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Good day, everyone and welcome to the First Quarter 2019 Conference Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Sarah Kiely, Director of Investor Relations and Corporate Communications. Please go ahead.
Good morning and thank you for joining today’s call. Earlier today, we issued a press release that includes the summary of our recent progress and first quarter 2019 financial results. This press release and a recording of the call can be found under the Investors & Media section of our website at immunogen.com.
On the call today are Mark Enyedy, our President and CEO; and Anna Berkenblit, our Chief Medical Officer. Rich Gregory, our Chief Scientific Officer; and Dave Foster, our Chief Accounting Officer, will join the team for the Q&A session.
During today’s call, we will discuss recent progress, review our first quarter financial results and highlight 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.
With that, I will turn the call over to Mark.
Thanks, Sarah. Good morning, everyone and thank you for joining us today. In early March, we announced top line results from the Phase 3 FORWARD I study of mirvetuximab in platinum-resistant ovarian cancer patients. While we were disappointed that the trial did not meet its primary endpoint, we were encouraged to see a consistent efficacy signal in the pre-specified subset of patients with high folate receptor alpha expression. Specifically, in comparison to chemotherapy, we observed more than twice the response rate and more durable responses with mirvetuximab in this patient population. In addition, progression-free and overall survival, were longer in the mirvetuximab-treated patients. We believe this consistent efficacy signal, coupled with differentiated safety and tolerability demonstrate a favorable benefit risk profile for mirvetuximab. With the benefit of these additional analyses of the data from FORWARD I and input from our clinical and regulatory advisors, we will be meeting with the FDA this quarter to discuss the potential path to registration for mirvetuximab monotherapy in the FR alpha high population. We look forward to updating you on the outcome of those discussions.
Moving to our FORWARD II trial, we have generated promising data with mirvetuximab combination regimens with the goal of expanding our market opportunity for mirvetuximab in the earlier lines of therapy. Anna will update you on our progress and upcoming data from this study. In addition, we are evaluating combination approaches as an independent avenue to support a label for mirvetuximab. Looking beyond mirvetuximab, we are advancing our novel IGN programs, IMGN632 and IMGN779, in hematological malignancies. We continue to enroll patients in expansion cohorts of the Phase 1 study of IMGN632 in patients with relapsed or refractory AML and BPDCN, and we are nearing completion of the crew for our Phase 1 study of IMGN779 in AML patients, with data expected for both studies later this year. Separately, we are on track with IND-enabling activities for IMGC936, our novel ADAM9-targeting ADC that’s being developed in collaboration with MacroGenics, with a submission plan for 936 before the end of this year.
Turning to our financial results, which were detailed in the press release we issued this morning. ImmunoGen is in a strong financial position with approximately $270 million on the balance sheet, providing flexibility for continued investment in our portfolio. The previously announced operational review of the business to extend our cash runway is ongoing, and we expect to announce the results of this effort following our engagement with the FDA.
Regarding our first quarter financials, we generated $8.6 million in revenue, which included $8.5 million in noncash royalty revenues related to Kadcyla sales. Our operating expenses for the first quarter were approximately $50 million compared with $57 million for the same quarter in 2018. The decrease was primarily related to lower clinical trial cost in the current period compared to the prior year when these expenses were driven by accelerating patient accrual in FORWARD I. As previously noted, we ended the quarter with approximately $270 million in cash and cash equivalents on the balance sheet. We will provide an update on our 2019 financial guidance following the completion of our operational review.
With that, I’ll turn the call over to Anna to review our pipeline progress in more detail. Anna?
Thanks Mark. As mentioned, we have recently announced top line results from the Phase 3 FORWARD I study of mirvetuximab soravtansine. While we are disappointed that this study did not meet its primary endpoint, we remain encouraged by the consistent signals of efficacy in the prespecified high folate receptor alpha subset. Additional analysis we subsequently conducted reinforced the consistency of the efficacy signals we initially observed in the top line results.
For the safety perspective, mirvetuximab is well tolerated, with fewer Grade 3 or greater adverse events, dose modifications and treatment-related discontinuation than chemotherapy. For those patients with high folate receptor alpha expression, we believe these data demonstrate a favorable benefit risk profile in platinum-resistant ovarian cancer, a population that still has a high unmet need, highlighted by recent disappointment from Phase 3 trials of a checkpoint inhibitor and a novel chemotherapy.
We have shared the FORWARD I data with mirvetuximab experienced investigators and with additional clinical and regulatory advisers. We continue to hear that physicians want to be able to give mirvetuximab to their folate receptor alpha high ovarian cancer patients with platinum-resistant disease who need more effective and well-tolerated treatment option. In other tumor types, such as colon cancer and multiple myeloma, we know that patients live longer with the availability of additional effective lines of therapy. Within this context, we look forward to discussing with regulators a path forward for approval of mirvetuximab as a monotherapy. We are planning to submit the data to ESMO and present the data later this year.
Turning now to combinations, the tolerability profile of mirvetuximab, particularly the lack of myelosuppression lends itself to combination, which we are advancing in the FORWARD II trial. Our goal remains to establish mirvetuximab as the combination agent of choice in ovarian cancer, supporting use in earlier lines of therapy. In FORWARD II, we are looking at mirvetuximab doublets as well as a triplet combination cohort that is evaluating mirvetuximab plus carboplatin and Avastin in patients with recurrent platinum-sensitive disease. We will present mature data from the Avastin doublet cohort in platinum-resistant ovarian cancer at ASCO. Also at ASCO, Dr. Christie will be presenting initial data from her mirvetuximab plus gemcitabine combination trial through the NCCN. For the ongoing triplet cohort, we are planning to submit initial safety and efficacy data to ESMO. And as Mark noted, we continue to enroll patients in the second FORWARD II Avastin cohort, which evaluates mirvetuximab in platinum-agnostic ovarian cancer. This platinum-agnostic population includes the growing number of patients who progress after PARP inhibitor maintenance therapy.
Moving to our earlier stage portfolio, our novel IGNs, IMGN632 and IMGN779, these are being evaluated for the treatment of hematologic malignancies with a focus on AML and BPDCN. As a reminder, IMGN632 is a CD123-targeting ADC that deploys our most potent IGN payload, while IMGN779 is our CD33-targeting ADC. Patient enrollment continues in our expansion cohort for the Phase 1 study of 632 in patients with relapsed or refractory AML and BPDCN with additional sites being opened in Europe as well as in the Phase 1 study of 779 in AML.
We were also pleased to present encouraging preclinical activity in models of non-small cell lung, gastric and colorectal cancers for our newest candidate, IMGC936, at the AACR annual meeting. In total, we presented at 11 posters at AACR, showcasing our most recent ADC advancement and further demonstrating continued innovation from our research platform. As Mark noted, we expect to file an IND for IMGC936 before the end of the year. Looking ahead, we plan to present updated IMGN632 data with additional AML and BPDCN patients and establish the recommended Phase 2 dosing schedule this year. We will initiate combination studies with 632 and establish the recommended Phase 2 dose for IMGN779.
With that, I will turn the call back over to Mark.
Thanks, Anna. As we move forward in 2019, we remain focused on executing our near-term priorities, which include: first, working with the FDA and EMA to determine a potential avenue to approval for mirvetuximab as monotherapy and platinum-resistant ovarian cancer; generating additional combination data to support market expansion and as an independent path to a label in ovarian cancer; continuing to advance our portfolio of next-generation ADCs; and finally, completing a review of our operations with a goal of extending our cash position. I want to remind everyone that while we have disclosed top line results from FORWARD I, we are not in a position to discuss full details of the study today in order to preserve the opportunity to present the data at a future medical meeting.
With that, we will open the line for questions.
Thank you. [Operator Instructions] Our first question today comes from John Newman from Canaccord.
Hey, guys. Good morning. Thanks very much for taking my questions. So, Mark and Anna, just curious in terms of the interactions that you plan to have with that European regulator, I just wonder if you would expect that the approach and considerations there would be similar to the FDA or just wondered if perhaps there would be any differences in the way that they might think about things going forward? Thanks.
Yes. So those agencies have somewhat different approaches to assessing circumstances like we find ourselves. And so the FDA has a very clear avenue related to, in our case, subpart E approvals for biologics for considering for accelerated approvals based on surrogate endpoints. And while there is a similar provision called the conditional marketing authorization for the EMA, the approach to the agencies differs to some degree. And so the implications for us, as it relates to that, is one of timing. And so we are engaging with Europe, but the time line there will be longer than our engagement with FDA. Beyond that, they also tend to look at the data differently and surrogate endpoints can differ the approach to even full approval can differ. So for example, FDA is perfectly happy with progression-free survival as an endpoint for full approval. In Europe, beyond PFS, they often look for patient-reported outcomes, for example, to support a PFS finding. And so well, as I said, the general approach, the broad framework are analogous that the details do become important.
Okay, great. Thanks. And then maybe just one question for Anna, obviously, I know that you can’t discuss details on the data at this time, but just wanted if you can give us a sense just broadly speaking where the survival events sort of fell out in the initial report, just curious if you would say that there were a meaningful number of survival events at that time? Obviously, we will get the full data at later time point. Thanks.
Right. So as a reminder, overall survival in platinum-resistant ovarian cancer is somewhere between 11 and 14 months that really highlights the dire situation that these patients are in. You may recall that we completed enrollment in the trial last year in the March/April timeframe. And the data cut that we used for the primary analysis was in January of this year, so approximately 9 months in between. So you can imagine, especially with the very brisk enrollment toward the end that there are many patients who have not yet really had the opportunity to potentially live past that median endpoint, if you will, the median time for overall survival. That being said, we enrolled patients over a 15-month period. And so what I would say is the hazard ratio that we reported in the press release with a hazard ratio of 0.62 and a p-value of 0.033 was based on a reasonable number of events. However, the data were immature and we continue to follow patients for overall survival, which is a key secondary endpoint.
Great. Thanks so much, guys.
Moving on, our next question comes from Andy Hsieh from William Blair.
Thanks for taking my questions. I am just wondering from a timing of various scenario perspectives I am just wondering if you kind of lay out, let’s say, in the event of a positive FDA meeting, when – how long would it take for the application to go in. I realize that you have fast-track designation, so that means you can kind of start parts of that and get the ball start rolling. And in the negative event, how soon can we start the second Phase 3 study?
Yes. So in the event of a positive FDA meeting, we would expect to be able to file the BLA before the end of the year. In terms of initiating a confirmatory study, some of that’s going to depend on the dialogue that we have with the agency and what their perspective is vis-à-vis both the initial application and then what their requirements are for full approval. And so it’s a little bit hard to time that, Andy, at this point. I think that should wait the outcome of the discussion that we have with them.
Okay. Yes, no, it’s fair enough. I understand. And I guess based on your discussions with various experts, regulatory experts, clinical experts, maybe on a high level, what are some aspects these experts like and what are some aspects that cause maybe some hesitation in terms of recommending going forward, just curious if we can kind of talk at a very high level about those?
Sure. The outside consultants that we have engaged with Andy include clinical drug development experts and regulatory experts. And I will start with the things that we consistently hear are that they are impressed with the consistency of the efficacy signals that we see in the high subset, the high FR alpha subset, coupled with the favorable tolerability and differentiated safety profile. So, when you package those together, there is a favorable benefit risk we believe in this high FR alpha subset. As a reminder, we went head-to-head against active chemotherapy that physicians know how to use. Even with that, we had fewer discontinuations due to drug-related adverse events. And also as a reminder, we didn’t get this efficacy signal based on adding to another agent so that there is a toxicity price to pay. So really from a benefit risk perspective, it’s clear that the high subgroup does have a favorable benefit risk. Where the conversation then goes so is how to interpret the data from the Phase 3 trial given that we did not meet the primary endpoint. And so given the context in which we generated these data in platinum-resistant patients who need more effective and well-tolerated therapies, we are looking forward to discuss the data with the regulators to discuss the path forward.
I see. Okay, that’s super helpful. Thank you very much for taking my questions.
Moving on, we will hear from Kennen MacKay from RBC Capital Markets.
Hi this is Kennen. Thanks for taking the question. Anna, can you help us maybe understand the additional efficacy analyses that you’ve mentioned at least things like time to second progression, or what should we be thinking about there? You mentioned those were encouraging. And then secondly, it’s very clear that you’re taking an approach in the EMA aiming for conditional approval. To be clear in the U.S., are you taking the same approach with the FDA aiming for accelerated approval? Or is full approval potentially on the table? And is this something that has to be sort of declared ahead of the end of Phase III meeting when you discuss the path forward to sort of set the agenda for the meeting? Thanks.
So, in terms of the additional efficacy analyses, Kennen, the top line data that we reported March 1 were really the key efficacy analyses that were prespecified in the statistical analysis plan. However, there were many other efficacy analyses that were prespecified in the statistical analysis plan, and so we have now gotten those data as well. Specifically, around PFS 2, our progression-free survival 2, which is similar to what you were describing, we were also looking at CA 125 responses, also looking at patient-reported outcome data, also looking at prespecified subgroup analysis within the ITT and the high FR alpha subset, so looking at 1 to 2 versus 3 priors, looking at additional patient subsets. And again, the data are consistent. So, this is why we believe that the data initially presented with the top line data are really indicative of a consistent efficacy signal in the high FR alpha subgroup. Turning to your question around accelerated approval and conditional marketing authorization, we believe that both of those are the reasonable path forward for discussion with the regulators in the U.S. and Europe, respectively.
That’s all. Thanks for answering the question.
Our next question is from Michael Schmidt from Guggenheim.
Hi guys. Good morning. Thanks for taking my questions. Maybe just a follow-up on the just the comment just now on the additional analysis, it was interesting that the comments you made around OS and I was just wondering if you would be doing another OS data analysis before heading to the FDA and/or whether some of that will be included in the ESMO presentation? And then, I had a follow-up as well.
So, we are continuing to follow patients for overall survival. And they’ve been consented for that type of follow-up, and we are doing that.
So, you will have more mature OS data for your FDA meeting?
We will be providing a data package to FDA that will facilitate the most productive discussion regarding the potential path forward.
Okay, very helpful. Thanks. And then just looking at some of the other data presentations that are coming up, you mentioned ASCO and then potentially ESMO. Could you just give us some more details with respect to what expectations are for those updates in terms of patient numbers, for example, and interpretation of those data?
Sure. So, at ASCO, we will present mature data from our initial mirvetuximab plus bevacizumab or Avastin cohort. You may recall that last year at ASCO, we presented data on 54 patients from a trial that was still enrolling. Now we have complete data from 66 patients. They all have platinum-resistant disease. And so, we will be presenting mature, safety and efficacy data from that entire cohort. Turning to ESMO, we are in the midst of finalizing abstract for submission, both for FORWARD I and for the triplets. The triplet is carboplatin plus mirvetuximab plus Avastin, and we completed enrollment in that cohort at the end of December last year, so this triplet, this at ESMO, if our abstract is accepted, this will be the first data for the triplet showing safety. And at this point, we have mature, enough response rate data that we’ll be able to share that. But remember, these patients treated with triplet therapy do extremely well with a long progression-free survival. And so, we will not have mature data for any time to event endpoint, such as PFS or even duration of response.
Okay, very helpful. Thank you.
And we will go next to Biren Amin from Jefferies.
Yes, hi guys. Thanks for taking my questions. Just on this FDA meeting, Mark, when would you provide, I guess, an update from that meeting? Would it be after you receive the FDA minutes?
I think that will be the most prudent course. I think if the dialogue in the meeting is unequivocal and unambiguous, then that would provide an opportunity for us to communicate. I think to the extent that there are more complex nuanced conversations that would probably benefit from minuting then we might wait to have the benefit of the written communication from the agency.
Got it. And then, I think through the course of this conference call, you’ve communicated that your external advisers view the data as consistent. But would they view the data as clinically relevant as it relates to PFS and OS in the FR high patients?
Yes. The reason I say that, Biren, is in platinum-resistant ovarian cancer, the median overall survival is somewhere between 11 and 14 months. And really no monotherapy has ever demonstrated an overall survival benefit in this patient population with such high unmet need. We do continue to follow our patients for overall survival. And while that is important and as I would argue that’s the gold standard, other characteristics are equally as important, including progression-free survival response rate and patient-reported outcomes. Ultimately, we want patients to feel better and live longer. And so far, all of the efficacy parameters that we’ve looked at suggest that in our minds mirvetuximab will be an important addition to the armamentarium for these patients who have limited options with poor outcomes currently.
Alright. And then, I guess, from our review, we haven’t seen the full data, and I guess we won’t until ESMO. So, I guess, with FDA meeting and where you provide the full data, would you characterize if there’s any baseline imbalances in the FR high patients across arms?
Given the analyses that we’ve looked at in the ITT population and the prespecified high FR alpha subset, we do not see any glaring imbalances that could confound interpretation of the data.
Great thank you.
Our next question comes from Jonathan Chang from SVB Leerink.
Hi guys. This is David on for Jonathan. Thanks for taking my questions. Just wanted to get kind of a general opinion on this without going too deep into the data, but now that you’ve had a chance to look at the FORWARD I data a little bit further, how, are you thinking about folate receptor alpha as the prognostic factor? And can you give any guidance on how your thinking has changed on that?
So, there are some retrospective data in the literature suggesting that folate receptor alpha is a poor prognostic factor, and we remain interested in assessing that. I would say that the data from our Phase 3 trial are quite important in that regard. As a reminder, we enroll patients with medium and high FR alpha expression. We did not enroll patients with lower or a negative FR alpha expression. And so, I think our data set will be important to help folks start to understand FR alpha as a prognostic factor, but I’d say there’s more work to be done there. The important point, though, is that FR alpha is a predictive factor for benefit from mirvetuximab.
Great. And just wanted to ask again, if you could give any potential path forward following discussions with regulators, if you could just tell us a little bit about how you’re thinking about the folate receptor alpha high group? And kind of what that looks like?
So, I think the question is, if the FDA is receptive to this data package, then our expectation would be to file a BLA before the end of this year. If they’re receptive given the unmet need here, I think we could reasonably expect under the circumstances to obtain priority review for that application, and so the approval would follow in a 6 to 8 months’ timeframe after the filing. So, does that answer your question?
Yes. That’s helpful. And then just one more for me, now, if you could just clarify for the combination studies, both the Avastin combo and the triplet, do those have the same mitigation strategies for adverse events as the monotherapy, for example, the eye drops?
Yes, yes, they do. And I should also mention, we do have an ongoing second mirvetuximab plus Avastin cohort that is currently enrolling as well. And I should also mention that after FORWARD I closed and we announced the data, enrollment in that combination has actually picked up a bit.
Great. Thanks so much and appreciate the follow-up.
Boris Peaker from Cowen has our next question.
Great. Thanks. So, just probably further on the FORWARD I data set. I mean, we’ve talked a lot about the folate receptor high patients. You haven’t disclosed obviously a lot of data on the folate receptor, the medium expressers, but my back calculation suggests that they had a positive hazard ratio. Can you comment on that, why was there a positive hazard ratio for that subgroup or what could have caused that relative to the control used by physicians?
So, as a reminder, when we designed the trial, we did so with a relative paucity of data, but all of the data that we had suggested two things: one, the higher the folate receptor alpha expression, the deeper and more durable the tumor shrinkage; and two, the mediums, they looked like they were benefiting at least as well as chemotherapy. And we felt that from the safety profile of mirvetuximab, there could be a real advantage in terms of no hair loss, less neuropathy and less myelosuppression. So, we felt – again, when we designed the studies that it was likely that the mediums would do at least as well as the chemotherapy. As you know from your calculations, Boris, the efficacy really seems to be in the high FR alpha subgroup. And so we have a path forward to select the patients who are most likely to benefit from mirvetuximab and exclude those who might not. And we do look forward to submitting – to presenting the full data set, so everyone can see the data for themselves at a major medical meeting.
Got it. Can you think of any kind of an example, I’m just curious if you’ve done an analysis where the FDA has accepted a subgroup of a study as a basis for approval when there was a clear strong efficacy signal from that subgroup?
So, what distinguishes our study is that this was a prespecified subgroup. This was not a post-hoc analysis. However, this study did not meet the primary endpoint based on how we designed it, and this is why we look forward to engaging in FDA with the path forward for approval.
Great. And just lastly on 632, I’m just curious if you could comment on how many relapsed/refractory AML patients and separately, how many BPDCN patients have you enrolled to-date?
I can’t comment on the exact numbers, but since ASH, we have continued to enroll both AML and BPDCN patients, and we look forward to sharing data at ASH at the end of this year if our abstract is accepted after we submitted.
Right. Thank you very much for taking my questions.
[Operator Instructions] Our next question comes from Jessica Fye from JPMorgan.
Great. Good morning, guys. Thanks for taking my questions. Just following up on the last question, I thought it was interesting. Is there a person you can think of where there was a pre-specified subgroup that represented the basis for approval? And then on 632, can you help us think more specifically about when you might be able to select the go-forward dose, trying to understand is that something that we could hear say prior to ASH to the extent that’s moving along nicely or if we should just expect to kind of share that update when we see the next data update?
Yes. So, regarding regulatory precedence, I do believe there was one for pemetrexed, where they were able to get approval in a pre-specified subset despite a negative outcome. I’m not able to share the details, but I would point you in that direction as a regulatory precedence. Regarding 632, could you repeat the question, sorry?
Yes. It was just the potential for us to hear about selection of the go-forward dose kind of as a data point for progress prior to actually seeing the next data update, which best guess would be like December?
I don’t think we can commit to a timeline, but we are planning to start combination work with 632 this year.
Okay, thank you.
Our next question comes from Debjit Chattopadhyay from H.C. Wainwright.
Hey, good morning. So, was the PRO collected in all patients prospectively? And the reason I ask is because Mark you mentioned, you need – at least historically, in the EMA combination of a PRO plus PFS, it would be acceptable?
Yes, Debjit. We had a prespecified key secondary endpoint that was based on PROs. We used the same tool and subscale that was used in the AURELIA study. There is a JCO article from 2014 by Stockler, where they present the PRO data from the AURELIA study showing that when you add bevacizumab to chemotherapy and compare it with chemotherapy, there is an improvement of greater than 15% in – sorry, greater than 15 points in the six-question subset of abdominal and GI symptoms. So, in other words, the six key questions that are really focused on symptoms from cancer, patients who got bevacizumab and chemo did better, they felt better than chemotherapy. So, we applied the same PRO analysis to our data set and we look forward to sharing those data at a future medical meeting.
So, Anna, just to clarify, the enrollment criteria, how closely from an exclusion perspective are patients at risk for abdominal bleeding events? Was that similar to the AURELIA from an exclusion perspective?
Our trial looked at monotherapy mirvetuximab versus monotherapy chemotherapy. So, the exclusion criteria for Avastin were not really relevant for our trial, Debjit. So, patients who are at risk for abdominal perforation or bleeding based on their tumor really should not get on Avastin-containing regimen. So, for our trial, we had no specifications around that. And in fact, we – Avastin is approved with chemotherapy in 1 to 2 priors, but as you point out, it’s not appropriate for everyone, so patients do need more options.
Great. And then from your discussions with your investigators, how are they defining a clinically relevant benefit? Is it greater than 2 months or 1.5 to 2 months, there’s plenty in this indication, especially if it – there are – there is a trend towards increased overall survival even though it’s – may not the stats say given that the study was not powered for it?
Yes. So, our view is that it’s the totality of the data exactly, where it’s PFS overall response rate, overall survival, who is really benefiting, how long are they benefiting, how do they feel and what price are they paying from a side effect perspective, right?
So, just one last follow-up. So, in case – just playing a devil’s advocate, in case there is a pushback on the BLA filing, would you consider proceeding with another single-agent study or would you pivot to a combination with Avastin or the triplet given that you’re seeing uniform benefits in 1 to 2 versus 3 as you mentioned in your prepared remarks and during the questions? Thank you so much.
Yes. I think it’s going to depend on what the regulators have to say about the existing data set. We were able in this study to identify a prespecified subset of patients with FR alpha high. And if the FDA don’t think those data – the totality of those data are compelling then I think that drives us down one path. If on the other hand, their view is – looks good, but want to see more patients, that gives us a different set of considerations. And so that’s – I think it will depend on what they have to say. What we can say at this point is, we are moving forward with combination studies. We’re encouraged by those data and we will continue that work.
Thank you so much and good luck.
Thank you.
[Operator Instructions] And it appears there are no further questions at this time. Speakers, I’ll turn the conference back to you.
Great. Thank you. We very much appreciate your time and look forward to keeping you up-to-date on our progress, including the outcome of our regulatory discussions this quarter and to seeing you all at ASCO. Thanks.
And that does conclude our conference today. Thank you for your participation. You may now disconnect.