Good morning, welcome to ImmunoGen's MIRASOL Top Line Data Conference Call. Today's conference is being recorded. At this time, I'd like to turn the call over to Anabel Chan, Head of 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 top-line results from our confirmatory MIRASOL trials ELAHERE in ovarian cancer. This press release, a recording of this call in an updated corporate deck, can be found under the Investors and Media section of our website at immunogen.com. With me today are Mark Enyedy, our President and CEO, and Anna Berkenblit, our Chief Medical Officer. Isabel Kalofonos, our Chief Commercial Officer, and Michael Vasconcelles, our EVP of Research, Development, and Medical Affairs, will join us for Q&A. During today's call, we will be making forward-looking statements based on our current expectations and beliefs. These statements include those related to the potential full approval of ELAHERE and the continued development of the broader ELAHERE program and are subject to risks and uncertainties, and our actual results may differ materially. Please consult the risks and uncertainties outlined in our press release issued this morning in the Risk Factor section of our most recent annual report on Form 10-K and in our quarterly reports on Form 10-Q and in our other SEC filings, which are available at sec.gov and immunogen.com. The forward-looking statements in this presentation speak only as of the original date of this call, and we undertake no obligation to update or revise any of these statements. With that, I'll turn the call over to Mark. Thanks, Annabelle. Good morning, everyone, thank you for joining us. My comments to start will be brief so that Anna can share with you more of the details on the MIRASOL data. Four years ago, we set out with a single objective in mind: deliver a randomized controlled trial that would show a significant improvement in overall survival with ELAHERE compared to chemotherapy. We have arrived. MIRASOL is a home run. The trial resoundingly met not only the primary endpoint progression-free survival but also ORR and, most importantly, overall survival. This is an unprecedented result in platinum-resistant ovarian cancer. Simply put, ELAHERE is the first medicine to demonstrate a survival benefit in this patient population. Keeping patients on therapy is essential in advanced disease. To that end, we are pleased that these remarkable efficacy data are balanced by a consistent safety profile aligned to our prior clinical experience with ELAHERE. With these results now in hand, we will move forward with an MAA submission in Europe and the efficacy supplement in the U.S. for the conversion to regular approval. We anticipate completing both during the second half of the year and look forward to working closely with both EMA and FDA throughout the process. With that, I'll turn the call over to Anna to review the top-line data. Thanks, Mark. We're absolutely elated with the positive top-line results from MIRASOL and are grateful to all the patients, investigators, and colleagues who contributed to this trial and the entire mirvetuximab program over the years. Recall that MIRASOL is a randomized Phase III trial of mirvetuximab versus investigator's choice of chemotherapy, weekly paclitaxel, pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer whose tumors express high levels of folate receptor alpha and who have received up to three prior regimens. The primary endpoint is progression-free survival by investigator assessment, and the key secondary endpoints include objective response rate, overall survival, and patient-reported outcomes. I would note that patient-reported outcomes are not included in today's top-line data release but will be shared later this year. MIRASOL enrolled 453 patients. The treatment arms were well-balanced for demographics and baseline characteristics. 14% of patients had 1 prior line of therapy, 39% had 2, and 47% received 3 prior lines of therapy. 62% of patients received prior bevacizumab, and 55% received a prior PARP inhibitor. Paclitaxel was the most commonly chosen chemotherapy on the control arm, followed by pegylated liposomal doxorubicin and then topotecan. With a median follow-up time of 13.1 months for survival, the top-line data are based on a cutoff date of March 6, 2023, at which point 14% of mirvetuximab patients remained on study drugs, compared with just 3% on the control arm. Let's start with safety. The safety profile continues to consist of predominantly low-grade ocular and gastrointestinal events. No new safety signals were identified in MIRASOL. Compared with IC chemo, mirvetuximab was associated with lower rates of Grade 3 or greater treatment-emergent adverse events, 42% versus 54%, serious adverse events, 24% versus 33%, and importantly, a lower rate of treatment-emergent adverse events leading to discontinuation of study drug, 9% for mirvetuximab versus 16% for chemotherapy. Moving on to efficacy. The primary endpoint of the study, progression-free survival by investigator, was met with a highly statistically significant improvement in PFS with a hazard ratio of 0.65 and a P value of less than 0.0001. This corresponds to a 35% reduction in the risk of progression or death for the ELAHERE-treated population and was associated with a median PFS of 5.62 months in the MIRV arm versus 3.9 months, 3.98 months in the chemotherapy control arm. Looking at secondary endpoints, the key secondary endpoint, overall response rate was also highly statistically significant. On the MIRV arm, ORR was 42.3% compared with 15.9% on the chemotherapy control arm. 12 patients on the MIRV arm had a complete response compared to none on the chemotherapy arm, as reported by investigators. DFS and ORR results by blinded independent central review were concordant with investigators' assessments. Let's now turn to overall survival, clearly the most meaningful clinical endpoint. With 204 events reported, overall survival results were highly statistically significant at this protocol-specified interim analysis with a hazard ratio of 0.67 and a P value of 0.0046. This hazard ratio corresponds to a 33% reduction in the risk of death in the ELAHERE treated population compared with the chemotherapy-treated population. On the MIRV arm, the median overall survival was 16.46 months compared with 12.75 months on the chemotherapy control arm. Let me pause here to reflect on how important these data are. No drug has ever demonstrated an overall survival benefit in platinum-resistant ovarian cancer. Many have tried. The field is littered with Phase III trials that have failed. Despite remarkable advances elsewhere in oncology, available therapies for platinum-resistant ovarian cancer have remained single-agent cytotoxics that have been around for decades. What's more, even PARP inhibitors, which have demonstrated tremendous benefit in ovarian cancer, have experienced recent setbacks, including withdrawals of indications due to an overall survival detriment in recurrent disease. This highlights just how challenging drug development in this space is. It is against this dismal backdrop of high unmet need that the results from MIRASOL will be viewed. The overall survival benefit we have demonstrated comparing mirvetuximab head to head against available therapies is unprecedented. Patients are living longer because of mirvetuximab. These results, the highly statistically significant and clinically meaningful improvements in all efficacy endpoints, along with the consistent differentiated safety profile of mirvetuximab, will enable us to engage with regulatory authorities to advance the marketing authorization for ELAHERE in Europe and elsewhere, and support conversion from accelerated to full approval of ELAHERE in the U.S. for patients with platinum-resistant ovarian cancer. We look forward to analyzing the data from MIRASOL further and presenting full data from the trial at a medical meeting later this year. Before I turn the call over to Mark, I really want to thank everyone who has hung in there with us, including all the investigators on the MIRV program, especially Katie Moore, the MIRASOL PI. She treated the first patient with mirvetuximab ever and has given it to well over 100 patients on clinical trials. A special thank you to all my ImmunoGen colleagues who have also stuck it out. Most of all, I want to thank Mark Enyedy for his exemplary leadership. Mark? Thank you, Anna. As we mentioned on our Q1 earnings call, we continue to make significant progress with the launch, highlighted by the breadth and depth of adoption, strong demand for FRα testing, favorable market access coverage, and just recently, the assignment of a permanent J-code. We are very pleased with this enthusiastic reception to ELAHERE and believe the MIRASOL data will further accelerate the momentum of the launch. Just to close our prepared remarks, I would also like to express our deep appreciation to the patients, families, caregivers, and investigators for their commitment to this trial. I would also like to commend the ImmunoGen employees who work relentlessly with high degrees of determination and professionalism to deliver the MIRASOL trial. Thank you, Anna, for your leadership. Through those efforts, we have further solidified ELAHERE as a first-in-class biomarker-driven ADC and marked an unprecedented moment for our organization as we seek to improve outcomes for ovarian cancer patients and offer them more good days. Before we open the line for questions, I'd just like to remind everyone that while we've disclosed the key top-line results from MIRASOL, including the primary endpoint, we cannot discuss the full results of the study today in order to preserve the opportunity to present the data at an upcoming medical meeting, as Anna Berkenblit mentioned. You may have some questions that we're unable to answer, but we'll do our best to provide as much clarity as possible. With that, we'll open the call for questions. Operator? Thank you. At this time, we'll be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question comes from the line of John Newman with Canaccord Genuity. Please proceed with your question. Good morning, everybody, and I know that we hear this a lot on conference calls, but I wanna extend my congratulations to the team. Really excellent execution, especially given the COVID pandemic. Great job on the results. I've just got one question, as I'm sure we've got a lot of questions in the queue. On the progression-free survival data, I saw a very small P value. To me, that would suggest very clean separation of the Kaplan-Meier curve. I wondered if you could give us any color there, if that's what qualitatively you're seeing. Thanks. Yes, John. The mirvetuximab arm separates quickly from this investigator's choice chemotherapy arm, and the separation in the curves continues and widens. This trial has behaved exactly as we anticipated. We have always seen throughout the mirvetuximab development program what we call a long tail on the curve. There are many more patients without progression, and also this holds for overall survival as time goes on. I can't tell you how excited we are to share the curves with you in an upcoming major medical meeting. Okay. Excellent. Thank you. Thank you. Our next question comes from line of Michael Schmidt with Guggenheim Securities. Please proceed with your question. Hey, guys, Mark and team. Truly want to congratulate as well to this amazing data and outcome of the MIRASOL study. Now, you know, I think the data is even better than, you know, many of us had expected in terms of the response rate, the OS benefit, and also the PFS differential. Does that result in any way change how you think about potential label extension opportunities at this point? The plans that we have in place, you know, you will recall. I mean, first, the way we think about MIRASOL is, it facilitates the expansion into Europe and in particular, you know, going to EMA with a survival benefit, in this type of population, an unprecedented outcome we think will, you know, support the review there and more importantly, facilitate the conversations with the payers, to have, you know, a, an effective price in those, in those markets. You know, the first point is this enables geographic expansion, and international growth, for the brand in the first instance. Then as it relates to, the expansion studies, as you know, we've got, you know, 2 ongoing. One is GLORIOSA, and Anna has a high degree of confidence in the outcome, as do I, looking at a maintenance label. Then in parallel, we have Study 420 combining with carbo. You know, the goal there is to look at mirve as a potential replacement for paclitaxel in the carbo-based platinum-sensitive doublets and ultimately, triplets. You know, these data give us, you know, greater confidence in both of those studies. Last is really the PICCOLO study, which is single agent, ELAHERE, in later line platinum-sensitive patients. We expect to publish the ORR data from that study later this year. You know, when you look at these results, for example, you know, a 42% response rate, in the platinum-resistant setting, you know, we're very encouraged by these results, and think it speaks well for the broader program here, which is to move into broader patient populations, particularly platinum-sensitive disease, and have, you know, ELAHERE serve as the combination agent of choice across the entire ovarian cancer therapy continuum. Makes sense. Is there any particular reason why the response rate was even higher compared to what you saw in SORAYA? you know, it sounds like there's some clear paths that we could take to Piccolo and perhaps other ongoing studies. Yeah, Michael, this trial has behaved exactly as we anticipated. Remember that in SORAYA, all patients had prior bevacizumab, and we described them as a worse population than those patients in MIRASOL. You know, in part because bevacizumab is often reserved in the frontline setting for poor-risk patients with stage 4 disease, ascites, suboptimal debulking. Indeed, in the MIRASOL study, where even though 62% of patients had prior bev, you know, 38% didn't. Overall, it's a better population, and that's why the response rate is not 32%, as we saw in SORAYA, but 42%. Great. Thanks so much, congrats again from me. Thank you. Thank you. Our next question comes from the line of Etzer Darout with BMO Capital Markets. Please proceed with your question. Great. Thank you for taking the question. It's gonna be a redundant theme on the, on this call, but congrats here on the MIRASOL data set. Just maybe to just follow up, just, you know, your assumptions and the team's assumptions on PARP and the role that it could potentially play in these patients seem to have just a kind of play through here, given sort of the benefits that we've kind of seen here across the board. I just wondered if you could comment at all on any specifics around sort of the impact here on the results, on response, on survival, just relative to your expectations. Also just again, given sort of the data we see today as we think about sort of, earlier settings, you know, even sort of the adjuvant, you know, how this sort of maybe changes or increases sort of confidence around outcomes for in those populations as well. Thank you. Thanks, Etzer. PARP inhibitors have evolved the treatment landscape in the frontline setting, no doubt. As you know, more and more data are coming out suggesting that patients who've had a PARP inhibitor don't do so well with subsequent therapies, particularly agents that are DNA damaging, which have the potential for cross resistance with PARP inhibitors. Further platinum, Doxil, topotecan, those things. All along, we've been saying that we don't anticipate cross resistance for mirvetuximab with the, you know, the mechanism with PARP inhibitors. All I can say is the trial is behaving exactly as we anticipated, and I can't wait for us to share those details. Actually the control arm on the MIRASOL study, looking at the subset of patients who have had a prior PARP inhibitor and who haven't, that's gonna be really important data for the field of ovarian cancer in general. Stay tuned for more data. Second question about earlier lines of therapy and adjuvant therapy. You know, we are very excited about what I would call our three-pronged approach to gather more data for mirvetuximab in combination with carboplatin. We have our sponsored study, Study 420, which is enrolling, and that's a single-arm study in recurrent platinum-sensitive disease. We have also supported two investigator-sponsored trials for mirvetuximab plus carboplatin. One is in Germany, led by Philipp Harter in the AGO. That's a randomized Phase II trial of mirve carbo versus standard of care. A neoadjuvant study here in the U.S. led by Rebecca Arent. I think those three studies will give us the data that we need to understand how best to move Mirve carbo up. Great. Thank you. Congrats again. Thank you. Our next question comes from the line of Peter Lawson with Barclays. Please proceed with your question. Thank you so much. Thanks for taking the question, and congrats on the data, of course. Just wonder if you can kind of talk through the timing and strategy for the EU and ex-US, and whether you plan to commercialize on your own or if that goes through partnerships, and then kind of any color you can provide around the rate and severity of ocular toxicities and how that was dealt with in the trial, if that was better at than SORAYA. Thanks, Peter. I'll tackle the question on global markets, and then, I'm gonna ask you though to repeat the second part of the question 'cause it got a little bit muddled on the speaker phone here. You know, first, as it relates to global markets, we intend to go direct where we think we can support those markets and capture the full value with, you know, modest incremental investment. Our first go is at Europe. We expect to file the MAA before the end of this year. We'd expect, you know, a regular review at this point, and, you know, to be able to get an approval sometime late next year for the program. Europe is a highly concentrated market. We've done some market research there. When we look at the five largest markets, there are about 65 centers that cover over 70% of the market. Given that degree of concentration, as I mentioned, it's a relatively modest incremental commercial investment to, you know, support that market with a robust commercial effort. You know, we've learned a lot. In the US market, obviously, there are important differences as it relates to Europe and in particular, you know, centralized payers. The research that we've done so far, and particularly with the benefit of survival data, we would expect a favorable pricing and reimbursement environment in the national markets there. Outside of that, we've put in place a strategic partnership with Huadong Medicine for China. They're making great progress and expect to file their own BLA in the second half of this year. Are also exploring strategic partnerships for some larger markets like Japan, again, where it would be more challenging for us to go direct. Our expectation is to be able to pull together a network of distributors in adjacent markets, so for example, in Eastern Europe and around, you know, the Middle East, to put together distribution agreements that we could recall over time as we gain, you know, a solid footing and could support those markets from what we establish in Europe. That's the thumbnail sketch. We've opened an office in Zug. We have a general manager for international, Massimo Radaelli, who brings 30 years of experience to those markets, are very much looking forward to engaging with the EMA and the and our rapporteurs in the near term. With that, let me ask you if you could maybe repeat the second question. I think it had to do with adverse events, but if you wouldn't mind. Yep. Yep, certainly. It's just around any details you can give around the ocular AE side effect profile, if it was managed better on the trial or if the real world setting, if that's, if that's getting even better with managing the ocular toxicity? Peter, there were no surprises in MIRASOL. You may recall that when SORAYA led to the accelerated approval of ELAHERE in the U.S., we actually had a much more robust safety database than most accelerated approvals have. We had 464 ovarian cancer patients, and now the MIRASOL data adds more than 200 more patients there. The safety profile, you know, what we're seeing in MIRASOL is very similar in terms of rates and severities for adverse events. I think, you know, most importantly, the rates of discontinuation for treatment emergent adverse events in MIRASOL are even a little less than they were in SORAYA. I think that speaks to investigators understanding how to manage patients on mirvetuximab to keep them on drug as long as possible, as long as the drug is helping them. Great. Thank you so much. Thank you. Our next question comes from the line of Andy Hsieh with William Blair. Please proceed with your question. Great. Thanks for taking the question. Congratulations to everybody at Unity. What a historical day. Thanks. I have 3 questions. One has to do with the control chemotherapy arm. Paclitaxel was the most commonly used, which also happens to be the strongest chemo. That's kind of a dynamic that's stacked against you in a sense, especially compared to FORWARD I. Can you comment on that dynamic? What really changed in terms of physicians' choice from the FORWARD I era? Number 2, the complete response rate data was very provocative. I'm curious if you could share your perspective on the significance of this endpoint. Number 3, back to Michael's question before. Is there a sense from you that physicians are better at using ELAHERE versus several years ago that could explain the improvement in a lot of these efficacy endpoints? Also, can you expect this improved outcome in the real world setting as you continue to launch ELAHERE? Thanks. Great, Andy. Regarding your three questions, I just want to let folks know that Katie Moore has dialed in in the middle of the night from Hawaii to join us at least for this part of the Q&A. I would love to give my initial remarks regarding your questions and then turn it over to Dr. Moore, who is the PI of the study and is the Associate Director of Clinical Research and the Director of the Oklahoma TSET/Sarah Cannon Phase I Program, Professor of the Section of Gynecologic Oncology at the University of Oklahoma. First, I will give a couple highlights and then turn it over to Katie, because I think of anyone in the world, she's the best positioned to tell you what it really is like. From my perspective, as a clinical trialist, yes, paclitaxel is the most active of the three drugs that are available therapies that were used in the control arm. Yes, more patients, a higher percentage of patients were randomized to the paclitaxel stratum in our study than in FORWARD I. My hypothesis is that because more patients now are getting Doxil in the recurrent platinum-sensitive setting with carboplatin, with or without bevacizumab. There's only so much Doxil they can get, it may be less of an option in the platinum-resistant setting. I think our study bears that out. All I can say about efficacy is tremendous consistency across every subset that we've looked at. I look forward to sharing those data, and that's with regard to ORR, PFS, and OS. Your second question regarding a CR rate. You know, in SORAYA, we saw a handful of complete responses. Here again in MIRASOL, we are also seeing complete responses. You know, investigators, physicians don't expect that. They don't counsel their platinum-resistant ovarian cancer patients that they have a hope for a complete response. This really is remarkable. To your last question, I do believe, at least as we've understood the safety profile of mirvetuximab, we've been able, through our clinical trial guidance in the protocol and, you know, our education of sites, we've been able to help them understand how to manage patients on mirvetuximab. I do believe that physicians who have participated in our trials have learned that, and we're sharing those learnings, with physicians in the real world setting. Dr. Moore, if you're there, can you pipe up and would you like to add a few words? Good morning, everyone. I am definitely here. Nothing gets me up in 2 A.M., at 2 A.M. in Hawaii, but a positive trial. Here I am. I really agree with the answers that were given by Dr. Berkenblit. The first part of your question is a very accurate one. Weekly Paclitaxel is definitely our most active regimen in the platinum-resistant ovarian cancer setting. There's no question. I think I have to be careful what I know and what I can say, but just to echo what Dr. Berkenblit said, as you heard, there's more of them on this study who received weekly Pac, and yet we are still, you know, profoundly positive. More to come as you see the breakdown, but this really is an agent that works, and the presentation of the data is going to show that definitively. I'm excited to sort of answer that question with real-world data. With real trial data, pardon me. In terms of the ability to use in the community, going way back to FORWARD I, you know, this was the thing we were worried about when we launched FORWARD I globally was: Would the sites be able to mitigate the ocular, the visual disorder risk? The answer was just this resounding yes. Patients were able to do the eye drops globally. We were able to get the optometric, ophthalmologic or optometry assessment. I presented this at ASCO last year, so I can talk about that set of data, was a pooled analysis of all the ocular events, and only 1%, actually a little less than, of patients discontinued because of ocular events. That has been consistent in this study. I do think that our sites are used to not only dealing with ocular disorders with this agent, but there are increasingly other agents and even other mechanisms of action that require ocular mitigation strategies. I think oncologists in general, and gyn oncologists included, are just used to this now. We work with ophthalmologists. We have those patterns in place. This is just gonna flow, I think, right into standard use and you can see it in market data with the uptake of mirvetuximab following SORAYA as well. It's being used and successfully, and I think it's just gonna be an easy transition to a widely available medication globally. Thank you, Dr. Moore. Thank you. Our next question comes from line of Boris Peaker with TD Cowen. Please proceed with your question. Great. Thanks for taking my questions, and I'd like to add my big congratulations as well. Clearly the theme on this call today. Two questions. First, just wanna get a sense of how long are people staying on ELAHERE, what can we derive from this study? The second one is what are the next steps in kind of getting this information out there, maybe incorporation in NCCN guidelines, medical meeting presentation? Just wanna get a sense of when will physicians be able to really familiarize themselves with this data. Yeah. Thanks, Boris. You know, we have top line data here. We look forward to sharing additional information regarding duration of therapy. What I would say is, you know, at this point you have the point estimate for the median PFS. We know that there is a nice tail on the curve. I, you know, the median really doesn't represent the true value and the true duration of therapy. That's the first point I'd make. The second point that I'd make, you mentioned NCCN guidelines. You know, we are already listed in the NCCN guidelines as a 2A. There is nothing in NCCN guidelines for platinum-resistant disease that is a category one, because nothing in platinum-resistant ovarian cancer has ever shown an overall survival advantage. I think we have the potential to change that for NCCN. Is there a timeline that where this change could happen? I don't know how frequently the NCCN meets and this particular group revises guidelines. I don't wanna speak for NCCN. They certainly do update guidelines on a yearly basis and more often when there is practice-changing information. Great. Congratulations again, and thanks for taking my questions. Thanks, Boris. Thank you. Our next question comes from line of Kelly with Jefferies. Please proceed with your question. Okay, thank you. First please allow me adding congrats to the tremendous success achieved by the ImmunoGen team. Firstly, I'm curious, how big is the market size of ELAHERE in Greater China? Secondly, regarding that very remarkable 5% CR rate consistently observed across trials, what is there any common like baseline characteristics can be found among the patients who achieve the CR? Thank you. Thanks, Kelly. Our partners at Huadong Medicine tell us as it relates to a commercial market for ELAHERE and, you know, meaning, you know, sufficient reimbursement and access for patients that the market in China is roughly equivalent in size to the market here in the United States. With that, I'll turn it over to Anna. Yeah. Kelly, thank you for commenting on the CR rate. You're right, it seems like we have a consistent 5% CR rate. You know, that translates into a handful of patients in SORAYA and a couple of handfuls of patients in MIRASOL. As we have more patients who receive ELAHERE, we'll have more of them. There's certainly some hypotheses around that. One is that it could be the subset of patients with the highest FRα expression, like 100%, 3+. Or it could be just a factor of disease burden, right? How RECIST criteria are used to document complete response. I look forward to a future publication teasing that apart. Okay, great. Thanks. Thank you. Our next question comes from the line of Swayampakula Ramakanth with H.C. Wainwright. Please proceed with your question. Thank you. This is R.K. from H.C. Wainwright. Congratulations, Anna and Mark. I know this is a great day for you folks. Couple of quick questions. I know there are studies being conducted as combination therapies with bevacizumab and also with carboplatin. Is there any other combinations that you're thinking of even, you know, if even if it's other chemotherapy that you could test? The other question is, do you also foresee yourselves trying to use trying to start a study as a first-line therapy as soon as the patient gets diagnosed with FRα positive, positivity when on newly diagnosed patients? Thanks, RK. Regarding other combinations, we have in our strategy, we have prioritized combining with PARP inhibitors. Toward that end, we are supporting an IST led by Bradley Corr, combining with a PARP inhibitor. Early days there. Also we have a collaboration with Shattuck, where mirvetuximab is being combined with their CD47 Don't Eat Me agent, which is quite interesting. Those are the two combinations we have at this point. I think, you know, to the earlier conversation we had about the data that we're generating with mirvetuximab in combination with carboplatin, it's really those three studies that are ongoing that will help inform really how and when to move mirve up into the frontline setting. Thank you for that. One quick question. I, trying to change the topic here a little bit. On 151, does the data that we have seen with mirvetuximab, being as good as it has been, does it put a lot of pressure on the 151 molecule? RK, mirvetuximab is fantastic for patients with high FRα expression. That's about 35%-40% of patients with ovarian cancer. I also personally know that it is pretty darn good for patients with medium levels of FRα expression, from a clinical trial perspective, as you recall, in FORWARD I, we had some challenges there. I do think the patient population that can benefit from mirvetuximab is broader than what I would call our FRα targeted biomarker, targeted population based on the CDx. That being said, you know, looking at our preclinical data, benchmarking IMGN151 against mirvetuximab, just imagine if mirvetuximab is this good, imagine how amazing IMGN151 could be for patients with, you know, much lower levels of FRα expression. Perfect. Yep. Thank you very much. Thanks for taking all my questions. Thank you. Our next question comes from the line of Asthika Goonewardene with Truist Securities. Please proceed with your question. Hi, guys. Good morning. I'll also offer my congratulations on the data. I don't think you can hear this enough today, well done on this. Thank you. I have a question for Dr. Moore and then a question for Mark. Dr. Moore, can you tell me, are you as impressed with the PFS benefit in patients who got weekly paclitaxel as you are impressed with patients who got other chemo on the MIRASOL arm, on the MIRASOL study? To Mark, you know, last week in your one two sales numbers that suggested ELAHERE is already on a very robust trajectory this year. Given this MIRASOL update and prior to a formal label update, do you expect that trajectory to change? I will start with the. Yeah, I'll start with the easy question. Am I as impressed? Yes, I really am, because I will tell you, the question is really on point, and everyone wants to know this answer, and I don't think I can give the specific granular data yet, but I've seen it, and I'm as impressed. I will be using this. I think I said that in the press comment that really the benefit of mirvetuximab demonstrated in MIRASOL justifies moving it up in the platinum resistance phase as early as possible. I will say that, you can kind of see what the data looks like when we can show you the more granular data. I'm very impressed, and I will be using it. I mean, I already use it, but I think everyone else will start using it at that point. Yeah. As it relates to the launch, I think the first thing to keep in mind is that you may remember that the FDA looked at the MIRASOL data while we were undergoing review for SORAYA. The label that we received from FDA actually includes the MIRASOL population. That is, there's no restriction on the use of prior Avastin in terms of the of the label. What these data do is they confirm the underlying assumptions as it related to the SORAYA outcome. You're working in that context, an accelerated approval with surrogate endpoints. Now we have the definitive statement with respect to the endpoints that support full approval, including PFS and more importantly, overall survival. certainly to the extent that there are folks who might have been skeptical, you know, looking at comparative data, against the things that they have in their toolbox other than, ELAHERE certainly provides the, you know, the impetus, to consider, to consider this drug. I would say the other observation here is, you know, the response rate that we report in the label currently is, you know, 31%, which reflects this, 100% of the patients, previously treated with Avastin. When we moved into a population that included, Bev naive patients, we expected, and in fact it materialized, that the response rate went up, and in fact it went up a full 10 percentage points, in the population. You have greater overall response rates, in the population, you know, confirmation that the complete response rates, are you know, consistently, observed and of course now a survival advantage. Great. Thanks. Thank you. Our next question comes from line of Joe Catanzaro with Piper Sandler. Please proceed with your question. Hey, guys. Thanks for taking my questions. Obviously congrats on the fantastic outcome here. Maybe first question, I suspect that there shouldn't be any differences. Wondering if you could speak to therapy's post progression and balance between the two arms, both in terms of percent of patients who received an additional therapy post progression and the types of therapies received post progression. Maybe one for Dr. Moore. You just mentioned moving it up earlier in the platinum-resistant setting, that these data support doing that. Wondering if you could speak how you expect that to maybe change duration of treatment when you know, use this as a second-line option relative to a fourth line option. Thanks. Joe, I just wanna let you know Dr. Moore actually had to step off to chair a session at a conference that she's leading. I think I'll just respond to her regarding the duration of therapy question. You know, in general, the earlier in therapy, the longer the duration of therapy. Yeah, it would not surprise me if, you know, we do see a shift over time as ELAHERE is incorporated into earlier platinum-resistant settings, that the duration of therapy is going to be longer. Regarding your question about post-progression treatments, remember we just got top-line data a few days ago. What I can tell you is that we look forward to sharing PFS2 data, which basically is the, from the time of randomization from our study to the time of progression of the second therapy. After you come off our study, you get a second drug, and then at that progression time. That's called PFS2. That's very important to the European regulators. We've looked at that, it is quite strong. I would say, you know, we already saw that in the FORWARD I study, and in the FORWARD I study, we dived deep into post-progression therapies, and it was well-balanced there. I anticipate when we look at the data in MIRASOL, we will see that post-progression therapies are well-balanced. Remember, we're not allowing crossover. Stay tuned. There's gonna be a lot of great data coming out of this study. Okay, great. Thanks so much, and, congrats again. Thank you. Our next question comes from line of Jonathan Chang with SVB Securities. Please proceed with your question. Hi, guys. Congrats on the results, and thanks for taking my questions. First question. Can you provide any more granularity on when and where we might see the full results presented? I cannot. Got it. Second question. How are you thinking about your cash position and strategies for extending the runway? Thank you. Yeah, we got it on the Q1 call that we have cash into 2025 with the benefit of both the ELAHERE forecast, and the credit facility with Pharmakon, just based on the initial draw. We obviously are in the wake of these data, considering additional financing options that would extend our runway. Got it. Thanks for taking my questions. Thank you. Ladies and gentlemen, we've reached the end of our question-and-answer session. I'd like to turn the floor back over to the team for concluding comments. Great. Thanks again for joining us today. This is obviously a very exciting time for ImmunoGen, and we think we are exceptionally well-positioned to continue to deliver value, most importantly for patients, but also for our employees and our shareholders. And look forward to continuing to execute on the ELAHERE launch, and advance the rest of the portfolio, and very much look forward to being able to present these data at a major medical meeting at some point in the future. Thanks again. Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.
Loading workspace