Welcome to the Cardiff Oncology Clinical and Business Update Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session.
To ask a question during the session, you will need to press star one one on your telephone, and you will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I'll now turn the conference call over to Kiki Patel of Gilmartin Group. Please go ahead.
Thank you, Operator. Joining us on the call today from Cardiff Oncology are Chief Executive Officer Mark Erlander; Chief Medical Officer, Dr. Fairooz Kabbinavar; and Chief Financial Officer, Jamie Levine. During this conference call, management will make forward-looking statements, including without limitations, statements related to guidance, results, and the timing of data readouts for onvansertib clinical trials. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties.
Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors in its annual report on Form 10-K filed with the SEC for the year ended December 31st, 2023. Cardiff Oncology undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations. With that, I turn the call over to Chief Executive Officer Mark Erlander. Mark.
Thank you, Kiki, and good morning, everyone, and welcome to the Cardiff 004 initial data release call. In the fall of 2022, we announced we had discovered an exciting finding from our phase I-B/2 trial in second-line KRAS mutated mCRC. Patients who did not previously receive bevacizumab or Bev exhibited a significantly higher response rate than expected when treated with our drug candidate, onvansertib in combination with the standard of care. This finding sparked a deep dive into preclinical translational research, where we uncovered a novel mechanism of action for PLK1 inhibition.
This effort, going from the bedside back to the lab bench, revealed that onvansertib has the greatest potential for success both clinically and commercially in first-line RAS mutated mCRC, where all patients are Bev naive. We were convinced that we should pivot to a first-line clinical development path, and in addition to our views, we had external sources of validation as well when we shared our comprehensive data package with the FDA and with Pfizer through their seat on our scientific advisory board. Both provided their support for a first-line program. In fact, Pfizer Ignite is providing the clinical execution of the trial.
Furthermore, the significance of this discovery is demonstrated by the recent acceptance of our findings for publication in ASCO's flagship journal, the Journal of Clinical Oncology, or JCO, and the United States Patent and Trademark Office has recently issued to us a patent which extends to 2043. That is a method of use with claims that cover treatment with onvansertib in first-line KRAS mutated mCRC patients. We announced our first-line program in August of 2023. Today, we can share an initial encouraging first-line clinical data set. In addition, we can also share that as a result of these new Cardiff 004 clinical data, we've completed a financing of $40 million from new mutual fund and biotechnology dedicated investors, along with support from existing investors.
You can find the data supporting our move to the first-line setting in our corporate presentation on our website. As you can see in slide four, today we will cover three critical topics for establishing the scale of the opportunity we see for Cardiff Oncology going forward. We'll start with our new clinical data from the Cardiff 004 trial. Our Chief Medical Officer, Dr. Fairooz Kabbinavar, will present the initial data from the trial, which evaluates onvansertib combined with the standard of care in the first-line treatment of RAS mutated mCRC.
Next, I'll discuss the significant market potential for onvansertib in this setting and why we believe it represents such an attractive focus for our efforts. Finally, I will conclude with some comments about the broader potential for onvansertib beyond mCRC. Today's announcement shows that our preclinical findings can identify new clinical areas where treatment can be improved with the addition of onvansertib to the standard of care regimen, and we want to share some of these other indications that our preclinical data suggests that we should explore. Before turning to the data, I'd like to remind you that our drug candidate, onvansertib, on slide five. Onvansertib is a serine/threonine kinase inhibitor targeting the enzyme polo-like kinase 1 or PLK1, a well-established oncology target.
Onvansertib is a highly specific inhibitor of only PLK1, is administered orally, and has a short half-life of 24 hours. We believe this unique pharmacological profile avoids the toxicity seen in previous PLK inhibitors. With data from over 380 patients treated in multiple trials, onvansertib has been well tolerated, paving the way for its potential use in combination with standard of care therapies. Now, our Chief Medical Officer, Dr. Fairooz Kabbinavar, will walk through the initial results from the Cardiff 004 clinical trial. Fairooz?
Thank you, Mark. Good morning. It's a pleasure to share initial data on the first-line Cardiff 004 trial with you today. On slide seven, you can see the design of the Cardiff 004 trial, our ongoing randomized phase II study evaluating onvansertib combined with current standard of care regimens, FOLFIRI plus Bev , or FOLFOX plus Bev in first-line RAS mutant mCRC patients. The trial will enroll 90 patients with first-line mCRC with unresectable disease and with a KRAS or NRAS mutation. None of the patients in the trial have had prior exposure to Bev .
Patients will be randomized to one of the six arms in the trial. The primary endpoint is objective response rate, and the secondary endpoints are duration of response and progression-free survival. Importantly, all of the reported trial data is based on a blinded independent central review of the patient's tumor scans, which I will refer to as BICR. This is the highest quality and stringent approach to evaluating patient response to treatment because it ensures there is no bias in the interpretation of the scans. The dosing schedule for the trial is the same as in our previous mCRC trials, where all patients receive an infusion of the standard of care every two weeks, and patients in the experimental arm receive onvansertib orally once daily for five days following each infusion.
A baseline measurement of the patient's tumors is established at the start of the trial, and the change in tumor size is determined by subsequent scans taken every eight weeks until the patient leaves the trial. For clarity, we refer to scans as two, four, six months rather than the number of weeks. On slide eight, we lay out the objectives of the trial. The first objective is to demonstrate the efficacy in the first-line setting when adding onvansertib to the standard of care. The second objective of the trial is to confirm the dose of onvansertib, either 20 milligrams or 30 milligrams daily, consistent with the requirements of the FDA's Project Optimus. Evaluating these two specific dose levels of onvansertib was agreed with the FDA at a Type C meeting in June 2023.
Importantly, confirming our dose will be based on a numerical evaluation of the safety and efficacy data from the dosing arms and does not require a statistically significant difference between the 20 milligram and the 30 milligram onvansertib arms. The third objective of the trial is to demonstrate the safety of onvansertib when combined with the standard of care FOLFIRI Bev or FOLFOX Bev . On slide nine, we show the breakdown of the 30 available patients for whom we are reporting initial efficacy and safety data today. As you can see at the far right, we have nine patients in the control arm, 10 patients in the 20 milligram onvansertib arms, and 11 patients in the 30 milligram onvansertib arms.
For a patient to be available, they must have had a scan of the tumor two months after starting treatment on cycle one, day one, so we can report the change in tumor size as determined by BICR during this period. The table on the right shows you the length of time on trial for all the patients. For example, the two-month column indicates the number of patients that had only a two-month scan. The four-month column indicates the number of patients that had two and four-month scans, and the six-month or greater column indicates the number of patients that have had two, four, and six-month or greater scans.
Around half the partial responses we have observed on a trial have occurred at the two-month scan and half at the four-month scan. Given that we are providing an initial look at the data from an ongoing trial, it is important to have similar duration on the trial for the patients in each arms for the arms to be comparable. Looking at the table, we believe that this 30-patient cohort is well balanced across the control 20 milligrams and 30 milligram arms with respect to patients' time on trial.
Given the clarity of this efficacy signal we are observing, we felt compelled to share this initial data from the Cardiff 004 trial with the investors. I'll make one last comment regarding enrollment. I'm pleased to say that as of today, we have enrolled approximately two-thirds of the 90 patients expected in the trial. We have also seen an increase in the monthly rate of enrollment, which is expected as a trial site becomes accustomed to screening patients for the trial. Based on our current rate of enrollment, we expect to complete enrollment on the trial in early 2025. On slide 10, you can see the first of the three waterfall plots showing each available patient's best response as of November 26.
Bars rising above the midline represent tumor growth. Bars falling below the midline represent tumor reduction. The yellow bars are for patients who have stable disease as defined by the RECIST 1.1, and the green bars are for patients who have demonstrated a partial response to treatment, meaning the tumor volume has shrunk by more than 30%. On the left-hand side, you see the best response for nine patients in the two control arms, and on the right are the 21 patients in the four experimental arms. You can see that there are three partial responses among these nine control arm patients, giving us a 33% response rate, and 12 partial responses among the 21 experimental arm patients, giving us a 57% response rate.
This is a highly encouraging start, and you can also see that some of the patients with the partial response have a dot over their bar. This indicates that the response was confirmed by the patient's next scan two months later. You can see that many of the partial responses on this plot are not confirmed, and this is because we are awaiting the follow-up confirmatory scan. There are no partial response patients to date who have failed to confirm their responses on the follow-up scan in any of the arms. On Slide 11, we take the same 30 patients and combine the arms to compare the two chemotherapy regimens.
Our preclinical model suggests onvansertib should be equally effective when paired with FOLFIRI Bev and FOLFOX Bev . Looking at the data for both chemotherapy backbones, there's approximately an absolute 25% improvement in response rates in the experimental arms compared to the control arms. If this remains the case, it would allow us to use both standard of care regimens in our registration trial and maximize the addressable market for onvansertib in the first-line setting. The third waterfall plot on slide 12 addresses our question regarding the efficacy of the 20 milligram dose versus the 30 milligram dose of onvansertib.
On the left are the nine control arm patients, and in the middle are the 10 patients who received 20 milligrams of onvansertib in combination with either FOLFIRI Bev or FOLFOX Bev , and on the right are the 11 patients in the 30 milligram onvansertib cohort. The results are striking. It is encouraging to see that 64% response rate in the 30 milligram dose is almost double the 33% response rate in the control arm, and in addition, the 30 milligram arm is demonstrating much deeper tumor responses, as you can see on the right side of the slide. Of the 15 patients in any trial arm with partial response, the five deepest tumor regressions are seen in the patients receiving the 30 milligram dose of onvansertib.
At this stage of the trial, the signal we are seeing in the 30 milligram dose is very impressive. The waterfall plots show each patient's single best response for all the scans they've had on the trial. But on slide 13, we see a spider plot showing how each patient's tumor has changed over time. Once again, we are looking at the same cohorts of patients, including the control arms, the 20 milligram onvansertib arms, other 30 milligram onvansertib arms. You can see on the right side that for the 11 patients at the 30 milligram dose, we started their two-month scan. Every subsequent scan for every patient shows a decrease in tumor size.
This trend based on dose is exciting, and consistent with this observation is the pharmacokinetic data we are capturing for all our patients on our trial. At this point, we have PK data for 21 patients receiving onvansertib, and for these patients, we are seeing almost a doubling of the onvansertib exposure in our 30 milligram dose patients versus the 20 milligram dose patients. Slide 14 shows the summary plot showing each patient's response over time. Here you will see that 26 of the 30 patients remain on trial. I'll briefly address the four patients that have left the trial as of this data cut. Two patients left the trial for surgery with curative intent once they were rendered resectable after being treated with chemo Bev and onvansertib, and two patients continued from the trial for non-onvansertib related adverse events.
All other patients continue on the trial. To conclude the discussion of the efficacy results of the trial as of this November 26 data cut, slide 15 shows a summary of the response rate data. Each blue box contains the results from one of the six arms of the trials, and you can see how we have designed this trial to allow for various combinations that can address the trial objectives I mentioned earlier. Regarding historical controls, no trial to date has ever prospectively examined objective response rates in first-line RAS-mutated mCRC patients. The data that are available suggests an approximate 38%-44% response rate for RAS-mutated mCRC patients based on post-hoc subgroup analyses.
In conclusion, we believe our 30 milligram dose is prospectively showing great promise against the control arms on our trial, and we will continue to track all patients on the trial and assess the data against our trial objectives. Slide 16 shows the demographic and baseline patient characteristics. While the patients are randomized to each trial arms, we still assess the baseline characteristics for any skewing that could impact the results. At this point, we don't see any sign that this has occurred in the study. Slide 17 shows the safety data for the trial. There do not appear to be any unmanageable or unexpected toxicities when onvansertib is combined with standard of care.
The grade three and four toxicities are also limited in number. Slide 18 shows our clinical development plan for onvansertib in mCRC as we agreed at our FDA meeting in June 2023. The details of our clinical development plan and the associated timelines are heavily impacted by the strength of the signal generated by the Cardiff 004 trial. The gating item for moving into a registration trial is to confirm the dose of onvansertib to be used in the registration trial.
The strength of the signal will allow us to optimize the powering of registration trial and the number of patients we must enroll so we can seek accelerated approval as quickly as possible. In addition, we are exploring the possibility of amending the Cardiff 004 protocol to convert the trial to a registration trial rather than initiating a new Cardiff 005 trial. To be clear, we could not include the current Cardiff 004 trial patients in the registration trial patient population, but converting Cardiff 004 into a registration trial would shorten certain trial startup and logistic activities. We look forward to updating our registration plans once we have more mature data on the Cardiff 004 trial. I will stop here and will return to Mark to talk about the commercial opportunity we have with onvansertib. Mark?
Thank you, Fairooz. As I said at the start of the call, we are very encouraged by the data that Fairooz just reviewed, including the overall signal of efficacy, the consistency of the data between the chemotherapy arms, the higher ORR and deepening responses at the 30-mg dose of onvansertib, and finally, the safety profile of onvansertib. If these trends in the data continue, we believe we can make a significant impact on the treatment of this terrible disease.
I'd now like to focus on the opportunity for the stakeholders of Cardiff Oncology. This starts with the patients, their families, and the medical community affected by metastatic colorectal cancer, as well as our investors who have supported our development efforts. On slide 20, you can see the scope of the opportunity for onvansertib.
Almost 50,000 patients are diagnosed with RAS-mutated mCRC every year in the United States, and it is the fourth most common type of cancer diagnosed and the second deadliest after lung cancer, and our goal is to bring a better therapeutic option to each of them, and the fact that onvansertib is not targeting a single oncogenic driver mutation like KRAS G12C, but appears effective across all RAS mutations, further expands the impact we can have. A second factor driving the significant opportunity for onvansertib is apparent on slide 21. The innovations in cancer therapies over the past 20 years have not been successful in the first-line RAS-mutated mCRC setting.
Standard care in the first-line and second-line setting remains chemotherapy and bev, so there is an urgent need for the development of new effective therapies. Finally, on slide 22, we turn to a critical element of onvansertib therapeutic profile, and we believe we'll accelerate its commercial adoption. From the small cell lung cancer IT, I'm sorry, over 380 patients have been dosed with onvansertib over multiple clinical trials, and the therapy has been well tolerated. I described earlier that onvansertib oral dosing, short half-life, and specificity for targeting only PLK1 contribute to its safety profile, and this profile allows it to be added to the current standard of care chemo backbones.
And this is a critical factor that we believe will facilitate its commercial adoption. We've heard from the investigators on our mCRC trials that simply adding an oral medication to current standard of care makes it easy to add to a patient's treatment regimen. Together, these three factors, the large patient population, the significant unmet need, and the ease of adoption create a significant opportunity for our company. I'll now conclude today's call with a comment on the broader opportunity for onvansertib outside of RAS-mutated mCRC. On slide 24, you can see the current development pipeline for onvansertib.
In addition to the mCRC program, we have promising clinical data from a pancreatic investigator-initiated trial, as well as promising monotherapy data from a small cell lung cancer investigator-initiated trial. We have not yet released data from a triple negative breast cancer IIT, but are working with the investigator to do so. The breadth of opportunities for onvansertib expands even further, and you can see in the scientific presentation section of our website several recent posters highlighting supportive preclinical data in hormone receptor positive breast cancer, RAS wild type mCRC, and ovarian cancer.
Later this week, we will present two new posters at the San Antonio Breast Cancer Symposium. We believe there are significant additional opportunities for adding onvansertib to standard of care regimens given its tolerability profile, and we will update investors as we develop new clinical programs to evaluate these promising preclinical findings. In conclusion, on slide 25, I'd like to emphasize that to evaluate the strength of the first-line data we have released today, it should be viewed together with the evidence of our previous second-line clinical findings and our understanding of the novel mechanism of action we discovered in our second-line program. We are very excited by all the nuances of this initial and positive look at first-line data.
The results so far are consistent with our expectations for this program, with a higher response rate and a clear trend towards deeper tumor regression for patients receiving the 30-mg dose of onvansertib. And these benefits are coming with a tolerability profile that is consistent with standard of care alone. And finally, we are pleased to announce that based on the strength of the first-line data, we raised $40 million this morning in an oversubscribed registered direct offering. This gave us the opportunity to add biotech-focused institutional investors to our shareholder base.
We believe this financing serves as further validation of our CRDF-004 data, and further details are contained in today's press release. Looking ahead, we plan to provide an update on our first-line program in the first half of 2025 to see how the promising data we are sharing today matures over time. With that, I will now open the call up for questions. Operator?
Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Our first question comes from the line of Marc Frahm with TD Cowen. Your line is now open.
Hi. Thanks for taking my questions and congrats on the response data today. Maybe just can you maybe speak to how many patients may be already on trial, but obviously haven't made it to that first scan yet? And then along that, kind of any guidance you can kind of provide on how many patients you think might be in that first half update next year?
Yeah. Yeah. Thanks, Marc, for your question. As we stated at the call here, today you're getting the data of all the patients that have had at least one post-baseline scan from our data cut. We do have approximately two-thirds of the patients enrolled in the trial of the 90 total. As far as releasing further data, our plan is to give another update, but at this point, we're just saying in the first half of 2025.
Okay. It sounds like a fair number of patients then of new patients will be in that update. And then maybe I know it wasn't ruled treatment-related or related to onvansertib, but can you just clarify on the couple of patients who discontinued? Just what was driving the decision, unfortunately, to discontinue due to AEs?
Yes. Yeah. Thank you. Yeah. There were, as we mentioned, four patients, and two of them went off for curative intent surgery because their tumors now became resectable. And then there were two patients that we mentioned which came off with adverse effects. They were one of the patients with it was neuropathy, so that's really tied to an oxaliplatin-based or FOLFOX. And the other one did have multiple strokes, and this was well-known attributed to Avastin or Bev . So that's really to date the total of patients that have gone off the trial.
Okay. Thanks. That's very helpful. And then maybe just one last one that's more forward-looking. You mentioned during the remarks the possibility of maybe trying to alter this trial to form the pivotal trial and kind of satisfy that requirement rather than a new one. Is this data that you have today enough to go start having that conversation with the FDA? How much more, if not, how much more do you think you need, and when might that discussion happen to kind of figure out what that next step is?
Yeah. Thank you, Marc. Yeah. We're in a very exciting part of this. As you know, we are in the Cardiff 004. One of the primary objectives of this trial is to confirm a dose to go to the registrational trial. And that's really the gating that is the data for that to support that. We will go to the FDA as soon as possible to be able to make that argument. We hope that that does not require the entire 90 patients. We're really looking to see if we can go with a much less number of patients given the clarity of the signal that we're seeing already today with 30 patients.
We're very aggressive on this and very excited and positive about it. And so I think the other decision really to do a Part 2 on the Cardiff 004 to move it into, with an amendment to the registrational, as Fairooz mentioned earlier on the call. We are obviously not using the patients in Cardiff 004 for that. However, it really does allow us to save significant time from a logistical point of view to move that registrational trial even faster than what we had originally planned.
Okay. Thank you. And congrats again on the data.
Thank you, Marc.
Our next question comes from the line of Joe Catanzaro with Piper Sandler. Your line is now open.
Hey, everybody. Thanks for the update. And yeah, let me add my congrats on the great early data here. So response rate delta looks really, really encouraging. Obviously, it seems a little too early to start getting a sense of PFS. But I'm guessing my question is, if you go historically and look at first-line experience with chemo, Bev , and other regimens, what is your sense of this response rate delta potentially translating to PFS and maybe even OS benefits? Thanks. And I'll have a follow-up.
Oh, okay. Well, thanks, Joe. Yes. Well, at this point in time, as you know, a couple of things. Number one, in previous trials, current standard of care, the chemo plus Bev , the median PFS is a range between nine to 10 months in first-line. Now, I'll just say that, as you know, in our second-line trial, our median PFS was 15 months.
So we've already demonstrated in a second-line setting a much longer PFS than what has been observed in previous trials in first-line. So we remain very bullish about this. But like you said, this will take some time for that to mature to see how that plays out. But given our past history in second-line, we remain very bullish about PFS rates in this trial.
Okay. Thanks. And my follow-up, I guess, is on safety. I'm wondering if you could just speak a little bit to whether you're seeing any dose reductions at the 30-mg dose, to what extent, if any, and whether you're seeing any growth factor support utilization in that arm. Thanks.
Oh, thanks, Joe. Yeah. We have had a couple of patients with dose reductions in the 30-mg. There have been no growth factor usage at this point. I have to say also that we've had dose reductions in the control arm as well. So I think this is kind of normal what happens. So there's nothing there to have any kind of safety flag.
Okay. Got it. Great to hear. Thanks again for the update. Thanks for taking my questions.
Thank you, Joe. Appreciate it.
Our next question comes from the line of Andy Hsieh with William Blair. Your line is now open.
Oh, great. Congratulations on the data. It's been a long time coming. So really happy for you and the entire Cardiff team. I have three questions, if you don't mind. So one is about kind of the spider plot. If you look at the 30-milligram arm, it seems like all the slope based on the last scan is negative.
So I'm just curious if you can comment on the deepening of response over time, especially for those who are so borderline relative to the cutoff for partial response. And second question, this is probably for Fairooz. Looking at the baseline patient characteristics, a lot of patients have baseline liver metastases, the 30 milligrams over 90% versus 70%.
I'm just curious if that's kind of a normal within the context of a first-line CRC patient population or you're enrolling potentially a more difficult-to-treat population. And then lastly, the third question has to do with the surgical resection. We also saw that with the phase I-B study. How common is that for patients in the metastatic setting to be improved to resectable, and how could you comment on the patients that receive drugs?
Okay. Well, thank you. Thank you, Joe. I really appreciate it. I mean, I'm sorry, Andy. I'm sorry about that, Andy. Thank you for your questions. And yes, I mean, I'm glad that you noticed that with the spider plots. We're very excited about that because, in particular, in the 30-mg, as you mentioned, there are really the slope, it's going down for all patients. And I think that one thing that we did mention, Andy, about this on the call, Fairooz mentioned it, was that we've gotten some preliminary data, PK data. And when you look at the PK data of the 30-mg versus 20-mg patients, and you look at things such as the AUC, the area under the curve or onvansertib, we're seeing about a doubling, a 2x of the 30-mg versus the 20-mg.
And so this really is exciting because we are seeing that, of course, also tracks very nicely with the increase in response rate and more deep responses that we're observing so far in this trial. And your second question, Andy, was really about the baseline liver metastases. Fairooz, do you want to maybe make a comment about that? And then also maybe come back, maybe also comment about how common is it to have surgery for curative intent.
Thank you, Mark. And thank you, Andy, for the questions. Your second question was regarding the baseline liver metastases. As you all know, colon cancer for the first stop for metastatic site usually happens to be in the liver and lymph nodes in the belly. Those are the two places.
And beyond that, lung mets and other things are uncommonly seen, not rarely, but uncommonly seen. Liver mets are very common in colorectal cancer patients. We are seeing responses at 20 and 30 milligrams in patients with liver metastases. That doesn't appear to be, at least based on our phase I-B/2 study, a feature that would predict against efficacy of onvansertib in patients who had liver metastatic disease. Patients with liver mets as well as no liver mets both responded.
Multiple mets, single mets, they also responded. So having patients with liver metastasis is fairly common for patients with colorectal cancer. Now, that brings us to the second, the last question that you had about surgery. Surgery in patients with metastatic disease over the last few years has now become a part of how we manage these patients. Initially, the patients were all unresectable.
That was one of the criteria for patients to be entered on the study. That means surgery was not an option. Subsequently, these patients, the majority of the disease metastatic foci resolved in response to chemotherapy on onvansertib. And they were left with minimal residual disease or making them potentially resectable. And resecting these patients to give them a chance at a cure is one of the parts of the continuum of care for patients with metastatic colorectal cancer. So about 25%-30% of patients, if you look again, if you look through real-world incidence, they will undergo eventually rendered oligometastatic and will be taken to curative surgery or surgery with curative intent.
Okay. Thank you, Andy. I assume there's any follow-up or we'll move on?
That's good. That's good. Thank you so much.
Thank you, Andy.
Our next question comes from the line of Robert Burns with the H.C. Wainwright. Your line is now open.
Hi guys. Congrats on the data. And thank you for taking my questions. Just one for me, if I may. So could you provide some clarity as to the data update that we're going to get in the first half and whether we can expect initial PFS data?
Hey, thank you, Robert, for your question. At this point, as you know, as I was mentioning a little earlier, the PFS for standard of care is 9-10 months, and we've already seen 15 months for PFS in second-line, so I think we'll have to watch how the data matures as far as how much of an update will be PFS in this next update.
One more, if I may, so given the strength of the data that we've seen at the 30-milligram dose, what sort of sample size would you want to see, assuming that it's maintained that delta before you move on to creating a more accelerated trial?
Right. I mean, I think we're still evaluating that as we go. But all I can say at this point is that, Robert, is that we're going to move aggressively to the FDA because that really, to your point, that's the gating factor is really getting the thumbs up from the FDA of the dose, which, as we say to her today, we would be proposing the 30-mg dose.
Awesome. Thanks for taking my questions. And congrats again.
Thank you, Robert. Appreciate it.
Thank you. And I'm currently showing no further questions at this time. I'd like to hand the call back over to Mark Erlander for closing remarks.
Well, thank you, operator. And this concludes our conference call. Thank you all again, everyone, for joining us this morning. Thank you all.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.