the absence of transplant is actually rather brief. With Elzonris, you do develop anti-drug antibodies and the median duration of response tends to be in the 3-month range again in the absence of transplant.

So we're pleased with the patients that we've enrolled thus far heavily pretreated post-intensive chemotherapy, some post-transplant, and some post-Elzonris and we've had durations of response north of 9 months.

Great. And congrats on all the progress.

Thank you.

Our next question comes from the line of Andy Hsieh from William Blair.

Great. Congrats on all the progress. Just a quick one for me. So I guess, The Street is not familiar with the China regulatory pathway. So I'm just wondering what needs to be done there in order to gain some sort of regulatory approval or marketing authorization? Is a full-blown Phase III trial needed or just basically a bridging study by complementing, I guess, both the FORWARD I, MIRASOL and SORAYA will be sufficient? So any sort of color on that would be super helpful.

Sure, Andy. So one of the reasons we chose Huadong is because of their expertise in developing drugs in China. And so we look forward to really clarifying the regulatory path for mirvetuximab in China. We are confident that we will need to generate data in patients in China and we're working with Huadong to figure out the most expedient path to doing so and we will get regulatory alignment with the Chinese regulators to do so.

Our next question comes from the line of Biren Amin from Jefferies.

Yes. Maybe on mirvetuximab, but do you think FDA will want to wait for the MIRASOL data before it considers a BLA that supported by SORAYA?

Well, that's certainly a possibility. That is not our base case assumption. The SORAYA data are really on track to be delivered a year ahead to allow us to have a filing before the end of next year. And so we don't think -- unless they have some concern, we don't think there will be any rationale for them to wait for the MIRASOL data.

Yes. And I guess, Biren, I pointed to the Trodelvy situation. Obviously, they had a delay in the sense that they had manufacturing issues that delayed them. But ultimately, they gained approval on the -- on its single-arm study while the -- and the Phase III study readout shortly thereafter. And so I think -- I think the FDA is prepared to take action, particularly where you have a significant unmet need on the basis of the data that are in front of them.

Got it. And then your strategy for a combination. I know in the past you've talked about potential compendia listing, but you've -- I think on this call today you mentioned that you would disclose some plans in a future call. Are you, I guess, as a company, reconsidering that strategy and would you potentially move forward with the registrational study in this setting?

Yes. So the way to think about it is additive. So we've generated a lot of good combination data and it would be those data that are the basis for submitting to the compendia to support listing and correspondingly reimbursement in the U.S.

As you know, in the absence of the label we would be constrained in terms of the ability to promote those data. And so the goal really is ultimately to gain a label, a label expansion in earlier line patients, and we think the best approach there like we will be 2 combinations either with Avastin or carboplatin. So that's what we're working through, as we speak.

Okay. And then maybe just a question on the BPDCN program with 632. Are there any plans in evaluating this in frontline, because if I look at your safety profile, you're not seeing any capillary leak syndrome or as I think we saw this with Elzonris. And then I guess what's driving that? Because it seems that we've seen this with other CD123 programs. So I just want to kind of understand that -- what's driving the safety profile?

Yes.So certainly, we're excited about further development of IMGN632 in both relapsed/refractory and the frontline setting. And actually, the protocol is currently open. We recently amended it is enrolling in frontline patients, we just started that. So I think from the safety profile perspective, it's very clear that IMGN632 has a very favorable safety and tolerability profile. We're not required to be hospitalized and we have not had capillary leak syndrome that is really been seen and can be fatal with Elzonris, and that's in large part due to the diphtheria toxin conjugate. ImmunoGen stopped working on diphtheria toxin conjugate many years ago. In terms of CD123 and other ways of targeting it with bispecifics, there is certainly cytokine release syndrome that can be problematic for those bispecific. So I think at this point, we're quite pleased with the safety profile that we're seeing.

Our next question comes from the line of Jessica Fye from JPMorgan.

I want to focus on ovarian for a minute. I know some of your slides, you talk about the number of platinum-resistant ovarian patients, but maybe just drilling into that more specifically, what do you see as the annual incidence of post-bevacizumab platinum-resistant ovarian cancer with 1 to 3 prior lines of therapy?

Yes. And to add one more criteria into that those that are folate receptor alpha positive at a high level. We think the annual incidents of the market for our proposed label would be 2,500 patients.

Okay. And do you think that...

And then if you exclude -- and we think, Jess, that the -- if you take away the previously treated with Avastin criterion it jumps to 5,000. So when we looked at the data from FORWARD I, which we think is a reasonably representative sample, in fact, half the patients had prior Avastin and half did not.

Got it. And is that in the U.S. or U.S. and Europe?

Yes. Those are the U.S. numbers. So what we are -- yes, we use a combination of data. So we buy data from DRG. We also have an agreement with Flatiron where we're looking at longitudinal cohort. And then we supplement that with the physician survey through Ipsos to get at those numbers. The DRG is the starting point.

Got it. And is there a possibility that the SORAYA trial could support European approval for mirvetuximab or do you anticipate needing control data like from MIRASOL?

Yes. So we will go talk to the EMA about the result of SORAYA, for sure. Their appetite for a single-arm studies to support approval historically has been limited in oncology. I've seen it done, done it with teams in my past life at Genzyme. So we will go out of the conversation and if that doesn't bear fruit, then it would be MIRASOL that would support full approval in the EU.

Okay. And then it sounds like you're kind of thinking about the path forward for mirvetuximab in combination. So what is the most kind of interesting possibilities there in your view and which are those that best maximize the commercial opportunity?

Yes. If you look at ovarian cancer today most patients on initial diagnosis following surgical debulking, I mean there is a fair amount of neoadjuvant use and we're actually looking at that in an IST. But the patients get either a platinum-based doublet or triplet with this third agent being Avastin. And so we generated some very nice triplet data that we shared at mature data at ESMO. But from a market opportunity perspective, I think obviously substituting mirvetuximab for paclitaxel in the doublet or the triplet would be the highest market opportunity. The challenge there is that's going to be a very large, a large study.

And so what we're looking at are opportunities to move into earlier line therapy, either using a strategy similar to the data that we share at ASCO, where the patients were platinum agnostic. That is, it was a mix of patients who were either resistant or sensitive, but later line patients. And the data we saw there in terms of response rate were quite compelling. We had a 64% response rate in those patients with high levels of folate receptor alpha expression.

So looking at that sort of third line and later platinum agnostic population are separately going after a nonplatinum-based regimen in platinum-sensitive patients to remain platinum sensitive, because what happens is, after a couple of lines of platinum there are a lot of reasons why physicians are not giving platinum to those patients. They're hypersensitivity, tired bone marrow, et cetera. And so what we see in our data is a growing population of those patients, where a combination regimen that doesn't include platinum. So, for example, mirevtuximab plus Avastin, could be a very nice alternative for them. So those are the -- those are our thoughts in terms of label expansion.

Our next question comes from the line of Boris Peaker from Cowen.

Great. I'm just curious for the MIRASOL as well as the SORAYA trial. As you're enrolling it what fraction of patients are you finding to fall into the folate receptor positive category based on your new assay?

So Boris, it's not a new assay. It's the assay that we have used from the beginning of the program, the PS2+ assay and we're tracking it exactly as we would expect. We know from testing over 2,000 patients that about 40% are FR alpha high.

Our next question comes from the line of Joe Catanzaro from Piper Sandler.

Maybe just one quick one. I guess now with a nice Greater China deal under your belt for mirvetuximab, how do you think about the potential for additional ex U.S. partnerships around that asset. I guess, namely Europe. And is that largely consistent on how you view your cash needs moving forward and whether maybe you could potentially create more value as SORAYA and MIRASOL readout in the near future?

Yes, Joe. I mean I think you said it well, which is this is a multi-variable equation here and we're looking at what resources we would need to bring to bear to launch the product versus what the value would be if bringing on a partner for -- in particular, Europe. We've done the analysis in Europe and it's a fairly concentrated market in terms of physician targets, treatment patterns and so on. Actually more concentrated than the U.S. that's offset to some degree by the need for national level commercial infrastructure.

So what you end up with are estimates of commercial and medical affairs, infrastructure similar to what you have in the Europe when you look at a sort of region to region comparison, but certainly within the ambit of a company like ImmunoGen particularly being able to finance on the back of positive pivotal data.

So that said, there are a lot of advantages to partnering as well. And so that's something that we will evaluate in particular with positive pivotal data in hand.

One thing I would add is with the China deal, and the $40 million upfront plus proceeds from the ATM. We've now updated guidance for our cash outlay until the second half of 2022 and we feel that we're in a position of strength. So we want to do the right strategic decision on partnerships because we -- CapEx optionality now that we strengthened balance sheet this quarter.

Our next question comes from the line of Jonathan Chang of SVB Leerink.

This is David Ruch on for Jonathan. First question, for 632, have you guys presented or do you have plans to present any duration of response data from the 71 patients treated with monotherapy at ASH of last year? And then second, could you provide any color on the enrollment progress in the combination cohorts and when we might see initial data from the AZA-VEN combos in AML piece?

So for the AML monotherapy data that we presented at ASH last year for IMGN632. We anticipate that when we write a manuscript for that, we will provide duration of response data. Moving to the combinations, we look forward to -- we're in the midst of planning an investor conference call event around the time of ASH, and that would be the appropriate time for us to provide a progress update on the combinations for IMGN632. We do have a trials in progress poster at ASH describing the study design combining with azacitidine with venetoclax and as a triplet and we are in the midst of that dose escalation.

Got it. And then just second, I noticed on the IGF-1R collaboration with Viridian/miRagen. We've seen some impressive sales figures already this year from Tepezza. And I was just wondering if you could provide any further specificity on your economics within the thyroid eye disease opportunity and timing of potential regulatory filing. And I guess, anything else here that you'd highlight about the promise of this opportunity.

Sure. So we're not divulging upfront numbers on that deal, but the structure is upfront milestones and royalties in a traditional type of fashion and we do have the opportunity to recognize approximately $50 million in development milestones and up to $95 million in sales milestones on that program. We do think it's well placed with Viridian there in a position to move that forward. As you know, we're focused on cancer here at ImmunoGen and we think that it's complementary to have them pursuing this asset in the thyroid eye disease indication, which has a very promising potential.

Our next question comes from the line of Kennen MacKay from RBC.

And congrats on what's been a really remarkable year here. I had another [BGE] question. Mark, I was wondering where are you fielding the most incoming interest these days? Is it from strategics relating to mirvetuximab or potential combination therapies for mirvetuximab and additional trials or cohorts that could be run there or earlier pipeline ADAM9 or more sort of platform interest looking to accessing linker and payload tech similar to the Viridian deal that we recently heard about?

Yes. So what I would say is we get it as the 2 ends of the spectrum. What I mean by that is there's inbound interest in mirvetuximab. Obviously, we've signed a deal for Greater China, but it's a late-stage oncology asset. And as you could imagine that tends to attract a lot of attention.

At the other end of the spectrum it is around the platform. With the recent success in terms of approvals in the ADC space, there is a lot of interest in the underlying technology. So we are fielding inbound similar to -- but catalyze the discussion with Viridian. And so those are the kinds of things we're entertaining. And I think as we see the progress, for example, with 936 which really integrates a number of important innovations that came out of our labs over the last half decade or so in terms of payloads, linkers and also some antibody engineering, people see that.

And I think as those -- as that program progresses, will probably -- that will generate even greater interest. And so we're excited about those things and being able to deploy the technology platform more broadly, so that's where it is. In the middle on both the 632 and ADAM9 are partners, so we're not getting any interest there. But those programs do have an innovation that has intrigued others to come knocking.

Got it. And Mark, maybe just elaborating on that a little bit. Obviously, there has been a lot of strategic interest in ADCs after the competitive in pneumatics acquisition and some of the deals that we've seen, Seattle -- Seagen rather now, inking relating interest in combination of ADCs with checkpoints. Maybe in ovarian cancer, I'm wondering if there are specific checkpoints that stand out as maybe the better sort of combination partners or really there's been any evolution in thinking around the field of a potential immuno-oncology partner in ovarian cancer? Partnering that combination drug sense not a...

Yes. So Ken, you may remember that we move forward with Merck combining with KEYTRUDA in ovarian cancer setting in platinum-resistant patients. And the initial responses were quite encouraging. However, when we expanded out the cohort, we didn't see a significant contribution in terms of efficacy beyond what we've typically seen in that population with single-agent mirvetuximab.

And so we have not pursued that further.

There have been some really interesting preclinical data. I would point you to a paper by Alfred Zippelius. It's a lab, I think, based in Switzerland. And what they showed was synergy in particular between these tubulin-acting agents and the checkpoint inhibitors. And to say that it's an encouraging early data which didn't pan out, but what I would say is, we're not averse to it, but Anna, has few other words to add here.

Yes. I think unfortunately, ovarian cancer is unlike many other tumors where checkpoint inhibitors have revolutionized the treatment paradigm. There have been several Phase III failures for checkpoint inhibitors at this point in ovarian cancer, with avelumab in the JAVELIN studies and with atezolizumab most recently in the IMagyn050 study, so they to be not very mutationally burden tumors. I would even go so far as to say checkpoint inhibitors could not really achieved proof-of-concept in ovarian cancer. So I think it would be unlikely. Unless there is a new target that's identified and the biology is strong for us to pursue combinations with the currently available checkpoint inhibitors.

All right. So -- but if we look at the earlier part of the portfolio, for example, with the IMGC936, the ADAM9 program where we are moving in the tumor types that have shown activity with checkpoint inhibitors, I think that creates the opportunity. So we're absolutely open to it. This is that we ran the experiment with mirvetuximab in ovarian cancer and for the reasons Anna identified, didn't see anything that made us to say this is a place we want to bet heavily.

Our next question comes from the line of Swayampakula Ramakanth from H.C Wainright.

This is RK from H.C. Wainwright. Most of my questions have been asked, just have a question on IMGC936. This is the ADAM9 targeting ADC that you have partnered with MacroGenics. Could you just give us some color as to the progress of the trial? And also, anything regarding timing for data release?

Yes. RK, we're delighted to have announced on our earnings call that we've dosed the first patients. And so the trial is on its way. It's a standard 3-plus-3 dose-escalation study and the beauty of ADAM9 is that it is highly expressed on multitude of solid tumors and not a normal tissue. So there is a nice differential there that is allowing us to go after nonsmall cell lung cancer, colorectal, pancreatic, gastric and triple-negative breast cancer. So we anticipate that a 3-plus-3 design shouldn't -- well, and when we have sufficient data, we look forward to sharing it.

Our next question comes from the line of John Newman from Canaccord.

So I just wondered if you could maybe elaborate a bit on how we should think about use of mirvetuximab longer term in the frontline, in combination in ovarian. I know obviously, that's down the road. There will be a bigger study. But just curious as to how you might get there if that will be a study that down the line ImmunoGen can put together and run that would maybe a study to look at with co-op groups. Just curious given the activity that you're seeing in combination with not just platinum but also -- also with Avastin.

Yes. So just to revisit the conversation we have with Jess. We are looking at combination regimens to expand the label that could include recurrent platinum-sensitive patients or these platinum agnostic patients that I described. And so I think that is the likely next step.

To get to a frontline indication, I think would likely involve a co-operative group study given the scale of that effort. So what we really want to do and for the next step in label expansion is to move into earlier lines and address some of these recurrent platinum-sensitive or platinum agnostic patients and also going right up to the top of the queue also started this IST in neoadjuvant and see what the impact is there. I can't tell you sitting here today what the exact path to registration would be for a neoadjuvant study. That's something we would need to think through. So I think in terms of near term from us, look for that patient segment where we're in later line platinum sensitive or platinum agnostic patients and stay tuned.

Thank you. At this time, I'm showing no further questions. I would like to turn the call back over to the team for closing remarks.

Great. Thanks very much. Well, we appreciate the interest today and look forward to seeing you all at ASH, and in the New Year and as we make further progress with the business. So thanks very much.

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