Good morning, ladies and gentlemen and welcome to the Caryopharm Therapeutics SoHo Storm Data Conference Call. At this time, all participants are in listen only mode. Later, we will conduct a question and answer As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Ian Karp, Head of Investor Relations.
Thank you all for joining us on today's conference call to discuss Karyopharm's additional results from the Phase 2b storm study. This is Ian Karp, and I'm joined today by Doctor. Michael Kaufman, our Chief Executive Officer Doctor. Sundar Jagana, Director of the multiple myeloma program and Professor of Medicine at Tisch Cancer Institute, at Mount Sinai School of Medicine And Lead Investigator of the Storm Study Doctor. Dan Vogel, Assistant Professor of Medicine, Hospital of the University of Pennsylvania, Anan Vernet, our Chief Commercial Officer Doctor.
Sharon Schackam, our Founder, President and Chief Scientific Officer Mr. Michael Falvey, our Chief Financial Officer, and finally, Doctor. Jatin Shah, our Senior Vice President for Clinical Development. Following our prepared remarks today, we will then open up the call for your questions. Yesterday evening, we issued a press release detailing the updated results of part 2 of the pivotal Phase 2b STORM study from the presentation at the Society of Hematologic Oncology, Soho, 2018 annual meeting.
The release is available on our website as are the slides at karyopharm.com. Before we begin formal comments, I'll remind you that various remarks we will make today constitute forward looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. These include statements about future expectations, clinical developments, and regulatory matters and timelines, the potential success of clinical candidates and our plans and prospects. Actual results may differ materially from those indicated by these forward looking statements as a result of such various important factors including those discussed in the Risk Factor section of our quarterly report on Form 10 Q for the quarter ending June 30, 2018, which was filed with the SEC on August 7, and any other filings we make with the SEC. Any forward looking statements represent our views as of today and should only and should not be relied upon as representing our views at any subsequent date.
We may elect to update these forward looking statements at some point, we specifically disclaim any obligations to do so, even if our views change. Therefore, you should not rely on these forward looking statements as representing our views of any date subsequent of today. With that, I'll now hand the call over to Doctor. Michael Kauffman, our Chief Executive Officer.
Thank you, Ann, and good morning, everyone. Thank you all for joining us. In April of this year, we announced positive top line results from the pivotal phase 2, of our Phase 2b STORM study evaluating oral selinexor plus low dose dexamethasone in patients with pentium refractory multiple myeloma. Yesterday afternoon at the Soho Annual Meeting, Doctor. Sundar Jagana presented updated an additional positive results from the study that continue to be encouraging and reinforce our belief in selinex's potential to provide new hope for patients and families suffering from this difficult condition.
Notably, based on independent review committee assessment, selinexor achieved 26.2% overall response rate or ORR. And a duration of response or DOR of 4.4 months in patients with penter refractory myeloma. In addition, Doctor. Jagana provided aggression free and overall survival data amongst various subsets. On the call today, we are very pleased to be joined by The 2 renowned multiple myeloma experts, including Doctor.
Jagannat, the STORM study principle investigator, who will provide an overview of the study results presented at SoHo, and Doctor. Dan Vogel, a storm study investigator who will expand upon the results in various subpopulations. Anon Varadan, our Chief Commercial Officer, will then provide an update on our commercialization efforts as we prepare to bring selinexor to the market pending the ongoing FDA review of our new drug application. As a reminder, Caryopharm completed the rolling submission of a new drug application with the FDA in August seeking accelerated approval for oral selinexor plus low dose dexMS zone for the treatment of patients with penta refractory multiple myeloma. Selinexor has already achieved both orphan drug and fast track designations from the FDA for this indication.
I would now like to turn the call over to Sundar to discuss the storm results. Sundar?
Thank you, Michael. Good morning to everyone. I'm delighted to join the team today to review the promising updated results from part 2 of the strong study. Before diving into these results, I'd like to provide a short overview of the study design. The Phase 2b storm study is a single arm, international multi center clinical trial evaluating selinexor in combination with low dose dexamethasone.
In the Journal of Clinical Oncology by my colleague, Doctor. Dan Wogo. You will hear from him. Part 1 of the study enrolled 79 patients with either cohort or penta refractory myeloma, so 2 different patient population. And investigated 2 dosing regimens.
Based on those results, the trial was modified And part 2 of the study enrolled a completely distinct and separate cohort of 122 heavily pre treated patients only with pentar refractory myeloma. These patients had previously received 2 proteasome inhibitors, Wellcade and Kyprolis, 2 immunomodulatory drugs, Revlimid and formulas, and an anti CD38 monoclonal antibody DARZALEX, as well as alternating agents. In addition, their disease must be refractory to glucocorticoids at least one PI, at least one AMID DARZALEX and to the most recent therapy. Patients started with 80 milligram of oral selinexor twice weekly in combination with low dose dexamets on those at 20 milligram twice weekly. Many of the patients entering the study had no other therapeutic options including other clinical trials, and we would have normally recommended palliative care if the study was not made available to us.
It is worth noting a few specific points regarding this TORM study population. First, there was a short washout period of only 2 weeks since last therapy, allowing patients whose disease is rapidly progressing to enter the study quickly. 2nd, patients can enroll with moderate or even severe renal dysfunction which is common in myeloma, especially in late stages, and in fact, 1 third of the patient had moderate to severe renal dysfunction on this study. And third, the criteria for neutrophil red blood cells and platelet counts were also very liberal such that heavily pretreated patients 2 recently published reports have documented that the average survival of patients with benter refractory myeloma is less than 4 months. Turning now to the study 7 prior therapeutic regimens prior to entering the trial.
Oral selinexor plus low dose dexamethasone achieved an updated 26.2% overall response rate, the storm studies primary objective. This included 2 stringent complete responses, 6 very good partial responses, and 24 partial responses. The 2 stringent complete responses are particularly meaningful as they were negative for minimal residual disease, 1 at 10 to the minus 6 and the other at 10 to the -4 sensitivity. This level of response is particularly difficult to achieve in the setting of late line refractory disease and provides further evidence of the potential potency of selinexor. 86 patients had previously received DARZALEX as a part of a combination therapy.
We would expect these patients to have a particularly poor prognosis, yet we observed an overall response rate of 29% in this population. In addition to the rate of 26.2 percent overall response or partial response or better, 13.1% of the patient achieved a minimal response for a total clinical benefit rate of 39.3%. I will note that all responses were confirmed by an independent review committee. For the secondary objective of the study, Media progression free survival or PFS was 3.7 months. The median duration of response or DOR was 4.4 months based on a range of less than 1 of 8.6 months.
The median overall survival in nearly 40% of the patient with at least a minimal response to selinexor was statistically significant at 15.6 months. While patients whose disease progressed or were not available, had a median survival of only 1.7 months. These results are statistically significantly different with the pre value of less than 0.301. Across the relevant patient population, selinexor's adverse event profile was consistent with those reported previously from part 1 of the study and from other selinexor studies. The side effects were often managed with dose adjustment and supportive care.
The most common non hematologic side effects were largely Grade 1 or 2 and included fatigue in 70% Narsia in 69% and Rxia in 51% and weight loss in 43%, all of which were anticipated. The most common grade 3 or 4 adverse events were cytopenias, thrombocytopenia, 54% and anemia at 29%. And were generally not associated with clinical sequelae. I will also note that there were no major cardiac pulmonary, hepatic or renal organ toxicities, which led to study discontinuation. These results are compelling and truly are exciting for the patients and families with penta refractory disease selinexor with its normal mechanism of action and convenient oral dosing has the potential to be an important treatment option for patients with tenter refractory myeloma within the greatest therapeutic paradigm.
With that, I'll turn the call over to Doctor. Dan Vogel, for additional analysis of the results. Dan?
I share Sendo's excitement about these results and wanted to specifically highlight the results in some of the subpopulations that we analyze, probably most notably, as Sundar already mentioned, about 70% of the patients in this study had disease that had progressed not just following treatment with DARZALEX, but specifically DARZALEX in a combination regimen before they enrolled on study and started treatment with selinexor and dexamethasone. The patients in this subgroup who had received a DARZALEX combination an overall response rate of 29.1%. And because that combination is a standard way of treating relapsed myeloma these days, that response rate is particularly meaningful. And we see that in previously published data that the DARZLIK combination regimens, including with Revlimid and Velcade in earlier settings, resulting very high overall response rates. And prognosis is really poor for patients once their disease progresses following DARZALEX therapy as they tend to have an overall survival meant in the range of 3 to 4 months, as Cinder mentioned.
So I think it's compelling that Selinexor was able to demonstrate meaningful responses and an overall survival of 8.6 months across this entire population and longer survival for patients with any kind of response. Finally, I'd also like to highlight the 2 patients from this study who had relapsed after receiving prior investigational CAR T cell therapy. And both of these patients went on to achieve a partial response to oral selinexor treatment. And while of course, that's only in patients as CAR T cell therapy is still experimental and not widely available. These results further indicate potential selinexor in patients with heavily pretreated myeloma who have exhausted even other promising investigational therapies.
I'll turn the call over back now to the carrier farm team and to Anant.
Thank you, Doctor. Willoughville, and good morning, everyone. The storm data presented yesterday and discussed earlier on this call illustrate exactly why I'm so excited to have joined the Keriopharm team. To build and lead our commercial efforts rarely do you have an opportunity to bring a completely new approach to treating patients with a life threatening illness based on a revolutionary insight into fundamental biology. My team and I are acutely aware of the critical role that we play in helping patients benefit from the amazing work that has been done at Ferrier Farm over the last decade.
Our growing commercial organization is focused on hiring the best team in building the necessary infrastructure to bring selinexor to the appropriate patients. Everything we will do is going to be done with the single-minded goal of maximizing the patient experience. Our plans include working to provide unimpeded access when selinexor is indicated and ensuring patients have the support they need to fully benefit from treatment based on all of our learnings from optimizing selinexor therapy. We're building plans to serve the needs of all key stakeholders starting with the patients themselves and their families and including myeloma experts, community based clinicians, oncology nurses, key payer segments and the supply chain. Now, of course, central to all of this is to have the right product with the right clinical data and an FDA approved label.
And market research that we've done recently with oncologists reinforces the importance of the clinical data generated from the STORM study. Our research indicates that physicians place significant importance in a completely new mechanism of action in treating patients with advanced myeloma and that oral administration is welcomed. Since there's no cure for multiple myeloma, clinicians are constantly seeking additional treatment options, The many patients who unfortunately will relapse or become refractory to therapy, nearly 13,000 deaths from myeloma are expected this year in the United States. Underscoring the urgency for new treatments. Our research indicated that physicians value the clinical data from storm based on the overall response rate including the 2 MRD negative stringent complete responses in such response of 1 cycle could allow physicians to identify patients who are responding relatively quickly.
Should the FDA grant our request for accelerated approval, selinexor could be available to patients in the first half of twenty nineteen. Additionally, in the first quarter of 2019, we plan to submit an MAA the EMA for conditional approval of selinexor in the European Union based on the data from the STORM study. The data presented yesterday is another positive step forward for these patients, and I look forward to providing future updates as we progress. I'll now turn the call back
pentrorefractory myeloma population. Our storm data are an exciting milestone for our company, but more importantly, they represent an important advance for the greater myeloma community patients, families and treating physicians participating in this study. We want to recognize their support and express our sincere gratitude for their important contributions to the STORM study in the development of selinexor. In addition, we also wish to thank the multiple myeloma research foundation for being an invaluable partner for many years, and for their extensive support and encouragement. We plan to continue to build our momentum and execute on commercial initiatives outlined by Anan order to introduce this treatment option to patients as rapidly as possible.
In parallel to our pensive refractory program, We continue to advance our development strategy aimed at moving selinexor to reach patients in earlier lines of treatment. Our pivotal randomized Phase III BOSTON study is evaluating once weekly oral cell decks in combination with once weekly Velcade compared to standard twice weekly Velcade Dex alone in patients with myeloma who have had 1 to 3 prior lines of therapy. We expect to complete enrollment in Boston this year, and report top line data at the end of 2019. Separately, our broad STOM study continues to advance the evaluation of cell decks in combination several standard approved myeloma therapies, including Revlimid, POMALIST, Velcade, Kyprolis and DARZALEX in patients with relapsed or refractory myeloma. And in combination with Revlimid in patients with newly diagnosed myeloma.
We plan to provide periodic data updates from Stump at upcoming medical meetings. Outside of myeloma, selinexor is also being developed for diffuse large B cell lymphoma or DLBCL for liposarcoma for endometrial cancer and for other malignancies. We remain on track to report top line results from the Phase 2b SADAL study. Evaluating single agent selinexor in patients with relapsed or refractory DLBCL who are not candidates for stem cell transplantation. By the end of 2018.
Pending positive results of the Sabo study, we plan to submit an NDA requesting accelerated approval of selinexor in the first half of twenty nineteen. Advancing the treatment of cancer through the discovery and development of novel oral therapies like selinexor. Our team is expeditiously working on behalf of our brave patient community, to bring these therapeutics to market as quickly as possible, and today's data are another positive step towards meeting that goal. Over to the operator
Your first question comes from Brian Abrahams from RBC Capital Markets. Your line is open.
Hi, everyone. This is Beau Miller on for Brian and we both congratulate you on the update Just a few questions. I guess first bigger picture, how have the discussions been going with the FDA, both pre NDA and your submission? And how might you characterize the frequency and nature of those interactions since you received fast track designation? And also can you help us get a sense of how the regulators might view the high median OS among responders and kind of what their thinking is there?
We don't really comment on interactions. They've been very good. Obviously, FDA granted the Fast Track application. As you mentioned, they granted the rolling submission And we're in the usual discussions. It's been a great relationship and we hope to continue it.
That's all we're really prepared to say. On the overall survival, obviously, I think everybody's extremely excited about this. This population has publications has a dire prognosis. And the fact that up to 40% of our patients who had at least a minimal response had such a significantly improved survival I think bodes well for patients. And furthermore, even patients with stable disease on our study appear to achieve some benefit as we stop the progression of this refractory myeloma.
Great. And then can you also contextualize the median PFS of point 7 months and maybe among some of the subgroups you presented. How does that compare to other agents like Dara and Palms when looking at similarly a sick population?
7 months. That's really in line with what we saw with, really carfilzumab, Palmdara. So they're all around that 3 to 4 month range. So I think similarly, but I think the key point is that those patients who do respond, with an MRPRECS and OSS. So that really drives the clinical benefits.
So when you talk about median PFS in this late line therapy, it's very much in line with what we expect to see and what we've seen with previous accelerated approvals, but the key really is that response rate drive to clinical benefit, which, can be reflected in the PFS and OS.
Okay. And then my last question, and I'll hop back in the queue. On the safety profile, could you just provide a little more color on the persistence and manageability of some of the side effects you observed like fatigue and nausea and some of the hematological AEs? And then to what extent do you feel that mirrors an increase in understanding by physicians to manage these side effects that is driving the better responses among responders? So
these are pretty heavily pretreated patients who are generally sick and they are also losing weight because their cancer is not under control and they have gone through all these different therapy. I say alluded to before, if this clinical trial was not available, we would have offered them in hospice care. So such being the case, here's an oral agent, which has the side effect of nausea, anarxia, and vomiting. So under those circumstances, if the physicians and this is an oral agent. So if you are the patient can take the pills at home, but if you reach out to them and make sure they are able to eat and drink well.
If not, just bring them and give them IV fluid hydration, the very fact that you give the hydration alleviates the subsequent nausea sensation and actually they do better rather than saying them to stay home and take more nausea medication. So Those are the key element in managing these particular patients. And then of course, the patients, advanced cancer patients are usually fatigued So keeping the motivation up and especially the moment they show a response, these patients get really motivated and then they stay on it. So monitoring them a little more closely, including with the laboratory parameters because the responses are pretty fast, but are seen within a month So we monitored the patient's response also fairly closely. So this gave a feedback loop for the patient.
So then these patients get more encouraged and they do better. And the other reason for fatigue, the patient were allowed to come in the trial because they have been heavily pre treated patients. So they all come in with anemia. They come in with thrombocytopenia. So there is an added component of fatigue from not only the disease burden and all the treatment they have, but actually they are quite unname it too.
So all of that adds to it. So supportive care place an important role and the tolerance get better.
And maybe if I may ask a
follow-up if you can also comment, that would be great.
Great. Your next question comes from Eric Joseph from JP Morgan. Your line is open.
Hey guys, thanks for taking the questions and congrats on the update. Just a couple of questions from us. I guess first for either Doctor. Draganeth or Doctor. Bogle, I guess with, with Dara combinations increasingly being early line standard of care.
I'm just wondering how we should think about patients achieving minimal response or stable disease, in that context in a post you know DARZALEX combination setting, and how you think about achieving at least stable disease, how it would sort of factor in either decision to keep a patient on selinexor moving to a potential alternative or move over to another investigator agent perhaps a clinical trial. And also another question for the company. Maybe just so you can help kind of put the survival of 8.6 months into context. How does it contrast with sort of survival expectations in the post air refractory patient population? Thanks.
So going back to your first question, yes, the data is being used more often in combination, okay? So that is true. But the point is that this particular trial that was the key component that once the patient had failed, you know, pempere refractory, all the available agents and they were literally, they did not have any real approved treatment option in that setting. In those patients, even if they had failed daratumumab combination. This drug showed the same response rate, 29% overall response rate, showing that it didn't matter which class of drug the patient had been exposed to because this is the 1st in class new drug mechanism of action And what we are all impressed is that this is a true addition to the treatment armamentarium of myeloma bringing in a new class of treatment.
And then there is already a Boston trial where they are moving it, comparing it with Wellcade dexamethasone given twice weekly versus WellCADE and selinexor given once weekly regimen. And I am very confident that will be very positive. So for me, the first of all is currently getting an accelerated approval is This drug is very critical for patients who have failed anti refractory and truly don't have an option. This drug really provides an important option and especially an oral agent And in the future, this drug could be properly primed in the right clinical setting. And for the second question on the drug you asked?
Yes. So what we know And it gets a little bit to the stable disease part is, is what we know is that the patients who progressed which was a relatively small number of patients who had progressive disease or were not evaluable for response at the beginning, survived less than 2 months overall. Even patients with stable disease appeared to derive a benefit. And that's because as Sundar mentioned, they have penta refractory disease. They're coming in with rapidly progressive myeloma.
And if the disease is not controlled immediately, these patients unfortunately will really run out of options and and be in dire straits. And the published data suggests that the responses that the overall survival of this population is between 3 4 months without additional treatment, novel treatment. And our overall entire population survival was 8.6 months. And as a, just as a preview, we have also looked into this and tried to come up with additional independent data, which we hope to present in the future suggesting that it's 3 to 4 month range for survival in the real world. This is probably accurate.
We're very excited about the entire population results.
Your next question comes from Marie Raycroft from Jefferies.
Hi, good morning and congrats on the update. First question is on the 3.5 median overall survival estimate referenced on slide 4. Wondering if you can go into more details or background from the two publications you mentioned Does that number come from multiple studies or anything else you can provide on that would be helpful.
Would you repeat it again?
The median overall survival estimate of 3.5 for PentryFractory patients, which is reference on slide 4. And I think there were 2 publications that you guys mentioned too, which I haven't reviewed those publications, but I'm just wondering if you could talk more about the data that gets you to the 3.5 number?
The first publication is from ticket and all, it's a study with a was done in Israel that including patient, they looked at patients, that what we did DALZALEX and following them after they included several population. 1 of the population that they investigated was patient that got treated with DARZALEX as a single agent, had well heavily pretreated. And they looked at this the what happened with these patients post progression on DARZALEX. Many of them moved into they added additional drugs. So they treated the patient with DARZALEX in combination.
And after that, they went through as a salvage therapy. And the, the slide that was presented yesterday by Doctor. Jaganaz in case from that paper in which it shows results these 22 patients with heavily prutruded myeloma that's treated with DARZALEX combination and then moved into established therapy.
Okay. Okay. And then the other question I had was on the 2 CAR T patients. I'm wondering if you can provide more details on those patients particularly treatments they received before or after the CAR T. And if they responded to the CAR T.
And is there any read through to your DLBCL program that we should consider?
So I'll just comment, Camessa, your last question as well regarding the post DARZALEX survival. So there's a growing body of data now in that postars lecture. And I think we'll see more and more of that coming. But I'll refer you to a paper by Doctor. Ismani as well.
Who looked at post DARZLEX outcomes as well. And I think you'll see consistently, that the overall survival is quite short in these patients. There's another paper as well. Up from the Mayo Clinic by natural lection, which is very similar as well. So I think that, there's a growing body of evidence now of this short overall survival across various single center retrospective studies.
Of this meeting overall survival, that's going to be four range. So I think that just want to make sure I highlight that piece as well. And then coming back to your question about, CAR T cell, correct? And the 2 patients that responded post CAR T cell?
Yes. So
I don't know the response to those prior CAR T cells. And so, we'll share that data at a future meeting. As we go into that. But I think the key is that, even after a CAR T cell therapy, these patients do respond your questions, does that apply from the large cell lymphoma data with CAR T cells?
Yes.
Yes. So I think that it's difficult to tell, but what clearly say that when we look at, across various subsets, so if we look in patients who had prior daratumumab, prior daratumumab in combination, if they've had prior transplant, combination chemotherapy of DT PACE or refractory any of the novel therapies across any of those subsets, we see a really preserved response rate, and even a little bit higher response rate in the post arm select patients. So regardless of the prior therapies that they got, again, going to the mechanism of action that this is does not have any cross resistance to any other prior therapies and because novel mechanism, it doesn't really matter what the patients had or did not have before. And we really have a preserved response rate. So is it novel therapies, it is chemotherapies, it's CAR T cells, these patients are all benefit from selinexor.
Got
it. Can you comment if if you have any patients who have failed CAR Ts in the Saddle study?
We're not aware of any. These are transplant in and generally not the same population.
Right, right. Okay. Okay. Thank you very much and congrats again on the update.
Your next question comes from Jonathan Chang from Leerink Partners. Your line is open.
Hello, and thanks for taking my call. This is John Bett on for Jonathan Chang. I was just wondering if you could provide some context around the patients who switched from very good partial response to partial response?
Sorry, we're not aware of any patients that did that.
Usually in clinical trial, you'd give the best response for the patient. And then later on, you will see whether the patient progressed you don't, give data of a very good partial response patient going down to partial response, then going down to stable and then progressing or something like that. So it is, I'm not aware how to answer your question.
Understood. And then in terms of the market research you guys have been doing for the preparation for commercialization. You mentioned the doctors are very interested in the clinical data surrounding ORR and the complete responses, has your market research focused on the doctor's opinions on the safety and toler tolerability of selinexor and what are some of the takeaways you've gleaned from those discussions?
Hi. This is Ananda and John. So yes, thanks for that question. Yes, of course, in our market research, we addressed also the the tolerability of the side effects that we're seeing in storm as well as the efficacy data. And their response to that was generally that then especially given the our own experience within the study was that they would deploy the necessary supportive care for these patients depending on the kind of side effects that they would face.
So whether it was the cytopenias and the supportive care that would be necessary under those circumstances, or the constitutional symptoms. They are accustomed to dealing with these kinds of side effects. And I think that the key and the key learning for us is that they have a proactive posture towards this that they're vigilant and that they deploy that support for the patients so they can continue to benefit from the therapy.
Great. Thanks. That's all I had.
Just to go back to your
I think we understand why you asked the question. I think between the abstract and then the final data, the abstract 6.5% VGPR rate included VGPR or CR. So nothing changed. The VGPR plus CR rate is 6.5%, including 4.9% VGPR and 1.6% CR.
I see. That was my apologies. That was my mistake then.
Your next question comes from Mike Ulz from Baird. Your line is open.
Hey guys, thanks for taking the question and congrats on the update well. I have a question for Doctor. Jagannath and Doctor. Vogel. Maybe you can comment on what percentage of your current patients are pentor refractory?
And is there any reason you wouldn't put them on selinexor?
Okay. That's a good question. So at Mount Sinai, I, being in Manhattan, we primarily have been rating on relapse and refractory myeloma. So we get a referral of patients who have been treated by community oncologists. And once they have failed on the option, that the patients are referred to us.
So it is kind of a skewed population rather than, say, if you are the only freestanding cancer center for a long distance. So you are only treating your own patient population. So we see a lot of patient, and that's how we ended up being one of the high enrollers on this particular trial. And the part of it was also driven by the fact that we have other clinical trials also open, including CAR T cell therapy, etcetera. Then we find that when the patients are being referred for resale or the patient refer themselves.
Many of them are in such dire strait. The disease is progressing quickly. They need treatment right away. That will be effect. There, because as you know, in CAR T, needle to infusion time as they call it, needle to needle time.
You collect the T cells, then they have to wait till the CAR T cells are prepared. Then you have to administer it. So almost a month, some of these patients cannot even wait that long. And the second thing is, which is very important for this particular clinical trial. The entry was a lot more liberal than any other clinical trial option.
The platelet count is 70,000, the hemoglobin It could be 8.5 just above that. So the creatinine, especially you were allowed CKD Stage 4 that means eGFR at $20,000,000 interim per minute or greater, we don't have that luxury in any other clinical trial. So there were many reasons why patients were able to enroll on this particular trial. And that's why I feel like if and when this oral agent gets approved, it would become very important for the myeloma community at this time.
Operator, I think we have time for just one last question.
Question comes from the line of Konstantin Aprolakis. Your line is open.
Hey guys, thanks for fitting me in and let me add my congrats on the update. So in getting some additional color from Doctor. Jaginaw from the 2 patients that achieved stringent complete responses. Could you perhaps share the disposition of these patients when they initially came on study and then the kinetics of their responses to SELI? And I got a quick follow-up.
Well, I'm only privy to one patient who happens to be my, patient who went into complete permissions, stringent complete remission, and that lady travels to Europe and comes back and we had to make provisions for all that and actually have one of the IFM physician do the CBC, etcetera, because she is still on clinical trial to get us the CBC and other information on a timely fashion we are not violating the protocol. And she is still being strong. I believe at least a year now. So we are totally thrilled that woman is thrilled because her life is back to herself and she is traveling and doing well. I do not know about the other I can answer about the other patient.
It's not mine.
So I think, this is Jake. Michelle, so I'll just comment on the second patient. So a very similar experience that Doctor. Jagias, patient who is in a long term remission doing well, tolerative therapy almost out to the year as well. So similar experience of a second patient as well with a durable CR.
So you mentioned Doctor. Jagnath, your patient is still traveling, which is pretty remarkable considering how late in treatment these patients are. Did you notice sort of a anecdotal difference in how that patient is tolerating the treatment versus the general patient population?
Yes. So this patient, once she would complete And so the other issue I always said is that the depth of response matters to the patient in many ways, because the side effects also the acenia weakness tightness also gets somewhat mitigated once they have an excellent response because physiologically these are heavily patients whose disease is progressing. So these patients, when they come to your clinic, they are sick. You literally see them. They are sick.
They are not coming in, not like a first relapse patient or a biochemical relapse. So they are physiologically good. These are sick patient who has throplocytopenic, have renal impairment, etcetera. Once they have a good response, there is improvement overall. The blood counts get better throughout the hemoglobin is better.
Their kidney function is better. So some of these other as leniency we attribute to the medication actually gets mitigated. So I think that's reason. And then you are absolute right. There are some patients, just like you know Velcade, it's you get peripheral neuropathy and can't tell who's going to get neuropathy and who's not and who's going to get a painful neuropathy and when it happens.
So likewise, in this drug, there are patients who are able to take this drug and have no nausea or any side effects at all. So there is also inter patient variability And that is something I think we need to move in forward, have to look at it a little more carefully. But the only thing I would say is This drug is out there in lymphoma, in sarcoma, in GYN cancer, etc. And so there is a large body of safety information coming along. And along with that, I think, we would also able to come up with a better dosing and scheduling and what therapeutic level very critical and all those things.
So this is a new drug. We are all sticking to the protocol driven thing because it was phase 1. Now it is phase 2. There is also a learning curve for all of us involved. So I'm pretty sure this will become an important drug in the near future.
Perfect. Thanks very much and congrats again.
I am showing no further questions at this time. I would now like to turn the conference back to Michael Kaufman.
Sure. Thanks so much and thanks to all of our participants and everyone on the team here. And in closing, I'd want to thank everybody for dialing in today and the questions, which were excellent. And we look forward to keeping you updated on our continued progress. A great day everyone.
Ladies and gentlemen, this concludes today's conference. Thank you for your participation. And have a wonderful day. You may now disconnect.