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Edited Transcript of IMGN earnings conference call or presentation 27-Jul-18 12:00pm GMT

Q2 2018 ImmunoGen Inc Earnings Call

WALTHAM Jul 30, 2018 (Thomson StreetEvents) -- Edited Transcript of ImmunoGen Inc earnings conference call or presentation Friday, July 27, 2018 at 12:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Anna Berkenblit

ImmunoGen, Inc. - VP & Chief Medical Officer

* David B. Johnston

ImmunoGen, Inc. - Executive VP & CFO

* Mark J. Enyedy

ImmunoGen, Inc. - President, CEO & Director

* Richard J. Gregory

ImmunoGen, Inc. - Executive VP & Chief Scientific Officer

* Sarah Cue Kiely

ImmunoGen, Inc. - IR & Corporate Communications Officer

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Conference Call Participants

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* Biren N. Amin

Jefferies LLC, Research Division - MD and Senior Equity Research Analyst

* Boris Peaker

Cowen and Company, LLC, Research Division - MD and Senior Research Analyst

* Earl DeSouza

H.C. Wainwright & Co, LLC, Research Division - Associate

* Jessica Macomber Fye

JP Morgan Chase & Co, Research Division - Analyst

* John Lawrence Newman

Canaccord Genuity Limited, Research Division - Principal & Senior Healthcare Analyst

* Kennen B. MacKay

RBC Capital Markets, LLC, Research Division - Co-Head of Biotechnology Research

* Tsan-Yu Hsieh

William Blair & Company L.L.C., Research Division - Senior Research Analyst

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Presentation

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Operator [1]

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Good day, and welcome, everyone, to this ImmunoGen Second Quarter 2018 Financial Results Conference Call. Today's call is being recorded.

At this time, for opening remarks and introductions, I would like to turn the call over to Sarah Kiely, Investor Relations and Corporate Communications. Please go ahead, ma'am.

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Sarah Cue Kiely, ImmunoGen, Inc. - IR & Corporate Communications Officer [2]

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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 second quarter 2018 operating results. This press release and the recording of the call can be found under the Investors section of our website at immunogen.com.

On the call today are our President and CEO, Mark Enyedy; our Chief Medical Officer, Anna Berkenblit; and our CFO, Dave Johnston. Rich Gregory, our Chief Scientific Officer, will join the team for the Q&A session. During today's call, we will highlight key recent accomplishments and review second quarter financial results and milestones for the remainder of the year.

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.

With that, I'll now turn the call over to Mark.

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Mark J. Enyedy, ImmunoGen, Inc. - President, CEO & Director [3]

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Thank you, Sarah. Good morning, everyone, and thank you for joining us today. During the second quarter, we continued our positive momentum, led by significant progress with our lead program, mirvetuximab soravtansine and strengthening our balance sheet.

As a reminder, we've set 4 strategic priorities for the business at ImmunoGen: first, completing the development and launching mirvetuximab for the treatment of women with ovarian cancer by 2020; second, accelerating our pipeline of novel IGN programs; third, building on our leadership position in ADCs through continued innovation; and finally, expanding the reach of that innovation and maintaining financial strength through high-value partnerships.

We achieved a number of important milestones supporting these objectives in the last several months. In April, we completed patient enrollment in FORWARD I, our Phase III registration trial for mirvetuximab, 2 months ahead of schedule, which nicely positions us for a readout on the primary endpoint in the first half of 2019. We also recently received FDA fast-track designation for mirvetuximab, which is an important step in our registration strategy.

In May and June, in conjunction with ASCO, we reported additional positive data from the Avastin and carboplatin cohorts of our FORWARD II study, which is evaluating multiple mirvetuximab combinations in earlier lines of treatment for ovarian cancer. We're encouraged by the growing body of data demonstrating favorable tolerability and activity across cohorts in FORWARD II, and we look forward to sharing initial data from the Keytruda expansion cohort at ESMO this October.

Finally, during the second quarter, we strengthened our cash position with an upsized and oversubscribed public offering of our common stock, adding approximately $163 million in net proceeds to our balance sheet. Importantly, this capital extend our runway well beyond the anticipated top line readout of the FORWARD I trial. So we're pleased to report the continued momentum with the business for the first 6 months of 2018.

With that, I'll turn the call over to Anna to review in more detail the progress we've made with the mirvetuximab program. Anna?

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Anna Berkenblit, ImmunoGen, Inc. - VP & Chief Medical Officer [4]

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Thank you. As Mark mentioned, we are pleased with the continued progress of our FORWARD I registration trial in platinum-resistant ovarian cancer and on track to report top line data from the trial in the first half of 2019.

As a reminder, the primary endpoint in FORWARD I is progression-free survival or PFS in the entire study population that includes both medium and high folate receptor alpha expressers as well as in the subset of patients with high folate receptor alpha expression. Based on the encouraging and consistent safety and activity profile observed in clinical studies to date, we believe mirvetuximab has the potential to displace chemotherapy as a single-agent treatment in the platinum-resistant setting.

In addition to our single-agent strategy, we are evaluating combination regimens to expand the eligible patient population and move into earlier lines of treatment for ovarian cancer in our FORWARD II trial. Today, I'll focus on the recently reported data from our FORWARD II study. This is our Phase Ib2 study of mirvetuximab in combination with Avastin or Keytruda in patients with folate receptor alpha positive platinum-resistant ovarian cancer. FORWARD II also enrolled a combination cohort with mirvetuximab and carboplatin, which laid the foundation for the triplet combination of mirvetuximab plus carboplatin and Avastin in patients with recurrent platinum-sensitive ovarian cancer that is now underway as part of FORWARD II.

We have established that full dose mirvetuximab can be combined safely with full doses of Avastin, carboplatin and Keytruda with favorable tolerability. At ASCO this June, we presented data demonstrating encouraging activity from the expansion cohort, evaluating mirvetuximab in combination with Avastin in over 50 patients with folate receptor alpha positive platinum-resistant ovarian cancer. The combination was well tolerated, and observed adverse events were consistent with the known safety profiles of each agent.

The overall population received a median of 3 and up to 8 prior lines of therapy with 58% of patients having received prior Avastin and 29% of prior PARP inhibitor. For the 54 patients evaluable for response, the confirmed overall response rate or ORR was 43% with a median PFS of 7.8 months. Importantly, in the FORWARD I matched subset of 23 patients with medium or high folate receptor alpha expressions and 1 to 3 prior lines of therapy, the confirmed ORR was 48% with a median PFS of 9.9 months and a median duration of response of 10.6 months.

We are particularly excited about the potential for the combination in this subset of patients, which is the same as that of our FORWARD I monotherapy study. As a reminder from ASCO last year, the pooled analysis in this population showed a median PFS of 6.7 months and median duration of response of 5.8 months with mirvetuximab as a single agent. So the combination appears to provide improved benefits, manifested by longer PFS and duration of response.

We were also pleased to provide mature findings from 17 evaluable patients with platinum-sensitive recurrent ovarian cancer from the dose-escalation cohort evaluating mirvetuximab plus carboplatin, which had been accepted for publication in Gynecologic Oncology. Initial data presented at ASCO in 2017 showed a 65% confirmed response rate with a median PFS of 12.1 months. With longer follow-up, the confirmed response rate is now 71% with a median progression-free survival of 15 months. Of note, in the subset of 10 patients with medium or high folate receptor alpha expressions, the confirmed ORR was an impressive 80% with a median PFS of 15 months. Importantly, this combination continues to display favorable tolerability.

Taken together, the encouraging findings from both the Avastin and carboplatin combination cohort support the ongoing triplet expansion cohort that I mentioned earlier, evaluating mirvetuximab plus Avastin and carboplatin in patients with recurrent platinum-sensitive disease.

Another combination assessment looking at mirvetuximab plus Keytruda is ongoing. You'll recall that we presented encouraging initial findings on 14 patients receiving this combination in March at SGO. And we will report additional data on 46 additional patients, 35 of whom have medium or high folate receptor alpha expression from the expansion cohort at ESMO this October.

In closing, we've made significant progress with our mirvetuximab clinical program. The encouraging data we have generated from FORWARD II so far this year will culminate with data from more than 100 patients who have received mirvetuximab in combination with Avastin and Keytruda by year-end. We believe this growing body of clinical evidence supports mirvetuximab's expanded use in ovarian cancer.

Now I'll turn the call over to Dave to review our financials.

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David B. Johnston, ImmunoGen, Inc. - Executive VP & CFO [5]

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Thanks, Anna. Our financial results were detailed in this morning's press release, so I'll just review the highlights.

As Mark mentioned at the beginning of the call, one of our core objectives is to maintain our financial strength to support the broad development of mirvetuximab; our earlier-stage IGN programs; our leadership position in ADCs; and our high-value partnerships. In June, we completed a successful offering, have added net proceeds of approximately $163 million to our balance sheet. With this influx, we ended the second quarter with approximately $345 million in cash and cash equivalents.

Revenues for the second quarter were $9.3 million, which were largely noncash, as described in the press release. Operating expenses in the second quarter were $48 million, and this included approximately $39 million of research and development expenses, driven by clinical trial costs largely related to the continued advancement of FORWARD I. Operating expenses in the second quarter also included a $700,000 restructuring charge due to the workforce reduction related to the decommissioning of our Norwood facility as well as G&A expenses.

We're updating our guidance for the remainder of 2018. We expect revenues to be between $60 million and $65 million, which is no change from prior guidance. We expect our operating expenses to be between $215 million and $220 million, which is about $15 million higher, primarily due to accelerated clinical trial costs. And we expect our cash at year-end to be between $265 million and $270 million compared to our previous guidance of between $115 million and $120 million, reflecting the recent fundraising as well as the change in operating expense guidance.

We continue to operate with financial discipline, focusing our resources on advancing mirvetuximab towards the market. Our financial position is strong with a cash runway that extends at least a year beyond the readout of the Phase III FORWARD I trial expected in the first half of 2019.

So with that, let me now hand the call back over to Mark.

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Mark J. Enyedy, ImmunoGen, Inc. - President, CEO & Director [6]

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Thanks, Dave. The first half of 2018 has been highly productive for the company, and we look forward to a number of important milestones for the remainder of the year.

As Anna highlighted, we will report data from the mirvetuximab and Keytruda expansion cohort at ESMO in October. Our IGN pipeline is also progressing with our Phase I studies of IMGN779 and IMGN632 in hematologic malignancies ongoing. We expect to share data from these programs at the ASH Annual Meeting in December, and we also expect to initiate IND-enabling activities for our novel ADAM9 program in collaboration with MacroGenics before the end of the year.

In short, we continue to move through 2018 with a focus on execution and are encouraged about the evolution of ImmunoGen and the progress we are making with our pipeline.

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

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Questions and Answers

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Operator [1]

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(Operator Instructions) At this time, we do have several callers in the queue. (Operator Instructions) We'll take your first question from Biren Amin from Jefferies.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [2]

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Maybe if I could just start with the FORWARD I study and just ask on how the alpha is split. I think Anna mentioned that PFS -- you're looking at medium and high as well as high alone. Will you be evaluating the high alone first? Is it a hierarchical? Or will both subsets be evaluated? And how is the alpha split across both subsets?

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Anna Berkenblit, ImmunoGen, Inc. - VP & Chief Medical Officer [3]

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Thanks, Biren. So we are looking at progression-free survival in the intent-to-treat population, which is the medium and high group as well as the high subset. We are using what's called the Hochberg procedure. So this is not hierarchical testing, but rather we test simultaneously in the ITT and the high subset. If the P value is less than 0.05 in both the ITT and the high subset, we claim success in both. If on the other hand, the PFS is greater than 0.05 in one, it needs to be less than 0.025 in the other.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [4]

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Got it. And then just on FORWARD I. Now that the trial is fully enrolled, the control arm allows for investigator's choice of 3 different chemotherapy agents. Can you talk about the split across those 3 that you've enrolled in the control arm?

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Anna Berkenblit, ImmunoGen, Inc. - VP & Chief Medical Officer [5]

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So the investigator choice options include paclitaxel, Doxil and topotecan, and patients are allowed 1 to 3 prior lines of therapy. What I can tell you at this point is that we have enrolled patients on all 3 investigator choice options. There's a nice distribution as we would have anticipated.

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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [6]

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Got it. And then maybe one last question. As we're anticipating data with the mirv-Keytruda combo at ESMO, what are next plans for this regimen? I'm sure you've got some insights into the data. So can you talk a little bit about how you plan to develop this combination?

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Anna Berkenblit, ImmunoGen, Inc. - VP & Chief Medical Officer [7]

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Sure. So we enrolled the expansion cohort based on the promising data we saw in escalation. Enrollment in the expansion cohort completed rather recently. So the data that we will see at ESMO will be the initial efficacy data from an expansion cohort with 46 patients overall, 35 of whom have medium to high folate receptor alpha expressions. With this, we should have a reasonable initial read on objective response rate, but it's a bit early for us to anticipate meaningful data from a duration-of-response perspective or a PFS perspective. That being said, if the data for the expansion cohort looks reasonably similar to what we saw in escalation, that would be quite encouraging. And if the data continue to hold up with longer follow-up, that would certainly prompt us to continue our conversations with Merck and, potentially, to engage the FDA regarding breakthrough status and pathway toward accelerated approval based on a single-arm study.

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Operator [8]

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We'll hear next from John Newman from Cannacord.

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John Lawrence Newman, Canaccord Genuity Limited, Research Division - Principal & Senior Healthcare Analyst [9]

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Just had a question on the development of the mirvetuximab plus Avastin combination. You've recently started looking at the triplet, where you're combining mirv plus Avastin plus carboplatin as well as the continued Avastin plus mirv arm in FORWARD II. I'm just curious, long term, could you walk us through how you're thinking about generating the data in order to get that combination in the hands of physicians and utilize that in patients? I'm curious if you're thinking about just generating enough data so that doctors can potentially use it off-label or if you're thinking about something else. And I also wonder if you could just comment on the recent MANGO -- MITO/MANGO data at ASCO and how that should help long term.

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Anna Berkenblit, ImmunoGen, Inc. - VP & Chief Medical Officer [10]

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Thanks, John. So we initially explored 2 doublets, mirvetuximab plus Avastin and mirvetuximab plus carboplatin. Based on the promising safety and antitumor activity from both of those combinations, we are now enrolling a triplet cohort with full dose mirv, full dose carboplatin, full dose Avastin. And as you point out, after completion of the carboplatin component of the regimen, we continue not just the Avastin but also the mirvetuximab out back as maintenance therapy. And this is in recurrent platinum-sensitive disease. If these data are as encouraging as we hope they will be, based on the doublet data we've generated thus far, we have a couple options, John. One would be really depending on the level of evidence and the robustness of the efficacy signal. One would be to generate sufficient data for compendia listing and/or the other would be to pursue a much larger program with registrational intent, which would be a randomized Phase III study. We're going to have to look at the data to really clearly identify what we would consider proof of concept and go criteria to proceed for the next study. But right now, our focus is on rapidly enrolling the triplet single-arm study to get safety and initial efficacy data. Now mind you, the progression-free survival for this cohort should be pretty long on the order of -- I don't know. It's 15 months with just with the carboplatin doublet. So I wouldn't be surprised if it would be longer than that. So first data will be available probably sometime next year. Oh, and your MITO/MANGO question. So MITO/MANGO was a study presented at ASCO demonstrating that, in recurrent platinum-sensitive disease, retreatment with Avastin-based combination therapy is just as effective as patients who had gotten Avastin after an initial non-Avastin-containing regimen. This is important because Avastin is now approved not just in platinum-resistant disease and recurrent platinum-sensitive disease, but as of June, also in the front line setting in the U.S. And therefore, the MITO/MANGO Phase III data supports the use of Avastin after Avastin in the recurrent platinum-sensitive setting. I wouldn't be surprised if we find that Avastin after Avastin use in the platinum-resistant setting is also effective. Therefore, our mirvetuximab plus Avastin data that we presented at ASCO has wide implications for repeated use in ovarian cancer.

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Operator [11]

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Boris Peaker from Cowen.

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Boris Peaker, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [12]

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Let me maybe just start -- continue discussion initially on the combo studies. I mean, you mentioned that there are several options that you're considering. You're waiting on some data to mature before deciding whether it's compendia listing strategy or randomized Phase III study. I'm just curious, if you -- is there a kind of a timeline where you think -- kind of draw in the sand right now where you think you have the answer to that or potentially commence such study if you decide to go the randomized Phase III route?

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Mark J. Enyedy, ImmunoGen, Inc. - President, CEO & Director [13]

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So Boris, the data we'll have at ESMO will certainly cover the initial responses in this expansion cohort with Keytruda. And so our expectation is that in the first quarter, we'll have a perspective on the durability of those responses that may support an approach to FDA for that combination. Separately, the triplet combination, we -- I think we'll have an initial view, I would say, in the -- certainly in the first half of next year with respect to the safety and, again, the initial responses that we're seeing in those patients. And so I think both of those events tell us that in the first half of next year, we'll have a reasonable perspective on both of those cohorts. Anna, did you want to add anything to that?

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Anna Berkenblit, ImmunoGen, Inc. - VP & Chief Medical Officer [14]

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No, I think that's exactly right. Thank you.

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Boris Peaker, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [15]

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Got you. And my second question is maybe with the ESMO data coming up. Could you set maybe some expectations of what good data would be?

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Anna Berkenblit, ImmunoGen, Inc. - VP & Chief Medical Officer [16]

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Sure. So in recurrent ovarian cancer with 3 to 4 prior lines of therapy, PARP got their initial accelerated approval in the subset of patients with BRCA mutations based on a response rate of around 30% and a duration of response of about 8 months. So that applies to the BRCA mutant subset. BRCA wild type patients really have no approved therapies in that setting. So if our combination provides sort of that level of efficacy from the response rate and duration of response perspective, we think that, that would be a meaningful benefit for patients, and we would engage FDA in conversations around that.

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Operator [17]

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We'll hear next from Jessica Fye from JPMorgan.

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Jessica Macomber Fye, JP Morgan Chase & Co, Research Division - Analyst [18]

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I think following up on [Boris'] question and the prior one, just setting expectations for ESMO. I think you mentioned duration-of-response data could be a little immature. Can you remind me when the last patient we'll see at ESMO was enrolled and what range of follow-up we could expect on the new patients? And then can you also talk a little bit about whether there's data on folate receptor alpha having prognostic value, i.e., do highs tend to do better or worse than lows in the absence of an ADC like yours? And lastly, can you comment on how many dose levels you've moved through for 632 at this point?

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Anna Berkenblit, ImmunoGen, Inc. - VP & Chief Medical Officer [19]

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Okay. So the last patient in on the Keytruda arm was after ASCO. So it's going to be a relatively immature data set. I do believe that we will have overall response rate for the entire cohort. But duration of response, you may remember that you only start counting the beginning of duration of a response once the patient responds. So it might take a few months for patient to have a response and then the clock starts ticking. So that's why I want to caution us that we may have initial overall response rate. But that may even improve over time with longer follow-up because, again, we only report confirmed responses, which require 2 scans. For your second question, there's been a lot of small papers published, retrospective papers published, on folate receptor alpha as a prognostic factor, and they're pretty much all over the map. There are some papers suggesting that folate receptor alpha is a poor prognostic factor with standard-of-care options. Therefore, the high folate receptor alpha expression patients who appear to do best with mirvetuximab may actually do worse with standard-of-care chemotherapy. But we don't know that, and we won't know that until we have the results of our randomized Phase III study. There are also other studies suggesting that there's no impact on overall survival with folate receptor alpha. So again, we're excited to see the data from our Phase III trial which will answer that question. Moving on to and switching gears to our hem programs. IMGN632 is our CD123-targeted antibody-drug conjugate, and we started enrolling the dose-escalation Phase I study in January of this year. We are moving as quickly as possible in the 3 plus 3 design, and we will share all the data that we have at ASH.

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Operator [20]

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We'll hear next from Kennen MacKay from RBC Capital Markets.

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Kennen B. MacKay, RBC Capital Markets, LLC, Research Division - Co-Head of Biotechnology Research [21]

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I had a couple more questions for Anna here. I'm trying to understand the upcoming ESMO data set. I wanted to follow up on the expectations for the PD-1 combo questions again and to get a better understanding sort of what kind of duration we could get on the sort of overall 46 patients that will get there and the 35 in sort of medium, high. Should we be expecting like average of sort of 3 to 5? And where will we see sort of duration-of-response curves and those that are evaluable or PFS curves in those that are evaluable? And then I had 2 very quick follow-ups.

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Anna Berkenblit, ImmunoGen, Inc. - VP & Chief Medical Officer [22]

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Okay. So when I addressed Jess's question, I pointed out, Kennen, that duration of response, you can only start measuring it once a patient is in response, and it may take a few months to -- until you have a response. And then duration of response isn't measured until the patient progresses. In other words, the patient would be censored during the analysis, so you don't have like the endpoint. So I really want to manage expectations here. We don't anticipate having meaningful duration-of-response data at ESMO, and we're not going to report it on the first half of the cohort, for example because that could introduce bias. This will be our initial data, hopefully confirming the safety of the combination as well as an initial peak into efficacy. We look forward to presenting updated mature data from the cohort next year.

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Kennen B. MacKay, RBC Capital Markets, LLC, Research Division - Co-Head of Biotechnology Research [23]

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Okay, very clear. And then 2 quick follow-ups. One was if you had thought about doing a triplet combo with pembro. The initial pembro combo data at SGO is obviously very early, but (inaudible), this actually looks like maybe better data than the Avastin combo data. And then just a quick follow-up on the prior questions surrounding a combination path forward through either compendia listing as opposed to randomized Phase III route. I'm just wondering if there was any precedent for that. For instance, with 2 experimental therapies that aren't yet approved in a specific indication, getting approval or through either an accelerated approval together or getting a compendia listing?

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Anna Berkenblit, ImmunoGen, Inc. - VP & Chief Medical Officer [24]

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Okay. So let me start with the triplet for mirv, carbo, pembro. We would love to do that triplet, particularly because pembrolizumab is now approved with carboplatin and pemetrexed in [unselected] lung cancer patients in the first line setting. So I could imagine that carboplatin plus mirvetuximab plus pembrolizumab for folate receptor high tumors could be a very exciting triplet. All I can say is we have a drug-only collaboration with Merck for the ongoing Keytruda trial. And as the data from the doublet evolve and also our triplet data with Avastin evolve, I hope we have continued conversations about how to advance mirvetuximab plus Keytruda in a variety of settings and combinations. Regarding your second question about the potential for an approval of novel-novel therapies based on single-arm data. Our strategy really is to get mirvetuximab approved in the platinum-resistant setting and then add on to it with Keytruda, and so that's really where we're headed. There are precedents that are out there. For example, combining a RAS/RAF/MEK inhibitor combination without individual agents being approved. But those were building on the body of data for those pathways with prior single-agent approval. So it's not necessarily the best precedent. That being said, FDA is becoming more flexible in terms of how they are thinking about accelerating drug development. So all I can say is if our data hold up, it will be worth having a conversation with the regulators about what level of evidence we would need, how many patients' worth of data to support an accelerated approval.

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Kennen B. MacKay, RBC Capital Markets, LLC, Research Division - Co-Head of Biotechnology Research [25]

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Got you. And then just -- that was very clear. Just a quick follow-up on that point. You'd referenced sort of the bar for the PARP inhibitors gaining an accelerated approval there, and that was requiring sort of just over maybe 100 patients or so with the response rate and duration that you had mentioned. Is that something you think could be the case for like a pembro-mirv combo? And again, it's a slightly different population because here, you may not have the requirement for a biomarker, which the PARPs had, which maybe makes it sort of a smaller market and that -- on lower bar, potentially on lower bar for approval in the eye of the FDA.

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Anna Berkenblit, ImmunoGen, Inc. - VP & Chief Medical Officer [26]

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Well, to be clear, we're focused on the medium to high folate receptor alpha patients, so we would have a biomarker. But still, that encompasses 60% of the ovarian cancer population as opposed to the 20% with BRCA mutations. So again, with mirv plus Keytruda, there is a wealth of data now for Keytruda monotherapy in heavily pretreated patients, and we also have a wealth of data for mirvetuximab in more heavily pretreated patients. So again, I think the combination could benefit folate receptor alpha, medium to high positive patients, BRCA wild type with 3 or 4 prior lines of therapy.

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Operator [27]

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We'll hear next from Debjit Chattopadhyay from H.C. Wainwright.

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Earl DeSouza, H.C. Wainwright & Co, LLC, Research Division - Associate [28]

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I'm in for Debjit, Earl DeSouza. So 2 questions on our side. First, given a slew of setbacks for ADCs culminating with the Amgen decision to stop its BCMA ADC program last night, how does this kind of change the environment for ADCs? And how is ImmunoGen differentiating results? Question two, post-ESMO, which is the most logical registrational study for mirvetuximab? And do you wait for the FORWARD I to read out first or, given your balance sheet, going to proceed early in 2019?

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Richard J. Gregory, ImmunoGen, Inc. - Executive VP & Chief Scientific Officer [29]

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So it's Rich Gregory. I'm maybe taking the first one about the environment around ADCs. Actually, I think it's a rather positive environment at the moment. If you look at the last year, we had 2 additional approvals in this space. There's multiple programs such as Immunomedics' breast cancer drug, you're looking at the Daiichi HER2 new drug and mirvetuximab. I think there's plenty of examples of what appear to be quite successful ADCs in late-stage development right now, and there's about 70 programs in the clinic at the moment. So I look at this as a moment where the ADC field is -- as usual, drugs will fail, but it is actually on an accelerating curve. And where we think we could differentiate ourselves is, first, we have a wealth of experience. We kind of know what payers like, so we have a good sense of what we need to do to be better. And I think mirvetuximab is a great example of the thought that went into an ADC, and we're trying to apply that same level of rigor to all the additional programs we're bringing forward and differentiating based upon a lending payload, PK and pharmacodynamics in a way that's very thoughtful for each additional new target. So I think if you look at us, we're the most experienced ADC company out there. Perhaps Seattle can claim the same thing. But we have, I think, the right set of people and experience to succeed in this field.

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Anna Berkenblit, ImmunoGen, Inc. - VP & Chief Medical Officer [30]

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And I'll take your second question regarding the next registrational study and would we do it before or after FORWARD I reads out. You may recall that we will have top line data from FORWARD I first half of next year. So our intent for the next registrational study is, if the Keytruda combination data hold up, to engage FDA on a conversation and then pursue an accelerated approval with that combination as our next approval and label expansion.

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Operator [31]

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(Operator Instructions) We'll hear next from Andy Hsieh from William Blair.

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Tsan-Yu Hsieh, William Blair & Company L.L.C., Research Division - Senior Research Analyst [32]

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I just [have] one, and it has to do with manufacturing. I believe, Mark, you mentioned some commentary about the manufacturing switching sites to a third party. So if I understand it correctly, the clinical trial supply and the commercial supply will be made by different parties. Would you mind reminding us what studies do you have to do to make FDA comfortable with the smooth transition and perhaps update us in terms of the scale-up efforts for your third-party partner?

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Mark J. Enyedy, ImmunoGen, Inc. - President, CEO & Director [33]

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Yes, sure. So thanks for the question. So first, there's been no change in the manufacturers for mirvetuximab. So keep in mind that there are 3 components to an antibody drug conjugate. Antibody, in this case, is manufactured by Boehringer Ingelheim. The linker is manufactured by Sigma-Aldrich, and then the payload is manufactured by Teva-Sicor. And then each of those 3 components is shipped to a company called BSP, that's really the leading conjugator in the world for ADCs, to produce the drug substance and drug product. And so all of those manufacturers have been in place for years at ImmunoGen. So there is no change in the production. And the commercial scale product was used in the majority of patients in the Phase III study. So we don't anticipate any regulatory comparability issues with respect to the BLA for mirvetuximab. I don't know, maybe there was some confusion about the decommissioning of our Norwood facility and transitioning out of there. We used Norwood for many years to produce early clinical supplies of drug substance, and we're decommissioning that plant to last batches of -- some of our early stage clinical material being produced as we speak. And we're very much on track to decommission that facility by the first quarter. And the various components, again, are manufactured elsewhere, and the conjugation production will be transferred to BSP. But again, those are the earlier-stage programs, not mirvetuximab.

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Operator [34]

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And at this time, there are no additional callers in the queue. I'd like to turn the conference back over to your host for any additional or closing comments.

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Mark J. Enyedy, ImmunoGen, Inc. - President, CEO & Director [35]

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Great. Well, thanks very much for your interest today. We look forward to continuing to update you on our progress and seeing you all at ESMO. Thanks again.

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Operator [36]

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That does conclude today's teleconference. We thank you all for your participation. You may now disconnect.