Agenus Inc
NASDAQ:AGEN
Earnings Call Analysis
Q4-2023 Analysis
Agenus Inc
The company has made headway with its BOT/BAL program, particularly in colon cancer, citing strong clinical efficacy and sustained durability across multiple cancer types. The treatments, which are for patients with exhausted standard treatments, have been recognized by prestigious scientific forums. Securing FDA Fast Track designation for refractory MSS CRC shows promise for regulatory alignments and submissions for potential accelerated approval, starting in the US with a BLA in 2024 and in Europe with the EMA in 2025.
Agenus has benefited from its strategic collaborations, notably receiving a $25 million milestone payment from BMS for the commencement of a Phase II study. This adds to a total of $250 million received from BMS to date, and the company is exploring further opportunities to monetize assets which can potentially generate an additional $100 million to $200 million in the near term.
Agenus ended 2023 with revenues of $156 million and a net loss of $257 million. The fourth quarter alone brought in $84 million in revenue against a net loss of $49 million. With $76 million in cash at year-end and subsequent inflows like the recent $25 million milestone payment, the company expects to be sufficiently funded through 2024.
The ongoing trials with botensilimab in combination with balstilimab or chemotherapy show promising activity in treating cold tumors, offering hope for patients with limited standard options. Preliminary data is expected in the second half of this year, supporting the company's commitment to patient outcomes.
Enrollment records were broken with 230 patients in less than 5 months, sparking pharmaceutical interest in botensilimab for its broader potential beyond CTLA-4 binding, possibly leading to a robust partnership that can propel the development and regulatory journey of the product.
Agenus plans to treat a total of 60 patients, 30 on each arm of the trial, with the expansion of the lung cancer cohort to about 50 patients. The company anticipates more data in the second half of the year, as they pursue evidence to meet the criteria for potential accelerated approval by the FDA.
The company has highlighted compelling results in investigations, such as in lung cancer among EGFR mutant patients, with plans to confirm initial results for potential eligibility of accelerated approvals. There's also a commitment to exploring neoadjuvant strategies to reduce debilitating surgeries. Furthermore, data on other cancer types, including pancreatic cancer patients in randomized trials and melanoma, are expected by the end of the year, with preliminary data as early as midyear.
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Good morning. My name is Audra, and I will be your conference operator today. At this time, I would like to welcome everyone to the Agenus Inc. Fourth Quarter and Full Year 2023 Results Conference Call. Today's conference is being recorded. [Operator Instructions] At this time, I would like to turn the conference over to Zack Armen, Head of Investor Relations. Please go ahead.
Thank you, Audra, and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory and commercial plans and time lines as well as time lines for data release and partnership opportunities among other updates.
These statements are subject to risks and uncertainties, and we refer you to our SEC filings available on our website for more details on these risks. Joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer; Dr. Steven O'Day, Chief Medical Officer; and Christine Klaskin, Vice President of Finance. Dr. Robin Taylor, Chief Commercial Officer; and Dr. Todd Yancey, Chief Strategic Adviser, will be participating in the Q&A session. Now I'd like to turn the call over to Garo to highlight our progress in 2023 and to speak to our outlook for 2024. Garo?
Thank you very much. Ladies and gentlemen, today, it is with great enthusiasm that we gather to share the remarkable strides at Genesis made over the past year. Our journey has been marked by significant achievements pivotal milestones and a steadfast commitment to innovation in the field of oncology. In 2023, Agenus reached crucial milestones particularly with our BOT/BAL program and cornerstone of our operational focus. BOT/BAL therapy has undergone rigorous testing in over 900 patients. demonstrating promising activity in cancers that represented medical needs, notably colon cancer, where we are poised for potential first approval. The impressive response rates sustained durability and overall clinical efficacy observed across multiple challenging cancer types have garnered attention and excitement from leading experts in the field.
It is essential to note that the patients enrolled in our trials have exhausted available standard treatments, making clinical responses achieved all the more meaningful. Our achievements in the past year underscore the immune potential immense potential of Botensilimab, both as a stand-alone therapy and in combination with balstilimab and or chemotherapy. All of these trials are currently ongoing. The presentation of our data at 6 prestigious scientific forums and publication in 5P review journals is a testament to the robustness and significance of our findings. Dr. O'Day will delve into the clinical data shortly, providing more detailed insights during this call.
The resounding feedback from over 1,000 transitions we engaged with over the past year underscores the transformative impact of our work and the impact it could have on patient care. Turn to more, the Fast Track designation granted by the FDA acknowledges the urgent need for new treatments in our lead indications, which is refractory MSS CRC in nonliver metastatic patients.
As we spend on the threshold of a clinical and a critical phase in our regulatory journey, our focus is squarely on advancing activities for a potential accelerated approval filing. Our immediate efforts are directed towards ensuring that our development strategies align seamlessly with the FDA's rigorous standards. In 2024, our primary objective is to pursue a global regulatory strategy for BOT/BAL in our fast track indication. Following alignment with the FDA, we intend to initiate the submission of our biologics license application, otherwise known as a BLA for potential accelerated approval.
Subsequently, pending feedback from scientific and regulatory advice in Europe, we plan to submit to the European Medicines Agency, known as the EMA, in 2025. To achieve our regulatory objectives, we are intensifying our efforts to provide regulatory authorities with a comprehensive data package that demonstrates the safety, efficacy and clinical pharmacology in BOT/BAL in refractory MSS-CRC. Our Phase II study completed in October 2023 or I should say, completed enrollment in 2023 was meticulously designed to evaluate BOT/BAL's dosage and the contribution of its components.
Additionally, by the end of 2024, we anticipate initiating a Phase III study in the patient population of our proposed indication. Our commitment to transparency and stakeholder engagement remains unwavering as we progress towards delivering these potentially light altering treatments to patients. Looking ahead, our mission to enhance the lives of cancer patients to the power of immune system remains fast. That's been our mission from day 130 years ago. Of course, today with BOT/BAL leading the charge in our dynamic portfolio of agents.
To [indiscernible] this transformative journey, we are actively exploring strategic partnerships. Our ongoing collaborations have already yielded significant returns, exemplified, for example, by the recent $25 million milestone payment from BMS triggered by the commencement of a Phase II study with BMS-986442. This is a TIGIT bispecific antibody discovered and the early development was done by Agenus and it was licensed to BMS.
We have received a total of $250 million from this collaboration thus far. Moreover, we are progressing our efforts to monetize noncore assets and explore royalty financing and project funding opportunities with the potential to generate an additional $100 million to $200 million in the relatively near term. Furthermore, we're engaged in discussions with several prospective pharmaceutical partners, exploring [ revenues ] for core marketing and core development agreements specifically for BOT/BAL. Dr. O'Day will now provide an overview of our latest clinical findings further eliminating the groundbreaking progress we've made so far.
Thank you for your continued support and confidence in Agenus. Together, we are pioneering a new era in cancer treatment, one that offers hope and healing to patients worldwide. Dr. O'Day.
Thank you, Garo. Together with our investigators and key opinion leaders, we presented updates from BOT/BAL development program at ASCO GI Society of Gynecologic Oncology, ESMO GI, CTOS and at a corporate event hosted during the ESMO Congress in October. Throughout 2023, new clinical data was presented for nearly all of our programs and I refer you to our press release issued today that provides a comprehensive summary of our 2023 clinical development updates.
Today, I'd like to share a selection of our data updates from the last year, which highlights some of the compelling opportunities we have to transform care for patients. Starting with safety. We continue to observe a manageable safety profile. As of May 2023 data cut from our solid tumor Phase Ib study with doses of 1 milligram per kilo or 2 milligrams per kilo of both Botensilimab, in combination with balstilimab. The most common adverse events were immune-related, and the most common of these were diarrhea and colitis.
Grade 3 or greater treatment-related diarrhea colitis occurred in 14% of patients. These findings are consistent with the mechanism of action of BOT and BAL as both our immuno-oncology agents. Now turning to our CRC development program for BOT and BAL, where we have made significant progress. As of our latest update during our corporate event in October 2023, our Phase Ib expanded cohort of 70 evaluable patients had a median follow-up now of 12.3 months and RESIs confirmed overall response rate of 24%. Based on literature review, the response rate in a similar population treated with standard of care therapies ranges from 1% to 6%.
In addition, patients in our trial showed a 12-month overall survival rate of 74%. Median overall survival has not been reached. We anticipate having top line data from the Phase II trial publicly available in the second half of 2024. To align with our planned regulatory time line and allow for sufficient data maturation. At ASCO GI in January of this year, data was presented from an investigator-sponsored trial being conducted by [indiscernible] Cornell Medical Center. In which 12 patients with colorectal cancer were treated with 1 dose of BOT at 75 milligrams and 2 doses balstilimab at 240 milligram.
In a neoadjuvant therapy window of opportunity setting. Surgery was performed on average 4 weeks after the initiation of immunotherapy. All 3 of 3 MSI high colorectal patients had complete or near complete pathologic responses. And even more importantly, 6 out of 9 patients with MS stable colorectal cancer had pathologic responses of 50% or greater in -- including 2 complete pathologic responses. None of the 12 patients had tumor growth during the treatment interval and no surgeries were delayed during delayed due to immune-related toxicities.
There were only 2 instances of Grade 3 treatment-related adverse events, diarrhea and fatigue, which were reversible. These results represent an important opportunity to move into earlier non-metastatic lines of therapy and potentially change the treatment paradigm particularly for early-stage MS stable colorectal cancer. This IST is currently adding an additional 24 patients.
The expansion extends dosing of immunotherapy and the timing of surgery from 4 to 6 to 8 weeks, which is more reflective of traditional neoadjuvant therapy studies. Depending on the data, we plan to prioritize neoadjuvant development and are evaluating study designs for further pivotal studies. And lastly, in second-line pancreatic cancer, we reported data on 6 patients with the combination of botensilimab and with 2 chemotherapy agents, gemcitabine and [ Abraxane ] as a triplet therapy.
All 6 patients had progressed following the most aggressive first-line metastatic regimen of both [indiscernible] chemotherapy, and all 6 had liver metasis. 4 of the patients achieved marked and sustained tumor marker reductions. We reported 2 of the 4 patients achieving a partial response at 16 weeks with a confirmed target lesion reductions of 47% and 37% which was pending confirmation at the time the data was reported.
Two other patients showed stable disease at their first 8-week scan with tumor reductions of 20 and 13 respectively. A randomized Phase II study is currently enrolling, and we anticipate preliminary data being available in the second half of this year. These results demonstrate clear activity of botensilimab in cold tumors in both the refractory setting and in early disease, combining botensilimab with either balstilimab or chemotherapy.
And this offers hope for patients and families where current standards provide limited benefit. We remain committed to improving patient outcomes and are grateful of the support of our team, trial participants and stakeholders. Now I'll turn the call over to Christine to discuss financials.
Thank you, Steven. For the year ended December 31, 2023, we recognized revenue of $156 million and incurred a net loss of $257 million or $0.69 per share. For the fourth quarter ended December 31, 2023, we recognized revenue of $84 million and incurred a net loss of $49 million or $0.13 per share. Revenue primarily includes revenue under our collaboration agreements, including milestones achieved and revenue related to noncash royalties earned.
We ended the year with $76 million in cash, subsequent to which in January 2024, we received a $25 million milestone payment from BMS triggered by the commencement of a Phase II study with BMS-986442, the Agenus discovered TIGIT bispecific antibody. Additionally, we've progressed in monetizing nonstrategic assets and future milestones and royalties from ongoing partnerships.
These efforts are expected to yield significant cash proceeds by mid-2024. Accordingly, we anticipate being funded through 2024. In parallel, we're pursuing potential partnership discussions with 5 biopharmaceutical parties to further expand our cash resources. I'll now turn the call back to Garo.
Thank you, Steven and Christine. As we look ahead, of course, we're excited about the opportunities that both cancer patients and Agenus in 2024. Our steadfast indication remains centered on providing cancer patients with enhanced treatment options. A mission that not only benefits patients, but also enhanced shareholder value and secures the long-term prosperity of our company through continued innovation.
Innovation has been critical to our existence and our growth, and it will continue to be. This year, a paramount objective for us is to present a compelling data package to the FDA seeking their consent to initiate the filing of our biologics license application. Agenus pioneering advancements in oncology has been more than a mission for us. It's been our enduring commitment over many years. We expand our heartfelt gratitude to our shareholders, partners and the entire Agenus team for their unwavering support.
Together, we stand at the threshold of a transformative journey, one poised to make a profound impact on the lives of patients worldwide with the ultimate aim of delivering chemotherapy-free treatment options. Thank you very much for your time and attention. And now we invite any questions they you may ask. Audra?
[Operator Instructions] We'll take our first question from Emily Bodnar at H.C. Wainright.
My first one is on the neoadjuvant CRC study. You mentioned that you're extending the treatment period from 4 weeks to 6 to 8 weeks. So I was curious if you could discuss how you think the longer treatment period may impact efficacy and if there are certain metrics that you think could improve with a greater treatment period?
And also if you're following patients in that study post surgery to eventually look at their surgical outcomes. And then second question on MSS CRC. Could you just confirm that the timing of the BLA submission? And I believe you were previously saying mid-2024. So that still [indiscernible] is that looking more like second half now?
So Emily, I'll start with the last question on the timing of the BLA submission. So as we've guided investors before, the very first step for us is to meet with the FDA, which we're planning on doing mid-year and they're giving their specific guidance on our BLA submission. So we do not want to jump the gun ahead of that meeting and provide different guidance than what we will get out of that FDA meeting.
So bear with us, I think we're talking about only a few months from now, that we will be able to give you a much more specific guidance on our BLA solution.
Garo would you like me to?
Neoadjuvant very exciting neoadjuvant data, very exciting. And in fact, when I was talking to one of our long-term advisers yesterday, the first thing he mentioned in the conversation was how remarkable this new adjuvant data has been because of all the reasons you said to them and [indiscernible] further.
Thank you, Garo. Emily, yes. I mean, given that MS-stable colorectal cancer immune therapy has not previously been effective the 4-week window period was what surgeons were comfortable with allowing which was essentially no delay in the surgery. And these results are remarkable in terms of the percentage of patients with deep tumor regressions in 4 weeks.
So the extension of the study will allow now a proper 6- to 8-week treatment period. And we do anticipate that over that time, we will see further deepening of responses. So we're looking forward to that. The study is looking at surgical outcomes and obviously post surgery relapses. So this will be a comprehensive neoadjuvant study.
We'll go next to Mayank Mamtani at B. Riley Securities.
Appreciate the comprehensive update. So maybe just on the Phase II MSS-CRC data, are you able to comment on what statistically we should be focused on? And if the slight push out here is relating to you wanting to have the OS data or mature durability data, which I could see makes sense if you're thinking about Phase III design?
And maybe if you can also comment on thinking and timing for launching that Phase III, should we be aware of any planned regulatory meetings, discussions around that? And then I have a couple of follow-ups.
Yes. So as you know, we have as we said before, we've completed enrollment in October. And typically, 80% of the patients respond within 6 months of the first dose. So when we complete enrollment by the time the patients get the first dose you're talking about November. And by the time we get the 6-month readout or 80% of responses, it's sometimes on May. Now needless to say, we have already started cleaning up the data and all of the laterite process so that we can provide all of the outcomes as soon as possible.
So it will be in the next few months and our first step is to share this data with the FDA because the timing of the data generation and the FDA meeting will be very close. And then after the FDA meeting, we plan on making top line data public appropriately.
Phase III, design, timing, off launch, could comment on that [indiscernible]
Steven, would you like to take that, please?
Yes. I mean our plans with the Phase III trial is in the same line of therapy as the Phase II, and we anticipate getting that trial started by the end of the year, so it can be substantially enrolled at a potential producer date in 2025.
Got it. And then you're being a bit more precise about your biopharma strategic discussions than you've been before. Garo, could you comment on what areas are more or less alignment that could unlock the Coco deal structure that it looks like you're prioritizing and maybe how much does the neoadjuvant CRC opportunity kind of play a role? Because it obviously expands the market, but it also comes with a commitment of doing a long-term study.
I think it's very important to address your question in a way that evaluate any confidentiality. So we have, as you know, talked about partnering BOT/BAL for the last couple of years. Now of course, when we started our discussions with prospective partners, we had a fraction of the data we have today. Fraction of the data. And thanks to our enthusiastic physicians investigators. And of course, patient inquiries, we have had an explosive growth in our clinical trial enrollment.
I mean if you look at, for example, our Phase II trial enrollment, we enrolled 230 patients in less than 5 months. which is a record that has surprised many people. Now with all of that, you would expect, of course, that there's a fair amount of enthusiasm by prospective pharmaceutical companies. Amit, as we've talked about earlier, all of the fascination with treatments that result in weight reduction and radio biopharmaceuticals as well as ADCs. But when I ask a question to experts. I say do ADCs and biopharmaceutical cure cancer, the answer is often not no.
Now of course, we don't know if we're curing cancer. We don't know that. And the term curing cancer is a very dicey term because how do you demonstrate it -- how do you clinically demonstrate curing cancer? And the only thing that we know for sure is that there is a product called [indiscernible] that has cured the fact occurred a slice of melanoma patients.
But it's been mostly restricted to melanoma. In fact, that day was one of the pioneers in clinical development of [indiscernible] Now of course, one of the attributes of [indiscernible] is that it binds to CTLA-4. A very important receptor in the activation of the immune system, specifically T cells. Now we also know that our botensilimab binds to CTLA-4, but it does so many other things. So we are hopeful, hopeful that eventually, botensilimab activity will be broader than what Yervoy's activity has been in melanoma.
And so with that, of course, we're excited about what we're going to be doing with it. And that makes the question of a like-minded partner that will put in the resources to develop botensilimab and balstilimab. For the kinds of cancer patients, that deserve it, deserve it, meaning that our aim is that once we get the regulatory buy-in and we go for our first railway filing, our aim is an explosive expansion for the development of botensilimab.
Explosive expansion because, as you know, we have said across 9 different indications with varying denominators of 900 patients in total, we've seen some remarkable activity. There is no 2 ways about it, remarkable activity. And that is, of course, the basis for why the right partner that will be selected hopefully, in the next several months would be the partner, not just for us, but for the benefit of the patients to develop this product in the way it deserves to be developed.
So again, we have, I think, Christine slipped a number of active discussions. There are a number of active discussions right now that are going on. And unfortunately, on one hand, these discussions take a long time. Our longest corporate discussion that has resulted in a significant partnership has taken nearly 2 years with shortage on was a year. So I'm not suggesting that the partnership is going to be a year from now. But I just want to give you guidance that these things take time.
Very helpful, Garo. And just maybe lastly on that marketable activity just on the pancreatic and this TKI refractory lung cohort data would [indiscernible] Could you talk to what patient numbers you're expecting to have in your mid or second half update for pancreatic and maybe lung, if you can give some.
If I may ask either Steven or Todd to address this question, and if you have more specific clarification for the questions, please feel free to ask.
So yes, Mayank. In terms of pancreas, we have a randomized Phase III trial, and we expect to treat 60 patients total, 30 on each arm, and that trial is actively accruing for further proof of concept. In terms of the lung data, we have expanded the cohort, as we've said, to approximately 50 patients. This data is maturing. We're showing you the preliminary TKI data in our press release today.
You can see in that very refractory TKI population patients. We had 2 patients have responses and both of them were complete. The overall data continues to mature, and we'll have more data in the second half of the year to report.
Next, we'll go to Colleen Kusy at Baird.
Can you just comment what are some of the outstanding items do you think you need FDA feedback prior to the MSS CRC filing?
Is the question, what are the alignments with the FDA that will comp to potential BLA filing?
Yes.
Okay. So we want to -- first of all, we've made a strategic decision because we were moving, as I said earlier, we were enrolling our clinical trials rapidly, for example, Phase II trial and go very rapidly and it was a very important trial for us to go to the agency with because of the dose selection as well as the contribution of the elements. And of course, we had also a small reference arm.
Now of course, mind you, this trial is not powered statistically to show any differentiation between the arms. However, it is designed to address the project optimist questions. And so the question was for us, if we go to the agency and ask them a question in an abstract form. What is this? What is that? The answer is likely to be, well, when you have the data come back to us present it to us, and we'll give you an intelligent answer. And so in order to -- for us to be able to get to that point, we made a strategic decision gain that we would wait until all the data mature to the point where we had a compelling package to present to the FDA. So that's the reason why we are waiting until the data matures, which will begin somewhat before the middle of this year.
And as you know, procedurally requesting meetings and being granted meetings or in a discussion with a comprehensive data package takes a little time. So we are planning on asking for the meeting very soon and planning on having the meeting sometime around midyear, plus or minus a month.
Great. And then just one follow-up on the pancreatic development program. I know we'll have data from the Phase II trial midyear. What would the next steps look like in the development path towards approval there?
For the pancreatic?
Yes.
Okay. So just to recap, the data package that we will go through the FDA with for the CRC indication is approximately 150 patients in our Phase I trial and the 230 patients in our Phase II trial. Now with pancreatic, the next step for us, and I will ask Dr. Steven day to elucidate more. But the next step for us is to look at the randomized data result from the expansion cohort of the existing trial.
As you know, we observed some remarkable activity in second-line pancreatic cancer patients that were treated with full fury and then relapsed. And the standard of care for them is [indiscernible] now the standard of care, unfortunately, is not curative. And these patients relapse within a short period of time. Furthermore, the response rates for these patients according to the experience and published information is in the range of 10% to 15%. So we're talking about reference ARM being 10% to 15% with response rates being very short in duration.
Now of course, the denominator of the data that we presented is small, but the fact that all patients have seen a significant drop in their cancer counts. And all patients have seen a shrinkage in tumor, now remind you, not all of them are classified responses, but patients have seen a shrinkage in their tumor size has given us a high level of confidence that the trial should be expanded, and this is what we're doing.
So we have enrolled, I believe, around 30 patients in a randomized trial now. That data is maturing. And as the data matures and we confirm the results from the smaller denominator of the initial patients, then I think we will have a reason to go to the FDA and ask them for the requirements for a potential accelerated approval for this indication. Now we have also, as our colleagues may have said before, other indications that are potentially indications that we will go for approval.
One is, again, all of these will be subject to expansion of our trials to confirm the initial results on a smaller denominator. But the smaller denominator results are so compelling that for example, in lung cancer, in EGFR mutant patients, we will investigate. In fact, there's a subset of specific EGFR mutation that we will expand that cohort to understand and verify the profound reduction in tumor size that we have seen in our earlier trials.
So that will be similar to what J&J did for a larger patient population with thereby specific. And last report that I saw is for a patient population that is about a tenth of the size of what we may be pursuing the estimates for their product is in the billions in sales. So there are opportunities that we will pursue that are driven by small trials very specific patient populations that will yield very high response rates and typically, de facto biomarker-driven identification of these patient populations and that applies to lung cancer, certain subsets of lung cancer and that applies also in a different format for the new adjuvant.
And in this particular case, what we have seen in our neoadjuvant trial is a surgery sparing and when we talk about surgery sparing, we're talking about surgeries that would be debilitating for the patient. Removal of the rectum is a debilitating outcome, particularly in the younger patient population. Particularly. I mean, it's debilitating for all patients. But if you're in your 20s and 30s, and you have a lower colon -- lower left colon tumor that is cautious to direct them and that's going to yield radical surgery that would be horrible.
So if we can prevent that with our new adjuvant strategy, we believe that's a tremendous opportunity. So we're looking at all of these options and more, of course, and stay tuned.
That's very helpful. One really quick follow-up, if I can. Just on the neoadjuvant -- the next new adjuvant setting study, will that allow for the potential to get surgery altogether? Or will all of those patients proceed to surgery?
Well okay. So I'll let O'Day elaborate, but I know at least one patient after a complete response, refuse to have surgery. Now of course, that's a tricky situation. We got the ethical considerations. And we don't have an approved product in that indication yet. And hence, that recommendation cannot be made by a physician for ethical reasons right now. But if a patient refuses to surgery, it's [indiscernible] It's their life.
But you are seeing that kind of a potential develop. And of course, I want to stress the fact that everything has to be done properly with appropriate regulatory guidance. And everything has to be done in an ethical way so that we don't jeopardize the well-being locations.
We'll go next to Matthew Phipps at William Blair.
So just curious, when you said data in the second half from the Phase II colorectal study, do you think you'll have PFS data by that point seems like given the for progress in this patient, that could be possible.
So I will refer to our regulatory experts, but PFS in these patients relative to OS is such a short interval difference that I think OS is the gold standard, PFS is much less so. Steven, Todd, do you have any comments on that?
Yes. Steve, go ahead, and I'll talk.
Matt, yes, I mean, obviously, we'll have response rate, duration of response, PFS and preliminary survival in these patients as they mature over the course of the year from their last -- from when they were crude. So obviously, it's a composite endpoint. But to Garo's point, clearly, response and duration of response is what drives and prolonged stable disease drive the survival curve.
So our primary end points are obviously response duration response and then ultimately, the gold standard survival.
And I guess just curious, Garo, why not disclose at least some indication of the top line results, I guess, in May, given the 6 months follow-up by that point. why wait till after you meet with the FDA to at least, I guess, say whether or not or endpoint has been met or something like that?
It's strictly regulatory currency I think it would be not appropriate if we're ready to present that data to the FDA to make that public break before our FDA.
Okay. And I assume then you'll make disclosures publicly after receiving the minutes from that FDA meeting. So adding a little bit of time for that.
And next, we'll move to Kelly [indiscernible] Jefferies..
This is Sara on for Kelly. So one quick question on matter. So for the next update, given you've shown 6% of our response data in patients
Your voice is coming very faint and there's some crackling in the line, if you can speak closer to the microphone.
How about now?
Yes, better.
Okay. Got it. So just one question on the lung cancer update. Given you've shown overall response data in patients. Wondering what would be the efficacy you need to see on the next update to advance the program into the next stage of development? And if so, what would be the going forward plan for lung cancer? And also just wondering, can you remind us what other data disclosure we should expect in 2024? I believe the BMS partner TIGIT data is also expected this year as well? Just wanted to confirm.
Sure. So a couple of things here. On the lung cancer, as you know, we slowed down overall enrollment in the trial. So what we're doing right now, having dissected the data and looked at subsets of patients that have had significant responses -- when I say significant response, I'm talking about complete responses, rapid complete responses at our low dose level. That, to us, is a significant outcome.
So we're in the process of now defining how we would proceed, as I said earlier, with those subsets of biomarker identifiable patients. And so that's our next step in lung cancer, but that's going to happen very quickly. With regard to data for the balance of this year, we have data coming -- mature data coming from larger cohorts of pancreatic cancer patients in a randomized trial that would be some time maybe preliminary data will be by midyear, but more mature data by the year-end. We'll have more mature data in melanoma.
We will provide the sustainability of responses in sarcoma. And of course, you will see substantially more data in colon cancer shortly after our regulatory meetings.
Super helpful.
And there are no further questions at this time. I would like to turn the conference over to Garo Armen for closing remarks.
Thank you very much, Audra, and thank you very much for your attentiveness and sort of fantastic questions, actually. And I think we've covered a great deal here, and I just want to make sure that our stakeholders are insured of our commitment to make sure that we stay focused, first of all, because we're in a very unique environment, where resources are not as abundant as they were in the past.
And so maybe that's a good thing because it forces companies, not just us, but the industry to do things more rationally. So we intend on delivering outcomes with efficiency. We are poised to be able to potentially launch product, both from a CMC perspective, as well as from a commercial perspective, we have a terrific team in each category to do this. In addition to that, we have assembled a very, very competent medical affairs team so that we can drive our processes through education. Education of the system, patients, regulators as well as physicians that will eventually prescribe our medicines.
So we are retending to all of these very important components. We are a small, large company in that sense and an old young company in many ways. Thank you very much for your attentiveness and we will communicate with you appropriately at the next time.
And this concludes today's conference call. Thank you for your participation. You may now disconnect.