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ImmunoGen, inc (IMGN) Q3 2021 Earnings Call Transcript

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IMGN earnings call for the period ending September 30, 2021.

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ImmunoGen, inc (IMGN -1.67%)
Q3 2021 Earnings Call
Oct 29, 2021, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, and welcome to ImmunoGen's Third Quarter 2021 Financial and Operating Results Conference Call. Today's conference is being recorded.

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

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Courtney O'Konek -- Senior Director, Corporate Communications and Investor Relations

Good morning and thank you for joining today's call. Today, we issued a press release that includes a summary of our recent progress and third quarter 2021 financial results.

This press release and a recording of this call can be found under the Investors & Media section of our website at immunogen.com. With me today are Mark Enyedy, our President and CEO; Anna Berkenblit, our Chief Medical Officer; and Susan Altschuller, our CFO. During today's call, we will review key recent accomplishments for the business, our financial results and anticipated upcoming events.

During the discussion, we will use forward-looking statements with respect to our business strategy, the development and benefits of our product candidates, the presentation of clinical data for our product candidates, the anticipated timing of regulatory submissions to the FDA and EMA for certain product candidates, our 2021 financial outlook and our projected cash runway. This information is subject to risks and uncertainties. Our actual results may differ materially from such statements and include those described in the Risk Factors section of our most recent annual report on Form 10-K and our other SEC filings.

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

Mark Enyedy -- President and Chief Executive Officer

Thanks, Courtney. Good morning, everyone. And thank you for joining us today. In the third quarter, we advanced our pipeline and continued our prelaunch activities as we look to transform ImmunoGen into a fully integrated oncology company in the coming year.

Starting with our lead program mirvetuximab Soravtansine in platinum-resistant ovarian cancer, I am pleased to say that we are on track to report top-line data from our pivotal SORAYA study this quarter. For this release, we expect to include data on the primary endpoint of overall response rate as assessed by investigator, the sensitivity analysis of overall response rate as assessed by blinded independent central review, the key secondary endpoint or duration of response and the safety and tolerability profile of mirvetuximab.

We believe these data will provide a comprehensive picture of the results of the trial. We are planning for success with SORAYA and to that end our preparations for the BLA are well underway with the goal of submitting the application before the end of Q1, along with activities in support of potential launch of mirvetuximab in the second half of next year.

In addition to SORAYA, we are pursuing a broad program to establishment mirvetuximab as the new standard of care for patients with folate receptor alpha positive ovarian cancer. Our confirmatory MIRASOL trial continues to enroll and we expect top-line data in the third quarter of next year. If positive, these data could enable full approval of mirvetuximab in the US and importantly support an application for marketing authorization in the EU.

This past quarter, we also initiated PICCOLO, a single arm study of mirvetuximab monotherapy, designed to address the increasing unmet need for an effective, non-platinum option for FR-alpha high recurrent platinum sensitive ovarian cancer. Beyond mirvetuximab monotherapy, we have generated encouraging data with mirvetuximab in combination with bevacizumab and carboplatin. We believe mirvetuximab has the potential to become the combination agent of choice for ovarian cancer and we look forward to sharing our label enabling combination strategy next quarter.

As we continue to expand our team, we are very pleased to welcome Dr. Helen Thackray to our Board of Directors. Her deep development and regulatory expertise will be invaluable both in the near-term as we look to bring mirvetuximab to market and longer-term for our whole portfolio.

With that, I'll turn the call over to Anna to provide an update on the rest of our development pipeline. Anna?

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

Thanks Mark. I'll start with IMGN632, our CD173 targeting ADC in clinical development for hematological malignancies. As a reminder, IMGN632 is being evaluated as a monotherapy for patients with top line and relapsed/refractory and minimal now as combination with a fighting for patients with frontline and relapsed/refractory BPDCN and in minimal residual disease positive AML as well as in combination with azacitidine and venetoclax for patients with relapsed/refractory AML. IMGN632 uses our novel indolino-benzodiazepine dimer or IGN payload which is designed to alkylate DNA without crosslinking. Our IGNs are highly potent against leukemic blasts, while demonstrating less toxicity to normal marrow progenitors.

We are excited to share initial combination data from the AML cohort at ASH in December. Previously we reported data that demonstrated the monotherapy activity and favorable tolerability of IMGN632 in heavily pretreated AML patients, including a 40% overall response rate in relapsed and refractory de novo AML patients treated at the recommended Phase 2 dose. The combination data for IMGN632 with azacitidine and venetoclax we plan to share at ASH includes safety and anti-leukemia activity from dose escalations to guide further development of the triplet.

In a separate presentation, we plan to present [Indecipherable] frontline BPDCN patients who received IMGN632 prior to us commencing the currently enrolling pivotal cohort. Abstracts will be released next Thursday, November 4. IMGC936, our ADAM-9 targeting ADC, is advancing through Phase 1 dose escalation in multiple solid tumor types and IMGN151, our next-generation anti-folate receptor alkylate ADC, is on track for IND submission by year end.

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

Susan Altschuller -- Senior Vice President and Chief Financial Officer

Thanks, Anna. Starting with our results for the third quarter of 2021. We generated $9.2 million in revenue, which consisted primarily of non-cash royalty revenues and a $2.5 million anticipated partner development milestone fee. Recall, there was a reduction in non-cash royalty revenue starting in the third quarter and continuing forward due to the completion of the first tranche of payment under the 2015 transaction covering the sale of Kadcyla royalties.

Operating expenses were $43.4 million, comprised of $33.1 million of R&D expenses compared with $24.7 million in the third quarter of 2020 and $10.3 million of G&A expenses compared to $10.2 million in the third quarter of 2020. We ended the third quarter with $245.8 million in cash and cash equivalents on the balance sheet.

Moving to our updated financial guidance for 2021. Revenue guidance is unchanged at $65 million to $75 million. Operating expenses are now expected to be slightly lower at $190 million to $200 million and cash and cash equivalents have increased. We expect to have between $190 million to $200 million at year end. With the addition of approximately $43 million through our ATM facility and the sale of our pre-funded warrant to an investor during the quarter, we believe our current cash runway will be sufficient to fund operations into the fourth quarter of 2022.

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

Questions and Answers:

Operator

[Operator Instructions] Our first question comes from John Newman with Canaccord. Your line is open.

John Newman -- Canaccord Genuity -- Analyst

Hey, guys. Good morning and thanks for taking my question. Congrats on all the progress. Just one question on SORAYA, which is, after the data readout, is there any need for you to meet with the agency prior to the BLA submission in the first quarter? Thanks.

Mark Enyedy -- President and Chief Executive Officer

Need is an interesting choice of words. What I would say is that any sponsor is very well advised to meet with the agency ahead of the filing. It's called the pre-BLA meeting. Virtually all sponsors do that. So, yes, we will be talking to the agency between the top line and the filing.

John Newman -- Canaccord Genuity -- Analyst

Okay, great. Thank you.

Mark Enyedy -- President and Chief Executive Officer

Sure.

Operator

Our next question comes from Michael Schmidt with Guggenheim. Your line is open.

Mark Enyedy -- President and Chief Executive Officer

Michael?

Michael Schmidt -- Guggenheim -- Analyst

Yeah. Hey, guys. Sorry about that. Just a few quick ones from me. The primary endpoint of the study is obviously overall response rate per investigator assessment. Can you just talk about how important the independently assessed response rate is in the approval process? And so that's question number one.

And then the second question was just on the regulatory hurdle for duration of response. I think you've spoken about six months before. Some of your peers in ovarian cancer have spoken about a potential four months DOR hurdle, just wondering what your updated thoughts are on that?

Susan Altschuller -- Senior Vice President and Chief Financial Officer

Sure, Michael. So, as you know, our primary endpoint is overall response rate by investigator. And in the protocol, we have overall response rate by blinded independent central review as a sensitivity analysis. Consistent with prior approval in ovarian cancer, FDA will have both datasets available to them to inform the overall benefit risk.

Regarding duration of response for this population, there's not a lot of great data out there, but the study that has associated the 12% response rate is AURELIA and in AURELIA the control arm a single agent chemotherapy that had a 12% response rate, that was associated with immediate duration of response of 5.4 months. That being said, I can certainly understand other folks describing a meaningful duration of response of four months, because as you may recall, in AURELIA these are patients with platinum resistant disease with just one to two prior lines of therapy. It's essentially the bev naive population and we're going after frankly a higher unmet need group with -- including patients with three prior lines of therapy and they have all received bevacizumab.

That being said, you may recall that in our foundational 70 patients worth of data, we had a median duration of response of 7.8 months. And we believe that based on the 5.4 months from the AURELIA study, anything around six months or greater would certainly be clinically meaningful.

Michael Schmidt -- Guggenheim -- Analyst

Great. Thank you.

Operator

Our next question comes from Andy Hsieh with William Blair. Your line is open.

Andy Hsieh -- William Blair -- Analyst

Great. Good morning. Thanks for taking my question and congratulations on all the progress. Mark, I think you've mentioned something after the comments about Avastin and carboplatin combination that labelling and enabling combination strategies will be closed next quarter. Can you give us a little more color on that comment?

Mark Enyedy -- President and Chief Executive Officer

Sure. So, as you know, we have pursued a number of early stage studies looking at various mirvetuximab combinations and have been very pleased with both the activity and the tolerability of those combinations. So what we've typically seen is response rates and measures of progression free survival and duration of response that exceed the relevant benchmarks for the combination partner. So, for example, if you look at our early data with carbo and mirv, what we saw was response rates 70% to 80% of FR-alpha high patients and progressively survival of about 15 months and that contrasted nicely with other carbo doublets that have been reported where you see response rates in the mid-50s and progression free survival in the range of 8.5 and 10.5 months.

So, with the benefit of those data, along with what we've seen with mirv-bev, we are working through, as we speak, a comprehensive strategy that will include studies that will support formal label expansion with respect to these combinations. Some of that requires conversations with the agencies, with our investigators and so on. We are taking the fourth quarter to work through those points with them and look forward to talking to you in the first quarter about where we come out and the studies that we're initiating.

Andy Hsieh -- William Blair -- Analyst

Got it. Okay. That's very clear. Thank you, Mark. And then, I guess, looking back at ESMO, I think HER2 is one of the conference winners in terms of compelling data sets. I'm just curious about your take on the optimizations done there and kind of any read through to IMGN151, the next-generation asset.

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

So, Andy, if you could clarify what you're thinking, so you're talking about in HER2 that you choose HER2 ADC with campa season [Phonetic] and you're thinking about how that builds upon the success of Kadcyla and you're asking an analogue for how might IMGN151 build on the success of mirvetuximab, is that what you're driving at?

Andy Hsieh -- William Blair -- Analyst

Yeah. That and also, I guess, for -- and HER2 is basically two sides of optimization, right? So basically the linker and the payload. And I believe IMGN151 are all different components were optimized, so just curious about kind of that lead through the clinical benefits derived from two optimization versus theoretically the race for IMGN151?

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

Yeah, sure. So, we're always innovating. And so, the innovations that we've built into IMGN151 includes the antibody is a biparatopic. So, you're buying two separate epitopes and folate receptor alpha, which we've shown leads to more internalization events and more cell killing. And that translates into being able to target tumors with broader expression of FR-alpha, so that we see activity -- very nice activity for IMGN151 in low and medium levels of FR-alpha expression in vitro and in vivo. And so, IMGN151 is really designed to address a broad range of FR-alpha positive tumors, including essentially almost all of ovarian cancer as well as and moving into endometrial cancer, triple negative breasts and lung cancer.

And you're right, the linker payload has also been innovated on in terms of having a more stable linker payload that's even more stable in circulation than mirvetuximab, the payload itself is a bit more hydrophobic, a bit more potent and has a bit more bystander killing. So, we're really excited to be on track to file the IND before the end of the year for IMGN151 and get that into the clinic early next year.

Andy Hsieh -- William Blair -- Analyst

Okay. That's very helpful. Thank you.

Operator

Our next question comes from Kennen MacKay from RBC Capital Markets. Your line is open.

Kennen MacKay -- RBC Capital Markets -- Analyst

Hi. Thanks for taking the question. I'm looking forward to the SORAYA data. Maybe with the SORAYA data really moving ahead here, just wanted to get your current perspective on sort of the bar for accelerated approval again, as it relates to overall response rates as well as the confidence intervals associated with the overall response rate, whether that overall response rate itself is more important or non-overlapping confidence intervals there with standard of care?

And then, secondarily, I just wanted to -- housekeeping question here, just wanted to see if the folate receptor-alpha diagnostic would be ready to be filed alongside mirv with SORAYA successful in Q1 there? Thank you.

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

Sure, Kennen. So, the guidance that we got from FDA is that we need to exclude 12%. So what that means is the lower band is the 95% confidence interval needs to be above 12% to be considered a statistically positive study. And certainly, the larger the sample size, the narrower the confidence interval. And so, as a reminder, we had 70 patients where we demonstrated a confirmed overall response rate of 31.4%. The lower band of that confidence interval was 20.9%.

And the SORAYA study is actually a bit bigger, right? It was designed to be about 100 and 105 patients. So, again, the confidence interval will be appropriate for that size study. So, again, that's in terms of statistical significance. In terms of what's clinically meaningful to physicians and patients would be a doubling of response rate from what you get expected with standard of care single agent chemotherapy, which again is 12%.

Turning to your second question regarding the companion diagnostic, we've been working with Ventana since the inception of the mirvetuximab program and we anticipate that the CDx will be available contemporaneously with the drugs. We've already -- Ventana has already filed some of the components of the PMA. So we're on track there.

Kelly Shi -- Jefferies -- Analyst

Our next question comes from Kelly Shi with Jefferies. Your line is open. Congrats on all the progress and thank you for taking my questions. So far, SORAYA trial, the protocol allows PARP inhibitor treatment. I wonder like if they are estimated what percentage of the patients actually had PARP inhibitor treatment? And also, a follow-up question is, given the difference of prior treatments, Avastin and Erbitux compared to FORWARD I, what do you think the impact of both these agents in the background more of treatment efficacy? Thank you.

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

So, over the past several years, PARP have been adopted and incorporated into the treatment of ovarian cancer. In the FORWARD I study, which was performed at the time that the initial approvals and the treatment setting were being done and just the maintenance trials were ongoing, about 10% of patients had a prior PARP inhibitor. With each subsequent cohort that we have enrolled since then, with all of our combination studies, the percent of patients who have had a prior PARP inhibitor has increased to about 35% to 40% over time with the most recent publicly reported cohort.

And what we've seen is a consistent and continued efficacy of mirvetuximab regardless of prior PARP use or not. And you may recall that the mechanism of action for PARP inhibitors, they interfere with the tumor cells ability to repair DNA damage and our drug is a tubulin-directed inhibitor. So there's no reason actually to anticipate cross resistance between these mechanisms.

Kelly Shi -- Jefferies -- Analyst

Great. Thank you.

Operator

[Operator Instructions] Our next question comes from Jessica Fye with JPMorgan. Your line is open.

Daniel Silver -- JPMorgan -- Analyst

Good morning, everyone. This is Daniel [Phonetic] for Jessica Fye. Thank you for taking my question. For SORAYA, in the event that you rule out the 12% overall response rate with chemo and analysis using the blinded independent central review, but it comes in below the doubling of chemo you've just suggested would be clinically meaningful. Maybe can you talk about what that scenario would mean for approval and for the commercial opportunities for Merck/Texoma?

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

So, again, we believe that a doubling of response rate would be considered clinically meaningful. And that 12% benchmark is based on investigator set assessments from AURELIA. So, we will have both datasets. FDA will review both datasets, and it's really about the overall benefit risks, so one is the benefit. So, what is the response rate and what's the duration of those responses compared to available therapy. And also turning to risk. You may recall from the FORWARD I study mirvetuximab has a very nice tolerability profile with fewer dose reductions due to drug-related adverse events and fewer discontinuations. So, again, FDA will have both datasets to assess the overall benefit risk. But from a study perspective, it's about ruling out a 12% overall response rate for the primary endpoint.

Mark Enyedy -- President and Chief Executive Officer

Then, as it relates to the commercial opportunity, Anna has said, something clinically meaningful here would be to double the response rate versus standard of care and have somewhat longer duration of response than what we see reported. And I think when you look at the real world evidence in these patients, 12% actually is an optimistic response rate as we think about additional studies that have been done here.

So, we think with this profile, that mirvetuximab will displace single agent chemotherapy. And as you think about the market opportunity here, when we look at second through fourth line platinum-resistant disease here in the US, each year there are roughly 22,000 patients who are available for treatment and just under 50% of those patients get single agent chemotherapy. So that will be our target indication, of course, with the cut for patients who express folate receptor alpha at high levels, which is about 40% of the patient population. So we think that between SORAYA and MIRASOL, we're looking at about 4,200 patients per year.

Daniel Silver -- JPMorgan -- Analyst

Okay. Thank you. And then, maybe a quick follow-up. I know it might be a little bit early, but in terms of the overall response rate that will be shown in the label, is it -- will it be based on investigator assessment or will it be based on the bigger assessment?

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

So, investigator assessment is the primary endpoint for our study. If you look at labels for other drugs that are approved in ovarian cancer, some of them have investigator assessments, some of them have independent assessment and some labels have both. So we look forward to discussing with the FDA during label negotiations.

Daniel Silver -- JPMorgan -- Analyst

Great. Thank you very much.

Operator

Our next question comes from Jonathan Chang with SVB Leerink. Your line is open.

Jonathan Chang -- SVB Leerink -- Analyst

Good morning. And thanks for taking my questions. First question, can you discuss your views regarding mirvetuximab into earlier line ovarian treatment settings? Specifically what are your thoughts on the maintenance setting?

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

Yeah. So maintenance has certainly become a part of ovarian cancer treatment and it's really changed the paradigm for patients now as PARP inhibitors are being adopted, as well as with bevacizumab it's a little bit longer, both in the recurrent platinum-sensitive setting and the frontline setting. And then, most recently, with the PAOLA study where the combination of Olaparib plus bevacizumab is really quite helpful for patients, particularly the HRD patients.

So, we're really excited about the potential for mirvetuximab as a maintenance option. Knowing the safety profile of mirvetuximab monotherapy, we have had some patients on for well over a year, two years, even three. And also, the combination for mirvetuximab plus Bevacizumab, you may recall are really nice data in over 120 patients now with very nice progression free survival duration of response data and having patients on for many, many cycles. So we believe that mirvetuximab absolutely has potential to be incorporated into the maintenance treatment paradigm. And as you've heard from Mark, we look forward to sharing our label expansion strategies for combinations next quarter.

Mark Enyedy -- President and Chief Executive Officer

Yeah. Maybe just to add one point there. I mean, there's two elements to this. The first is continuation of therapy. So, for example, when we think about carboplatin, the first patients we enrolled got their normal six to eight cycles of carbo and then they simply continued on mirvetuximab therapy. And as we said, we reported out small numbers, but progression free survival about 15 months. Separately, you could imagine combining mirvetuximab with Avastin in a maintenance protocol, so having received something else as an induction therapy to generate a response and then adding mirvetuximab to that. So we're working through those points as we speak and will be part of the discussion that we have next quarter.

Jonathan Chang -- SVB Leerink -- Analyst

Understood. Thank you. And second question, can you provide any color on how the IMGC936 dose escalation has progressed? Should we expect data in the early part of next year?

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

Yeah. So IMGC936 is our ADAM-9 targeting ADC and it has our next-generation maytansinoid payload DM21. ADAM-9 is widely expressed across a variety of solid tumors. And so, we're doing a dose escalation study 3+3 in those tumors that we know express ADAM-9, including triple negative breast cancer, colorectal lung cancer, pancreatic and gastroesophageal. So, I would say that that Phase 1 dose escalation is going as anticipated. And we look forward to sharing data in 2022. I don't think I can give more timing at the moment, but we'll update it certainly as we get closer.

Jonathan Chang -- SVB Leerink -- Analyst

Got it. Thanks for taking the questions.

Operator

Our next question comes from RK Ramakanth with H.C. Wainwright. Your line is open.

RK Ramakanth -- H.C. Wainwright -- Analyst

Thank you. Good morning, folks. So let me add my question on mirvetuximab as well. In terms of MIRASOL enrollment can you give us any color as to where it is at this point?

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

So MIRASOL is enrolling and we're on track to have data Q3 next year.

RK Ramakanth -- H.C. Wainwright -- Analyst

Okay. And then, on IMGN632, what sort of data expectations should we have for the combination in terms of like what sort of efficacy endpoints or safety that you would be putting out?

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

Thank you for asking, RK. We're quite excited about ASH. IMGN632 is our CD123-targeted ADC that we are in combination with azacytidine and venetoclax. And we're looking forward to our presentation where we will share initial safety and anti-leukemia activity for the triplets. So, stay tuned. I think the abstracts will be out November 4,

RK Ramakanth -- H.C. Wainwright -- Analyst

Yes, yes. I'm aware of that. And then on CADENZA, again, I know you have it in your slides as to when the data is expected, but how should we think about that data and on top of what we're going to see at ASH? How are you planning to build that up so that we can try to understand how this drug is working, not only as a monotherapy, but also as a combination therapy?

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

So, IMGN632 is being studied in BPDCN, both relapsed refractory BPDCN and in an enrolling pivotal frontline BPDCN cohort after we've received breakthrough therapy designation from FDA in the relapsed refractory setting. We're also exploring IMGN632 as monotherapy in an MRD positive cohort. That cohort is open to any AML patient who is MRD positive after their prior therapy. So it could be after frontline induction or it could be later line. And1 so, we look forward to sharing data at ASH for BPDCN for, I would say, a handful of patients who are frontline. We've talked about them in the past. There are three frontline patients who received IMGN632 prior to us commencing the official pivotal cohort in the frontline setting and we've shared in the past that each of those patients have had a CRC. We look forward to sharing additional details around those three patients.

RK Ramakanth -- H.C. Wainwright -- Analyst

Thank you, Anna. Thank you very much, folks. And I'll talk to you guys soon.

Mark Enyedy -- President and Chief Executive Officer

Thanks.

Operator

Our next question comes from Joe Catanzaro with Piper Sandler. Your line is open.

Joe Catanzaro -- Piper Sandler -- Analyst

Hey, guys. Thanks so much for taking my question. Maybe one quick one from me just following up on MIRASOL. Just wondering how we should think about how the SORAYA response rate and DOR translates to MIRASOL and maybe just sort of directionally where you think it would head in MIRASOL based on the SORAYA data? Thanks.

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

So, SORAYA and MIRASOL are quite similar patient populations, Joe. The difference is that in MIRASOL patients may or may not have had prior bevacizumab, whereas in SORAYA every patient has had prior bevacizumab. However, it's the same number of lines of therapy 1 to 3 prior lines of therapy. And you may recall in the FORWARD I study about half of the patients had prior bevacizumab. We anticipate a similar percentage of patients in MIRASOL having prior bevacizumab. But remember, in MIRASOL, the primary endpoint is progression free survival. And of course, we will be looking at overall response rate in the MIRASOL study as well.

So, I think that gives you a sense of the patient populations and I think you will be able to think about how MIRASOL may play out taking into consideration both the SORAYA data that we will share this quarter, as well as the prior FORWARD I dataset.

Joe Catanzaro -- Piper Sandler -- Analyst

Okay, thanks. That's helpful. Thanks for taking my question.

Operator

Our next question comes from Boris Peaker with Cowen. Your line is open.

Boris Peaker -- Cowen -- Analyst

Great. Sorry, I joined a few minutes late if you may have addressed this, but for the AML data update later at ASH, what you consider successful data and considering the competitive dynamics in the AML space?

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

Yeah. So, CRI rates are really important in AML, in relapsed/refractory AML. And for a combination, we think CR/PR rates, something in the rate of 30% to 40% would be quite clinically meaningful and would support further development.

Boris Peaker -- Cowen -- Analyst

Got it. And so, my last question is for IMGN632. If the data achieves that threshold, what is the timeline for future development? And we do have to do a randomized study and if so, how long would something like that take?

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

Given the high unmet need in relapsed/refractory AML, many combinations and single agents are used and none of them are really outstanding. There is the potential for a single arm study to support accelerated approval. And ultimately there's also a potential for a frontline randomized study. But I think it's a little early for us to really start getting into timing of what the pivotal registration trial or trials would be for the combinations. We really are looking forward, however, to sharing the initial combination data for the triplet at ASH.

Boris Peaker -- Cowen -- Analyst

Great. Thanks for taking my questions.

Operator

There are no further questions at this time. I'd like to turn the call back over to the team for any closing remarks.

Mark Enyedy -- President and Chief Executive Officer

Great. Thanks very much. I very much appreciate you joining us this morning and obviously, we have a big quarter yet ahead of us. So like you, we await the SORAYA data with great anticipation and we're on track to deliver that data this quarter. And then separately with IGMN632 important data at ASH, and then finally IMGN151, we expect to file the IND for that program before the end of the year. So, stay tuned and we will look forward to sharing digital data with you over the course of the quarter. Thanks.

Operator

[Operator Closing Remarks]

Duration: 35 minutes

Call participants:

Courtney O'Konek -- Senior Director, Corporate Communications and Investor Relations

Mark Enyedy -- President and Chief Executive Officer

Anna Berkenblit -- Senior Vice President, Chief Medical Officer

Susan Altschuller -- Senior Vice President and Chief Financial Officer

John Newman -- Canaccord Genuity -- Analyst

Michael Schmidt -- Guggenheim -- Analyst

Andy Hsieh -- William Blair -- Analyst

Kennen MacKay -- RBC Capital Markets -- Analyst

Kelly Shi -- Jefferies -- Analyst

Daniel Silver -- JPMorgan -- Analyst

Jonathan Chang -- SVB Leerink -- Analyst

RK Ramakanth -- H.C. Wainwright -- Analyst

Joe Catanzaro -- Piper Sandler -- Analyst

Boris Peaker -- Cowen -- Analyst

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