Image source: The Motley Fool.
Macrogenics Inc (MGNX -3.27%)
Q4Â 2019 Earnings Call
Feb 25, 2020, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good afternoon. We will begin the MacroGenics 2019 Fourth Quarter Corporate Progress and Financial Results Conference Call in just a moment. [Operator Instructions]. And we will conduct a question-and-answer session at the conclusion of the call. At this point, I would turn the call over to Anna Krassowska, Vice President, Investor Relations, and Corporate Communications of MacroGenics.
Anna Krassowska -- Vice President, Investor Relations and Corporate Communications
Thank you. Good afternoon, and welcome to MacroGenics' conference call to discuss our fourth quarter 2019 financial and operational results. For anyone who has not had a chance to review our results, we issued a press release this afternoon outlining today's announcements, which is available under the Investors tab on our website at macrogenics.com.
You may also listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately two hours after the call is completed. I would like to alert listeners that today's discussion will include statements about the Company's future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our annual, quarterly and current reports filed with the SEC. In addition, any forward-looking statements represents our views only as of today and should not be relied upon as representing our views as of any subsequent date.
While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change, except to the extent required by applicable law.
And now, I'd like to turn the call over to Dr. Scott Koenig, President and Chief Executive Officer of MacroGenics.
Scott Koenig -- President and Chief Executive Officer and Director
Thank you, Anna. I'd like to welcome everyone participating via conference call and webcast today. Thank you for joining us. This afternoon, I will provide an update on our clinical programs and the advancement expected during the year. But before I do so, let me first turn the call over to Jim Karrels, Senior Vice President and Chief Financial Officer, who will review our financial results for the year.
James Karrels -- Senior Vice President, Chief Financial Officer and Secretary
Thank you, Scott. This afternoon, MacroGenics reported financial results for the year ended December 31, 2019, which highlight our financial position as well as our recent progress. As described in our release, MacroGenics had research and development expenses of $195.3 million for the year ended December 31, 2019, compared to $190.8 million for the year ended December 31, 2018.
This increase was primarily due to the continued enrollment across our multiple ongoing clinical trials. We had general and administrative expenses of $46.1 million for the year ended December 31, 2019, compared to $40.5 million for the year ended December 31, 2018.
This increase was primarily due to an increase in consulting costs related to market research and other commercial preparation activities. Consistent with our prior communications, we have no intention to build out a sales force at this time as our strategy remains to partner the commercialization of margetuximab. Nonetheless, there is a modest preparatory investment in pre-commercial efforts that we believe may be necessary.
We recorded total revenue, consisting primarily of revenue from collaborative agreements of $64.2 million for the year ended December 31, 2019, compared to $60.1 million for the year ended December 31, 2018. This increase was primarily due to the timing of revenue recognition under our collaborative agreements. Included in our 2019 total revenue was $24.3 million recognized under various supply agreements with our collaboration partners, including Incyte Corporation and Zai Lab, with regard to our development and manufacturing activities that support supply of partnered product candidate drug material.
I will also point out that of the $25.4 million in other income we recognized for the year ended December 31, 2019, approximately $20 million related to both the revaluation of warrants we received as consideration under license and purchase agreements with Provention Bio and the gain on sale of the underlying 1.95 million shares of Provention Bio mostly during the fourth quarter. We had a net loss of $151.8 million for the year ended December 31, 2019, compared to net loss of $171.5 million for the year ended December 31, 2018.
And finally, our cash, cash equivalents and marketable securities as of December 31, 2019, were $215.8 million compared to $232.9 million as of December 31, 2018. We anticipate that our cash, cash equivalents and marketable securities as of December 31, 2019, combined with anticipated and potential collaboration payments will enable us to fund our operations into 2021 assuming our programs and collaborations advance as currently contemplated. Through the prioritization of programs and ongoing realignment of resources, we are focused on extending our cash runway into 2022.
And now I'll turn the call back to Scott.
Scott Koenig -- President and Chief Executive Officer and Director
Thank you, Jim. As we outlined in January, as the product candidates in our pipeline advance toward later-stage trials, we are prioritizing those programs that we believe have the highest scientific and commercial merit as well as potential to achieve regulatory approval. As I will describe later in more detail, we took several actions to prioritize and focus. We discontinued development of two clinical stage molecules, MGD007 and MGD009. Going forward, we expect to pursue only focused dose expansion cohorts in one or two tumor types for each molecule currently in Phase I dose escalation.
We prioritize Module A of the Phase II/III MAHOGANY study, and we modified the design of the planned Phase II/III registration-directed study of enoblituzumab. Let's begin with margetuximab, our investigational FC-engineered anti-HER2 antibody. In December 2019, we submitted a biologics license application, or BLA, to the FDA for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy.
The safety and efficacy results provided in the BLA are primarily from the pivotal Phase III SOPHIA study, which is evaluating margetuximab plus chemotherapy, compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer who have received prior anti-HER2 therapies. Updated results from the study were presented at the San Antonio Breast Cancer Symposium in December 2019.
Recently, the BLA was accepted for review by the FDA. Accordingly, we expect the standard review process with an anticipated Prescription Drug User Fee Act or PDUFA date by the end of 2020. We also expect that the FDA will require an Oncologic Drugs Advisory Committee, or ODAC committee, in the second half of 2020. Separately, in February 2020, a regional partner in Greater China, Zai Lab, announced that they initiated a bridging study to support the potential registration in Greater China of margetuximab plus chemotherapy for the treatment of patients with metastatic HER2-positive breast cancer.
Beyond breast cancer, we have initiated the Phase II/III MAHOGANY study in first-line patients with advanced HER2-positive Gastric or Gastroesophageal Junction cancer. Initially, MAHOGANY is evaluating margetuximab plus MGA012, our investigational anti-PD-1 antibody licensed to Incyte in patients with HER2 IHC 3+ and PD-L1 double positive disease. The single-arm part of MAHOGANY study, which we refer as Module A is designed to support a potential accelerated approval of margetuximab plus, MGA012 in the United States based on a primary efficacy endpoint of objective response rate.
We believe that this chemo-free regimen, which engages both innate and adaptive immunity may be significant opportunity to change the treatment paradigm for patients living with advanced HER2-positive gastric cancer. In the second half of 2020, we expect to assess initial safety and efficacy data of the ongoing MAHOGANY Module A to inform a go no-go decision on further enrollment.
As a reference, a response rate of 47%, with a median overall survival of 13.1 months was reported from the TOGA study that evaluated chemotherapy in trastuzumab in first-line advanced HER2-positive gastric cancer. At ESMO in September 2019, we presented data from our second line Phase II study of margetuximab plus pembrolizumab. We observed a median overall survival of 20.5 months and a response rate of approximately 50% among patients whose tumors are HER2 IHC 3 positive and PD-L1 double positive.
Notably, the safety profile of margetuximab and pembrolizumab observed in our study in which Grade 3 or greater treatment-related adverse events were reported in approximately 20% of patients was comparable to the historically observed with pembrolizumab monotherapy. We believe this compares favorably against a 68% grade 3 treatment-related adverse event rate reported in the TOGA regimen.
The second component of the MAHOGANY study, which we refer to as Module B is designed as a randomized controlled trial to evaluate the combination of margetuximab with chemotherapy plus either MGA012 or MGD013, our PD-1 by LAG-3 DART molecule compared to trastuzumab in chemotherapy in a broader population of patients with advanced HER2-positive gastric cancer. The study is designed to evaluate overall survival as the primary endpoint.
We expect Zai Lab to lead the initiation of the Module B in Greater China in the second half of 2020. The next program I will discuss is flotetuzumab, our investigational bispecific DART molecule that recognizes both CD123 and CD3. At the American Society of Hematology or Ash Annual Meeting in December 2019, we presented updated results from the patients with AML who are refractory to induction therapy in the ongoing Phase I/II dose expansion study.
Of the approximately 20,000 patients diagnosed with AML in the United States annually, at least 30% fail to achieve a CR with an intensive induction therapy. These patients represent an extremely challenging population to treat where based on our data, we believe there may be an opportunity to address this unmet need. We intend to find a potential registration path for flotetuzumab in the United States in the first half of 2020, pending continued discussions with the FDA.
We have also initiated outside the United States, a combination study of flotetuzumab and MGA012 in relapsed or refractory AML patients as a potential means to both broaden and lengthen the duration of response of AML patients on flotetuzumab. The combination is supported by a strong scientific rationale based on data that we have previously reported.
Let me next turn to MGA012, our investigational anti PD-1 antibody, which is exclusively licensed to Incyte Corporation globally, although we retain the rights to develop our pipeline product candidates in combination with this molecule. Incyte is initially pursuing development on MGA012 monotherapy through potentially registration-enabling studies in anal cancer, MSI-high endometrial cancer and Merkel cell carcinoma with data in anal cancer anticipated in the second half of 2020.
In addition, we expect Incyte to initiate two Phase III studies of MGA012, known as POD1UM-301 and POD1UM-304 in patients with advanced or metastatic non-small cell lung cancer. In all, there are currently six registration-directed clinical studies ongoing or planned in 2020 across a broad range of tumor types. Our second checkpoint molecule is MGD013, a first-in-class investigational bispecific DART molecule targeting PD-1 and LAG-3. MGD013 is being evaluated in the Phase I dose expansion study from which we are selecting one or more indications for further development.
In addition, we have submitted data from select cohorts in the ongoing study for presentation and a scientific conference in the first half of 2020. Separately, in February 2020, MacroGenics' regional partner in Greater China, Zai Lab announced the initiation of a Phase I study of MGD013 in combination with Niraparib, a PARP inhibitor for the treatment of patients with advanced gastric or gastroesophageal junction cancer. Let me now briefly discuss enoblituzumab, our investigational FC-engineered anti-B7-H3 monoclonal antibody.
To further inform the development of enoblituzumab, we decided to modify the previously planned Phase II/III study and take the opportunity to test whether we could achieve greater antitumor activity by combining enoblituzumab with dual PD-1 and LAG-3 checkpoint blockade. We, therefore, plan to initiate a lead-in module to evaluate the activity of both enoblituzumab plus MGA012, and enoblituzumab plus MGD013 as chemotherapy-free regimens in first line patients with recurrent and metastatic head and neck cancer before proceeding with one of these combinations in a future Phase II/III study.
Finally, in 2020, we anticipate completing Phase I dose escalation of MGC018, our antibody drug conjugate targeting B7-H3, as well as for MGD019, a bispecific DART molecule targeting PD-1 and CTLA-4. We plan to submit data from the dose escalation cohorts for both molecules for presentation at scientific conferences in 2020.
In addition, once we complete dose escalation, we are planning to initiate a focused dose expansion study for each molecule in one or more select tumor types. While the initial data sets are small, we are encouraged by the progress in these studies to date, and we look forward to sharing data from both of these programs in 2020. In summary, 2019 was an important year for MacroGenics with the submission of our BLA for margetuximab for HER2-positive breast cancer. Margetuximab is also being evaluated in combination with checkpoint blockade in a registration-directed clinical study in advanced HER2-positive gastric cancer.
During 2020, we anticipate additional key events. We intend to define a registration path for flotetuzumab in refractory AML, pending further discussion with the FDA. We also look forward to presenting initial clinical data from several of our Phase I programs including MGD013, MGD019 and MGC018. With these milestones, we anticipate a productive year ahead and look forward to continued progress. We would now be happy to address any questions that callers may have.
Operator?
Questions and Answers:
Operator
[Operator Instructions]. The first question comes from Debjit Chattopadhyay of H.C. Wainwright. Your line is open.
Earl DeSouza -- H.C. Wainwright -- Analyst
This is Earl DeSouza in for Debjit. Can you hear me?
Scott Koenig -- President and Chief Executive Officer and Director
Yes. Hi, Earl.
Earl DeSouza -- H.C. Wainwright -- Analyst
Hey. So, a couple of questions from my end. The first is on MGA013. When should we expect that data? Is that more at AACR or ASCO event? And additionally, what threshold of activity do you think is both compelling and convincing from single-arm study? The second question we have is regarding the BLA acceptance. And you guys -- you mentioned something about the commercial launch, and wanted to know how do you see this adoption of marge in the post DS-8201 world.
And if we could squeeze one more, it's regarding flotetuzumab. Any further updates on the regulatory dialogue? And is the plan still a single-arm expansion core in primary refectory patients as a registration study? Thank you so much.
Scott Koenig -- President and Chief Executive Officer and Director
Thanks so much, Earl. So MGD013, PD-1 by LAG-3, we submitted abstracts to ASCO. Obviously, we'll have to wait to hear the response. But given the content we placed in the abstract, which included the dose escalation of the molecule as well as expansion into multiple cohorts composed of nine different tumor types where we've treated over 150 patients, we expect, obviously, opportunity and forum to present that data.
With regard to the specific threshold that we would expect to be acceptable, it varies greatly from tumor to tumor. What we've incorporated in this study are to patients that have received previous checkpoints, ones that were naive to checkpoint treatments. In some cases, we've also had some limited studies in combination therapy. So it varies from tumor to tumor type. And so you'll have to wait until the meeting to assess that data set.
With regard to the second question, the BLA acceptance and commercial launch. And how you think this -- how we think this will be adopted in the post 8201 world. As we have shown previously and discussed the merits of margetuximab, we're actually very excited for the opportunity for patients to have access to a molecule like margetuximab, obviously, if it gets approved by the FDA. First of all, this is the only head-to-head study that has ever been tested against trastuzumab and having shown successfully in a statistically significant manner a PFS benefit of this molecule, and trending in the OS benefit of margetuximab over -- margetuximab over trastuzumab.
We think it gives the -- both the patient and the treating physician a great opportunity to give the patient a better treatment selection. In particular, given that this was tested in four different -- in combination with four different chemotherapies, depending on the historical treatment regimens these patients have received, it gives optionality where they may not have it under other conditions. And we expect, in the case of 8201, while the response of patients was quite remarkable, unfortunately, many of these patients will progress on their treatments. And as a result, will need additional options.
With regard to flotetuzumab, and updates in the regulatory dialogue. As we had previously noted, we had an interaction with the FDA this past September. We discussed the opportunity to devise a clinical plan focused on the refractory population. The FDA agreed with us that this is a population where there is a clear need. They had asked us for additional data, which we're supplying to them, expect to have some additional dialogue in the first half of this year. And our plan is to be able to update everyone by midyear on those discussions and next steps going forward.
In the interim, we are continuing to enroll patients using the dosing regimens that we discussed at ASH in December to increase the number of patients that could potentially benefit from flotetuzumab. With regard to the design of the specific study, clearly, a single-arm study would be optimal, given that these patients have failed multiple lines of high-dose chemotherapy and hypomethylating agent treatment as well as directed therapy. But again, this will be a part of the conversation we have with the FDA in the ultimate design of the molecule.
Earl DeSouza -- H.C. Wainwright -- Analyst
Thank you so much, Scott.
Operator
Thank you. Our next question comes from Varun Kumar of Cantor Fitzgerald. Your line is open.
Varun Kumar -- Cantor Fitzgerald -- Analyst
Hey, good evening everyone and thanks for taking the questions. First on flotetuzumab. Any regulatory discussion ongoing around safety profile and specifically around the leading dosing strategy. Scott, if you can provide some color there?
Scott Koenig -- President and Chief Executive Officer and Director
So there's been multiple conversations over the years with regarding the dosing strategy. And clearly, as you have seen, the evolution of this molecule, we have evolved this strategy so that we've optimized the lead in dosing in the first week of treatment to achieve the targeted dose of 500 nanograms per kig in subsequent treatment during the three weeks of the first cycle of therapy.
We've also implemented in the subsequent cycles of therapy, a continued dosing of the drug. We have found that if you do not interrupt dosing, the likelihood of having any further cytokine release associated with drug is dramatically reduced. And we have seen that this is a very favorable profile for the drug. So, so far, we will -- nothing further to discuss with regard to the safety profile. We are continuing to provide additional data, which includes the safety analysis of patients that have been treated historically and are ongoing treatments. But we expect, obviously, to have that as part of our updated discussion with the FDA shortly.
Varun Kumar -- Cantor Fitzgerald -- Analyst
Thank you, Scott, and I wanted to follow-up on 013, the PD-1 LAG-3 program. Given two targets, PD-1 and LAG-3, I just wanted to understand if there will be supporting data at the conference when you present the initial data, which can potentially highlight contribution coming from PD-1 or LAG-3.
Scott Koenig -- President and Chief Executive Officer and Director
So in that regard, we don't have, obviously, a separate LAG-3 antibody, this is a composite molecule. We're evaluating these both in checkpoint or anti-PD-1 or anti-PD-L1 experienced patients as well as naive patients. What we will try to do, and -- I don't know by the time ASCO occurs, whether we have a full comprehensive data set, we are analyzing specimens for varying levels of LAG-3 expression in patients treated, and we'll try to, obviously, come to some conclusions with the value of either threshold levels of LAG-3 expression or ultimate percentage of LAG-3 the expression in the tumors and its association with ultimate responsiveness. I think that's probably the best we'll be able to provide in this time frame.
Varun Kumar -- Cantor Fitzgerald -- Analyst
Thank you very much, Scott. And maybe last one, if I may, on the financial guidance. You talked about the cash runway could go into 2022. Going forward, should we expect any advanced program to be impacted by reprioritizing different programs to extend the cash runway?
Scott Koenig -- President and Chief Executive Officer and Director
Well, again, obviously, we can anticipate everything in the future. But I think as we've laid out just before the J.P. Morgan meeting, a prioritization of the program, taking into account timing for the enrollment rates for the various programs. As I think we've highlighted, the focus on the Module A in the gastric study and a delay in the Phase II/III study for inotuzumab, has afforded us additional cash to continue with our programs.
As Jim has pointed out, through 2021, and as we're hoping, as we analyze the spend over the course of the next few months, that this may allow us to get into 2022. So at this point, we don't see any further need to modify the plans for the studies going forward.Thank you very much Scott. And congrats on the progress.
Varun Kumar -- Cantor Fitzgerald -- Analyst
Thank you.
Operator
Thank you. Our next question comes from Jonathan Miller of Evercore.
Jonathan Miller -- Evercore ISI -- Analyst
Hi guys. Thanks so much for taking my question and congrats on the recent progress. I would like to focus first on the MAHOGANY trial. You said initial data second half of this year. Is your expectation that, that potentially registrational ORR. I'm assuming Module A, is as good as you hope it is. Would we get that potentially registrational ORR in second half this year or some other lesser update?
Then I'd like to ask about the PD-1 CTLA-4 bispecific, which I think is an interesting one that seems to be down your list of priorities. What's your -- what are your next steps there? And is it possible we'll see that dose escalation data maybe at ASCO this year alongside the PD-1 LAG-3 bispecific. Last thing, I guess, I'll ask for is any other plans in the flotetuzumab PD-1 combo?
You've mentioned you're doing that study ex US, but you had said on the Q3 call that, that could potentially expand and become a larger program. What are your next steps with flote combos as we look forward to FDA meeting for the monotherapy?
Scott Koenig -- President and Chief Executive Officer and Director
Thanks for those questions, Jon. So with regard to MAHOGANY, we just began late last year to enroll in that study. What we are selecting is -- as you know, in that Module A is the HER2 3+ by IHC, PD-L1 positive 1% or greater. Obviously, there's some degree of screening failures. We are expanding the number of sites going forward. As noted in our various briefing books, our initial goal that we had laid out was to enroll up to 40 patients to be able to make an assessment whether we're hitting the target of overall response. And what we have put out previously is that we like to, obviously hit what TOGO is in terms of overall response rate or greater.
Just to refresh your memory, it was about 47% in the TOGO regimen and, obviously, have a better safety profile. We think that with less than 40 patients, we'll be able to make the assessment of whether the response rate is adequate enough to try to accelerate the continued enrollment through 2021. If we hit those milestones, we feel that we can get that fully enrolled by the end of 2021. But clearly, we're off to a good start this year. It obviously takes time to continue to evaluate the patient and observe them. So clearly, the hope is that in the first half of this year, we will enroll enough patients to be able to make that decision in the second half of this year.
With regard to the PD-1 CTLA-4 priorities and dose escalation and are we going to present it at ASCO? What I mentioned just before J.P. Morgan Meeting, we had done a dose escalation of the molecule. Our targeted top dose was 10 migs per kig. We achieved that quite successfully. We've seen objective responses in the multiple tumor types. And so with a very good safety profile now that seems quite comparable to single anti-PD-1 therapies. We obviously want to get a broader experience now with this molecule in -- at the highest dose.
We're also exploring different biomarkers that may give us insights on further future activity of this molecule. Our plan is completing out this dose escalation study with expansion with multiple tumor types, sort of an all-comers study. And then subsequently pick one or a maximum of two tumor types that we will expand into. We did not submit an abstract to ASCO for this, but we are planning probably in the second half of the year, providing at a scientific meeting the data that we've generated to date and will continue to generate over the next few months.
With regard to flotetuzumab, the ongoing study with anti-PD-1 is ongoing in three countries. It's in Australia, Spain and Israel. We are in various dose escalation phases of that study. We start out with a little lower doses to make sure that we didn't see a increased safety signal, which we haven't seen to date. Our plan is to continue to expand in those countries. And it is our plan also to eventually get US sites involved as well. It's something that we intend to do in this year. So that's kind of where we are with that molecule.
Jonathan Miller -- Evercore ISI -- Analyst
Great. Thank you very much.
Operator
Thank you. Our next question comes from Christopher Marai of Nomura Instinet. Your line is open.
Christopher Marai -- Nomura Instinet -- Analyst
Hey, thanks for taking the question. Just one for me here on MGC018, your B7-H3 ADC. I was wondering if you could further elaborate on the type of data that we might see here from the initial dose escalation. Obviously, some safety and then maybe the potential chance for efficacy data.
But with regard to safety, could you also perhaps help us understand the toxicities you might expect from the payload that you're using there? And sort of help set up our expectations around that. Thank you.,
Scott Koenig -- President and Chief Executive Officer and Director
Thanks, Chris. So with regard to where we are on this molecule, as I had outlined previously in January, we went through -- while we are in the middle of dose escalation, we are in mix per kig dosing range, which was the expected range where we would begin to see biological activity, which I have indicated we have observed in different tumor types. Second is with the safety that we've seen to date, again, with a limited number of patients, it appears to be quite acceptable and tolerable.
The intended toxicities or the possible expected toxicities that one sees with this particular payload, the duocarmycin, which is incorporated in another molecule that Synthon is developing for HER2 therapy. Their major toxicity that was observed was often reported for other ADCs, which was eye toxicity keratitis and such. I have to say, we haven't seen much in terms of problems with eye to date.
And so again, our experience is on a limited number of patients. We will plan to provide update mid-year to the second half of this year on this study. And because this is an ADC molecule, single-agent activity should be expected, and we would intend to advance this forward likely in one major tumor type or possibly two.
Christopher Marai -- Nomura Instinet -- Analyst
Okay. And then regarding the tumor types that you're looking at, did you -- do you just sort of look at tumors that express B7-H3 highly? I know many do. Are there any there that MacroGenics is looking at to prioritize development in pending data? Thank you.
Scott Koenig -- President and Chief Executive Officer and Director
Rather than opening up and reveling at this point, there's -- we have our priority list, but I think it's still too early to be definitive about this. We will update this later this year.
Christopher Marai -- Nomura Instinet -- Analyst
Thank you.
Operator
Thank you. Our next question comes from Yigal Nochomovitz of Citi. Your line is open.
Yigal Nochomovitz -- Citigroup -- Analyst
Thanks very much for taking the question. On the decision to amend enoblituzumab tryout to include leading cohort through combination with MGD013 and MGD012. I wonder if you could elaborate more on some of the reasons that you believe MGD013 may potentially be a better combo with enoblituzumab? And is it known what's the expression of LAG-3 is among patients with head and neck cancer?
Scott Koenig -- President and Chief Executive Officer and Director
So yes, thank you very much for that question. That's why we're doing this lead in module testing, we have seen, as we've indicated, activity across a number of tumor types, including head and neck cancer. We had analyzed our own set of specimens, and there is also reported published work on LAG-3 expression in head and neck cancers, and it turns out they have expression in a sizable portion of the population.
So rather than diving in with the 012, given the advancement of the 013 program, we thought rather than doing a Phase II/III study and kicking ourselves afterwards for not testing 013, we thought it would be much more effective at testing one versus the other. And the other point is, is that 012, as you know, is partnered with Incyte where, except for China rights, we own 013. So again, of being able to combine two of our own molecules together, if the efficacy and safety looks more favorable than 012 would make the most sense to us.
Yigal Nochomovitz -- Citigroup -- Analyst
Thanks. That's very helpful. And then sticking to MGD013, without revealing the types of tumors that you have on your priority list, I wonder if you could just give us maybe a bit more color on what your thought process was for which of the tumor types you will be advancing? What was the threshold that you had broadly? And is there potential for monotherapy only? Or would you advance some of these tumor types as a potential combination as well?
Scott Koenig -- President and Chief Executive Officer and Director
Thanks for the question. So again, we had gone to the literature to look at levels of expression of LAG-3 across all solid tumor types as well as lymphomas. And obviously, the reported literature had varying grades of expression. We did our own pathology work in-house to evaluate a very large number of tumor sets. And in a large part, many of them were similar to what had been previously reported. What should be -- what is also interesting, just as a side, in addition to upregulation of LAG-3 free expression on immune cells, which include T-cells and NK cells, there are certain tumor types that also upregulate LAG-3 expression.
And so again, without giving you any guidance right now, we'll have to wait till data presented at ASCO. We plan to focus on specific tumors where we've seen responsiveness and correlate that with the biomarkers that we are working on in terms of IHC expression patterns. With regard to how we will proceed with this. We look at this both as monotherapy in certain tumor types, but we have also explored in a more limited fashion the combination of 013 with other molecules in our portfolio. And clearly, the opportunity here is to combine it with other modes of therapy, which include both immune therapeutics, chemotherapy and targeted agents as well.
Yigal Nochomovitz -- Citigroup -- Analyst
Thanks very much for taking the questions.
Operator
Thank you. Our next question comes from Evan Seigerman of Credit Suisse. Your line is open.
Evan Seigerman -- Credit Suisse -- Analyst
Hi guys. Thank you. Congrats on the progress last year and thank you for taking my questions. I know you touched on this a little bit before, but can you just help me better understand how you view the commercial opportunity for marge in breast cancer? And when are you going to plan -- when are you planning on kind of -- on giving us more details as to how you're thinking about partnering that out? And then a follow-up on the marge question. Can you provide us with any color as to why FDA is requiring the panel ahead of your PDUFA date?
Scott Koenig -- President and Chief Executive Officer and Director
So with regard to the commercial opportunity, we haven't given any guidance with respect to the specific targeted value end market of this molecule. Obviously, with a changing landscape now with 8201 just launched, the likelihood of [Indecipherable] being launched sometime middle of this year. We obviously have to assess what the opportunity is here. We have done our own marketing analysis. I have to say it's quite favorable from our perspective as a Company now that would be selling its -- or obviously, finding a partner to sell the first molecule. So I can't give you any more guidance on that. And I think as the market evolves this year for the other competing late-line drugs, we'll get a better sense of things.
With regard to details on partnering, we had established contacts and interactions with a number of companies that have showed interest in margetuximab. I would say that given the acceleration of the launching of the competitive molecules, and right now, given the timeliness of the regulatory review of that, I think most of them would want to see the outcomes of both those things before establishing a firm commitment to partner with us. So as I have said previously, we still engage partners from time to time on this. But we see this as a second half of the year, post ODAC review when we would get more engaged with the partnering activity.
As I -- as Jim had pointed out earlier, we've done our homework with regarding the marketing of this drug going forward. So whatever partner we end up with, we will be able to provide them with a very significant package with regard to the opportunity. As regard to the FDA panel, it's the FDA's choice to ask whatever question they want. If I were to speculate on this, is, clearly, we are still in a -- we've achieved a PFS benefit. We still have a -- we're in the -- having received the final OS evaluation for the drug, which will occur 385 events. As you know, we had a pre-planned exploratory analysis of the F allele population.
If I were to speculate, I think that would be something that the FDA might want to query with regard to the value of following that population or even limiting the drug to use in that F allele population. But I have no insight specifically on what they would query of the ODAC.
Evan Seigerman -- Credit Suisse -- Analyst
And then just follow-ups. I know you had touched on this before, but when you talk about the Module A, the Phase II/III MAHOGANY study, what type of response rates do you want to be seeing to support potential approval?
Scott Koenig -- President and Chief Executive Officer and Director
Without being specific to the precision of a single digit, clearly, we would like to achieve a response as good or better than that of TOGO, which was a 47% response rate. If you can achieve that or greater without giving a chemotherapy regimen, given the safety profile of this drug, I think that would be quite favorable. But of course, that's, again, a conversation we would have with the FDA.
Evan Seigerman -- Credit Suisse -- Analyst
All right. Thanks so much for taking the questions. I really appreciate it and congrats on the progress.
Scott Koenig -- President and Chief Executive Officer and Director
Thank you.
Operator
Thank you. Our next question comes from Stephen Willey of Stifel. Your line is open.
Stephen Willey -- Stifel Financial Corp -- Analyst
Yeah, good afternoon, thanks for taking the questions. Just a couple of questions on the Zai Lab trial. Is the incidence of the CD16A F allele carrier status the same in Chinese patients as it is in the US? And I'm guessing this is a study that's looking at efficacy as a function of intent to treat, but can you also just speak to whether or not they are also trying to carve off from a secondary endpoint perspective activity within the F allele population specifically?
Scott Koenig -- President and Chief Executive Officer and Director
Thanks for the question, Steve. Worldwide, there is minor variation in terms of CD16 allelic variation, but we're talking about a 5% or so difference from one ethnic group to another. So what we have seen in our study, which included, as you know, patients in Korea in our study, there was 86% had the F allele. So in reported literature, it goes from essentially around 80% to the 85%. So maybe some minor local variations, but I don't expect it to deviate any greatly.
The plan really from this study, as I understand it, is a bridging study to SOPHIA. So they're looking at the opportunity to treat in combination with chemotherapy and looking at response rates overall and intent to treat, but I think they also plan retrospectively to look at the F allele subsets as well. Having not seen their submissions, specifically, I can't give you any more definitive plans with regard to other secondary endpoints.
Stephen Willey -- Stifel Financial Corp -- Analyst
Okay. And then just a quick question regarding MAHOGANY. I guess if the Module A data looks to be favorable and you go ahead and proceed with additional enrollment. Have you guys done any work to look at extending marge dosing out to Q4 W. Just in an effort, I guess, to harmonize with MGA012 dosing schedule?
Scott Koenig -- President and Chief Executive Officer and Director
So we have not looked at Q4, as I recall, on marge at this point. But clearly, with regard to different dosing regimens, we are -- we have explored different dosing regimens for MGA012. And so I do believe it could fit the Q3 weekly dosing, if necessary. But right now, I know of no data on Q4 weekly for marge.
Stephen Willey -- Stifel Financial Corp -- Analyst
Okay, thanks for taking my questions.
Operator
Our next question comes from Etzer Darout from Guggenheim Securities.
Etzer Darout -- Guggenheim Securities -- Analyst
Hey, thanks for taking my question. Just one quick one. On the combination study in gastric cancer, just wondered if maybe if you can talk a little bit to the sort of the PD-1 LAG-3 neratinib study in China and whether or not there's an opportunity to extend this combination to patients outside of China?
Scott Koenig -- President and Chief Executive Officer and Director
So the -- thanks for the question, Etzer. They just filed and just started that study. Given that the rights to neratinib are in Zai's hands, and I believe the GSK is outside of China. Clearly there is opportunity there, but we don't have the ability to pursue that ourselves. So -- and clearly, there are other combinations that are being anticipated, other chemotherapies and other targeted therapies. But if that data is promising, obviously, we would yield the benefit through the Incyte relationship from the economics here on the PD-1. And clearly, if there's positive data, their other PARP inhibitors could be used in combination with it as well.
Etzer Darout -- Guggenheim Securities -- Analyst
Great, thanks for that, and congrats on all the update -- on the progress.
Scott Koenig -- President and Chief Executive Officer and Director
Thank you.
Operator
This concludes the question-and-answer session. I'll now turn the call back to Dr. Koenig for closing remarks.
Scott Koenig -- President and Chief Executive Officer and Director
I just like to thank everyone again for joining us this afternoon and to let you know that we look forward to continuing to advance our programs in the coming year and providing updates on our progress. Have a nice day.
Operator
[Operator Closing Remarks].
Duration: 53 minutes
Call participants:
Anna Krassowska -- Vice President, Investor Relations and Corporate Communications
Scott Koenig -- President and Chief Executive Officer and Director
James Karrels -- Senior Vice President, Chief Financial Officer and Secretary
Earl DeSouza -- H.C. Wainwright -- Analyst
Varun Kumar -- Cantor Fitzgerald -- Analyst
Jonathan Miller -- Evercore ISI -- Analyst
Christopher Marai -- Nomura Instinet -- Analyst
Yigal Nochomovitz -- Citigroup -- Analyst
Evan Seigerman -- Credit Suisse -- Analyst
Stephen Willey -- Stifel Financial Corp -- Analyst
Etzer Darout -- Guggenheim Securities -- Analyst
