Good morning. My name is Gigi and I will be your conference operator today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics Phase III BOSON Study top line results conference call. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request.
I would now like to turn the call over to Mr. Ian Karp, Carrier Farms' Vice President, Investor And Public Relations.
Thank you, Gigi, and thank you all for joining us on today's conference call to discuss the positive top line results from the phase 3 in Boston study. This is Ian Karp, and I'm joined today by Doctor. Michael Kaufman, Chief Executive Officer Mr. Chris Romiano, Chief Business Officer And General Counsel Mr. Mike Mason, Chief Financial Officer and Mr.
Perry Monaco, Senior Vice President of Sales. On the call today, Doctor. Kaufman will provide a brief overview of the current treatment paradigm for patients with multiple myeloma and highlight the rationale and design for the randomized Phase III BOSTON study. He will then discuss the positive top line results from the study and the potential implications these may have on a future myeloma treatment landscape. We will conclude with a Q and A portion of the call.
Earlier this morning, we issued a press release detailing the positive top line results from the BOSTON study. This release, as well as an accompanying slide presentation, are available on our website at caratapharm.com. Before we begin our formal comments and for those following along on the slide presentation, please turn to Slide 3 and 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 our future expectations, clinical developments and regulatory matters in timeline, the potential success of our products and product candidates including our expectations relating to by these forward looking statements as a result of various important factors, including those discussed in the Risk Factor section of our most recent annual report on Form 10 K which is on file with the SEC and in other filings that we may make with the SEC in the future. Any forward looking statements represent our views as of today only.
We may elect to update these forward looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward looking statements as representing our views as of any date subsequent to today. In addition, please note that any references we make to clinical trial data during today's discussion, refer to interim unaudited site data unless otherwise specified. I'll now turn the call over to Doctor. Michael Kaufman, Chief Executive Officer.
Thank you, Ann, and good morning, everyone. I am thrilled to be here today with you to discuss the highly significant top line results from the randomized Phase III BOSTON study. This is now the 1st randomized Phase III study to demonstrate clinically significant activity of once weekly exposure in combination with the current standard of care anti myeloma treatment in patients who have previously received 1 to 3 prior therapies We are tremendously excited about these top line results and believe they could lead to a significant advancement in the treatment of patients with relapsed or refractory multiple myeloma. With increased convenience. While Xpovio in combination with dexamethasone received accelerated approval from the FDA in July last year for patients with heavily pretreated myeloma.
The top line data from the BOSTON study demonstrate the benefit exposure may offer to patients earlier in their disease progression and in combination with one of the most commonly used anti myeloma drugs available, Delcate. This, of course, will be subject to obtaining future regulatory approvals based on these and other clinical data. Most importantly, These positive data represent the next critical step in Karyopharm's unwavering mission to help improve the lives of patients with cancer and other serious diseases. For those following along in the slide presentation, please now turn to Slide 4. Unfortunately, Despite all of the progress that's been made over the past 5 to 10 years, multiple myeloma remains an incurable disease where patients and physicians are in need of new therapeutic options.
Myeloma is the 2nd most common form of blood cancer with approximately 32,000 new patients diagnosed each year and nearly 130,000 U. S. Patients living with and battling the disease. And despite a number of highly active drugs available to patients, approximately 13,000 people will die from this disease each year in the USA alone. Moving to Slide 5, I will briefly highlight the current treatment paradigm, which can be quite complex as physicians seek to tail end their treatment decisions to best meet the needs of individual patients.
There are currently 4 main classes of drugs commonly used treat patients with multiple myeloma, which include proteasome inhibitors, immunomodulatory agents, monoclonal antibodies, and now a nuclear export inhibitor. Where of course, Xpovio is the only drug in the class currently available. Phases typically receive 1 or 2 of these highly active agents in combination with a steroid such as dexamethasone in each line of therapy, and they are usually treated until their disease progresses. Physicians will then typically prescribe another combination including steroids in each of the subsequent lines of therapy. Our experience is that patients generally prefer drugs that have proven single agent clinical activity with or without steroids even when used in combination.
In addition, those patients who are eligible may decide to receive a highly combination regimen, so called induction therapy, followed by a high dose of Melfa land and rescue of their hematopoietic system with stem cell transplantation. Although the various drug combinations in this autologous stem cell transplantation are quite active, none of these approaches are curative and nearly all patients will require multiple sub lines of therapy during their treatment course. 1 of the most commonly used drugs in both the first and subsequent lines of therapy is Velcade. Sometimes referred to by generic name or tazemet. This is a proteasome inhibitor administered subcutaneously in the doctor's office and often combined with either an immunomizulatory drug or a monoclonal antibody, in addition to low dose dexamethasone.
Standard VELCADE therapy is dosed twice weekly, and as I said, must be given in the physician's office. Unfortunately, prolonged usage is often limited which was main side effect peripheral neuropathy and most patients will eventually develop either intolerable side effects or their disease will become resistant or refractory to Velcade. In order to reduce the development of refractory disease, Velcade is often combined with other agents such as Revlimid or POMALISSE, and in order to reduce the risk of peripheral neuropathy, VELK may be administered only once per week, but this lower dose has reduced anti myeloma activity. Revlimid is the most commonly prescribed anti myeloma drug. And patients typically receive it in combination with dexamethasone and at least one other agent as their first line therapy.
Increasingly, patients with newly diagnosed myeloma are receiving relevant in combination with DARZALEX, which has robust activity and low rates of peripheral neuropathy. However, despite available treatments, essentially all patients develop refractory disease require additional combination therapies with mechanisms of action not utilized on their current therapy. In particular, agents with a novel mechanism of action are badly needed as the number of patients with myeloma is markedly increased. Please now move to Slide 6. The Boston study was designed in 2016 to 2017 in order to address the growing need for combinations of novel agents following frontline regimens with or without autologous stem cell transplantation.
As Revlimid is ubiquitously used in the frontline, increasingly in combination with DARZALEX. 2nd line regimens based on Velcade or other proteasome inhibitors are becoming more important. Boston is the first study to evaluate a novel myeloma drug in combination with VELCADE for at least for patients with at least one prior therapy. Period Farm began enrollment in the BOSTON study in June 2017 to evaluate treatment with weekly selinex are now known as Xphobia, velcade and dexamethasone compared to standard twice weekly Velcade and dexamethasone or VG in patients with multiple myeloma after 1 to 3 prior therapies. Our confidence and rationale for initiating this large randomized study was primarily driven by the following factors: first, we had established strong preclinical evidence of synergies when combining Xplovio and a proteasome inhibitor.
Next, based on our phase 1two Stomp study, we had seen encouraging efficacy data from 42 patients who were treated with the SPD regimen. And finally, we knew that the current standard indicated dose of twice weekly Velcade indeximethasone was frequently reduced to once per week in real world clinical practice due to the high incidence of peripheral neuropathy and added once weekly office visit convenience, even though all Phase III trials with Velcade and relapsed myeloma have been conducted with utilizing the standard twice weekly dosing schedule, both in the experimental arm and in the control arm. And unfortunately, there is not a lot of published clinical data demonstrating what efficacy physicians can expect for their patients For all of these reasons, we decided to conduct the BOSTON study as a confirmatory Phase III trial to support the accelerated approval of Xpovio. And based on this morning's announcement for top line data, we're thrilled with the outcome. Please now turn to Slide 7, where I'll review the design of the BOSTON study.
This study is a randomized phase 3 active comparator controlled open label multicenter study designed to compared the efficacy, safety and certain health related quality of life parameters of SVD versus VD in adult patients with relapsed or refractory multiple myeloma, who have received 1 to 3 prior lines of therapy. As mentioned previously, patients on the SPD arm receive Velcade once per week while those in the BDR received Velcade at the standard twice weekly schedule. Importantly, these differences these dosing differences result in patients in the SPDR receiving approximately 40% less bulk aid and 25% less dexamethasone than those in the VDR and having about only 102 patients and the primary endpoint of the study is progression free survival. Key secondary endpoints include overall response rate, overall survival and rates of peripheral neuropathy amongst others. Additionally, the BOSTA study allows for patients on the BD control arm to cross over to the SPDR following objective progression of their disease.
The BOSTON study was conducted at over 150 clinical sites internationally. Please now turn to Slide primary endpoint of a statistically significant increase in progression free survival or PFS. More specifically, There was a 47% increase in median PFS on the SVD arm as compared to the VD arm, representing a 4.47 month improvement in median PFS. The median PFS in the SPD arm was 13.93 months compared to 9.46 months in the VDR. The overall hazard ratio These data are highly positive, especially when considering the patients in the SVDR received Velcade only once per week and left dexamethasone in addition to once weekly oral exposure.
Furthermore, we believe these top line data represent a very meaningful improvement in PFS in the treatment of patients with relapsed or refractory disease. Importantly, there were no new safety signals seen in the SBDR relative to that previously reported adverse events from other selinexor multiple myeloma trials. Additionally, there was no imbalance of patient deaths across both treatment arms and in fact, there were fewer deaths numerically in the SPD arm. As expected with the use of a triplet combination, the incidence of adverse events was higher amongst patients receiving BD than those receiving BD overall. We plan to further analyze the clinical data from this study and then submit them for formal presentation of future medical needs.
Finally, while there are, of course, many limitations when trying to compare clinical data from across different studies, it's important to understand what additional data are available from other trials that have used BD as a comparator arm. 1, most recent relevant study may be the optimism trial, which was a Phase III study that evaluated BELK plus dexMS zone, with or without POMALISSE. In this trial, the BD arm demonstrated a 7.1 month median PFS, while the BD plus POMELIS ARM at a PFS of 11.2 months and a hazard ratio of 0.61. So while we can directly compare these data to Boston, I think it does help to provide some context as to what was seen in the other recent trial using VDS comparator arm. As Meej mentioned previously, peripheral neuropathy is amongst the most common causes of treatment limitation and discontinuation of BD in combination and combination BD regimens.
I'm pleased to report that in the BOSTON study, the rate of peripheral neuropathy on the SVDR was significantly lower than the rate in the BD control arm, and we will report the full details on this data point at an upcoming medical meeting. Importantly, we have seen particularly high rates of peripheral neuropathy in other Phase III trials that have studied BD as a control arm. Often, and in most cases, triplet VD regimens have an even higher rate of peripheral neuropathy than the VD control arm. As seen in study will be a very important feature of the SVD regimen pending future regulatory approvals.
To
help put into perspective, the potential size of the opportunity Expevio may have in the future. I'll highlight the number of myeloma patients currently being treated in the United States by line of therapy. There are approximately 20,000 patients treated in the second line and 12,003 line. Which is dramatically larger than the 6000 patients in the 4th line and later, where Expevia was currently being used based on its current FDA approved indication. Turning to Slide 11.
You can see that the worldwide annual sales are the 5 most frequently prescribed myeloma drugs. All of these drugs, which have demonstrated standalone anti myeloma activity, with or without steroids, and are approved as first or second line treatment, have achieved annual sales of $1,000,000,000 or greater. While Revlimid leaves the group with $11,000,000,000 in sales in 2019, based on its broad utilization in the first line and maintenance settings as well as in lymphoma. Each of the other 4 drugs are selling between $1,000,000,000 $3,000,000,000 annually. Please now turn to Slide 12.
The graph on this slide shows some additional detail about the most commonly prescribed anti myeloma drug. Specifically, it shows the percentage of patients treated by line of therapy based on market research carrier front conducted with 120 U. S.-based physician in October of 2019. What you can clearly see is that beyond the first line setting, there is no dominant or standard regimen used in the 2nd, 3rd or 4th line or later The most prominent myeloma drugs are used to range from about 5% to 45% of patients in each line of treatment, often in a variety of combinations, depending on their label indications, individual patient needs and based on which drugs patients have already received in prior lines of treatment. It's our belief that this dynamic will continue well into the future, even with the addition of new antimaloma therapies.
Based on the Boston clinical data and Xpovio's once weekly oral delivery, we believe Xpovio pending potential future regulatory approvals will be a welcomed option for patients in the second and third line settings. Importantly, you can also see on this chart the impact exposure is already happening in the 4th line and later settings. Where Xpobio's patient share is estimated at 18%. We believe this is a testament to the receptivity by physicians for a new treatment option with meaningful efficacy data and a novel mechanism of action. Please turn now to Slide 13.
One dynamic that we believe could help create additional opportunity for Expevio pertains to the growing use of DARZALEX in the first line setting. While DARZALEX and anti CD38 monoclonal antibody was first approved by the FDA in 2015 for patients who had received at least 3 prior lines of therapy. It was subsequently approved in the 1 to 3 prior regimen setting and has recently been approved for using combination with other myeloma drugs in the first line setting for both transplant ineligible and transplant eligible patients. In fact, our own market research, which I just shared a few moments ago, indicated that DARZALEX patient share is already up to 10% in the first line setting and is most commonly prescribed in combination with Revlimid We expect the earlier usage of DARZALEX in combination with the Revlimid will continue to increase in the future, especially in patients ineligible for transplant which represents the majority of patients across the United States. If this trend continues, we believe this would create an even stronger rationale to treat patients with Velcade plus Bovio and dexamethasone.
In the second line setting, if approved, as these are different mechanism of action drugs. Even for those patients who are receiving a stem cell transplant shown on the right side of this slide, we believe there could also be a strong rationale to use Xpobio in the second line if approved as well. While many of these patients are receiving Velcade Plus Revlimid in the first line as part of their induction regimen, with or without DARZALEX. Prior to high dose chemotherapy, they are typically only receiving Velcade for 4 to 6 cycles. Following the autologous transplant, Most patients will go on to receive maintenance therapy with Revlimid for 1 to 2 years before relapse.
Thus, given the use of these drugs in the first line, We think there could be a strong rationale to treat these patients with EXPOIO plus VELCADE or another proteasome inhibitor in the second line, if approved, once their disease progresses. Turning now to based on the encouraging earlier data we saw from the STOMP Phase 1btwo trial, evaluating EXFOVIO and low dose dexamethasone in combination with 1 of several approved myeloma therapies in patients with relapsed or refractory myeloma. We continue to be strongly encouraged by the data from the additional arms of Stump study, which indicated additive or synergistic activity with Xpovio, especially when you view the data in the context of historical benchmarks. For example, in the Expobio plus Kyprolis plus dexamethasone or SKD arm of the trial, we have seen an overall response rate of 71% which compares to an ORR of 23 percent in a benchmark study, stexamethasone or SPD arm, we have seen a 56% ORR and a 12.2 month median PFS which compares quite favorably to an ORR of 29 percent and a PFS of 3.6 months in a benchmark pomalyst plus dexamethasone alone Phase III trial. Well, of course, there are many limitations when trying to compare data across different clinical trials.
The stop data shown here clearly provides strong rationale for further clinical investigation of selinexor in combination with standard approved therapies beyond just Velcade. Please turn to Slide 15, our final slide where I will highlight our key next steps following today's exciting announcement. In the very near term, we will submit the full data from the Boston trial for presentation of future medical meetings so that we can share the complete details of the myeloma community. However, our top priority remains patient focused and we plan to submit the BOSTON data as part of a supplemental new drug application requesting approval for Xplio in combination with Velcade and dexamethasone as second line treatment for adult patients with multiple myeloma. We are hoping to have this sNDA submitted during the second quarter of 2020.
Finally, depending on the FDA review time and outcome of our expected sNDA, we could potentially commercially launch Expevio in the 2nd line treatment setting in the U. S. Before the end of this year. This will be a truly remarkable achievement for Karyopharm, and more importantly, an important new option for the multiple myeloma patient community. With that said, let me take this opportunity before the Q their families, their physicians, caregivers, advocacy organizations, and carry a farm employees and investors in our company.
Who have helped us get to this monumental day. There is no way we could have gotten here without all of your dedication and persistence. And for that, we are immensely thankful. I'd like to turn the call
Our first question comes from the line of Eric Joseph from JPM. Your line is now open.
Hey, good morning guys and congrats on successful Phase III outcome here. It's really great. Just a couple of questions from me. On the tolerability side here in Boston, I'm wondering whether you could have any qualitative comments around the rate of discontinuation of dose reductions compared to what was observed in storm or the commercial experience today? And on the point of peripheral neuropathy where you're describing significantly lower rates compared to the twice weekly regimen with Velcade.
Anything that you can comment on the weight of in the way of high grade neuropathy that was observed? And as you've previously talked about the potential of incorporating peripheral neuropathy benefit in the label, how are you currently thinking about the likelihood of that benefit being integrated and what sort of what shape might it take? Thanks for taking the questions.
Yes, Eric, hi, thanks so much for your question to see you in Carf. I think as a general backdrop, unfortunately, because we just announced the top line data today and we'll be, hopefully presenting this data at future medical meetings. There's not a lot of additional color or detail that we can provide in terms of the data itself beyond what we've, we've publicly announced this morning. Don't know, Michael, is there anything that the color that you potentially could give or
really do
we need to wait for the data to take?
I think we should we need to wait. I think it's worth just noting historically with selinexor presentations, the discontinuation rate and the side effects are generally dosed and scheduled dependent. So just consider that the approved dose is 80 milligrams twice a week, which is much higher than the currently used dose in Boston of 100 milligrams once a week. And also the patient population is much healthier in the BOSTON study, just given that they have 1 to 3 prior therapies versus 7 prior therapies on the storm. The other point on peripheral neuropathy is, is that I just state, and you'll use on clinicaltrials dotgov that peripheral neuropathy was a pre specified secondary endpoint, which was concluded in the statistical analysis plan.
So we do believe this is an important endpoint and we will work to ensure that the results of this analysis are included in as many places as we can. Thank you.
The line of Maury Raycroft from Jefferies. Your line is now open.
Hi, everyone. Good morning and congrats on the update today. I was also wondering on some specifics, but I'm not sure how much you can comment on it. So for the overall response rate, if you can disclose what that is, or maybe if you can comment on the complete response in VGR rate in the SVD arm and how that could have contributed to the PFS curve separation and hazard ratio? And then if you're seeing anything on OS trend at this point?
Yes, Maureen, again, all great questions. And I think in due time, all that will be made clear. Again, at this point, as we're as we need to preserve certain, obviously, data beyond what's in the press release for future medical meetings, we just can't provide any more details beyond what was in the press release today. I don't know, Michael, if there's anything else, but all great questions.
Okay. And then maybe one more follow-up. I guess based on the market research that you did, did you test a profile similar to what you're observing with the Phase III results? Do you have a sense of what proportion of patients could end up, you could end up treating with Xpovio on the second line and third line?
I don't know if Perry, I know Perry's on the line. Maybe I'll start. I mean, so yeah, we certainly do market research to test various, various efficacy parameters. And certainly in our market research, the profile, the profile that we see from the Boston study, certainly, we believe would be well received by physicians and patients.
Beyond that, I don't know, Perry,
if there's anything else that insights that we clean from the wider research that you could share?
Not necessarily. I think, this puts Bovio in the game. And that's what the important thing is. And I think the other important thing is it expands the patient population significantly And when we do have approval, you're going to have patients that are in various points along their journey. And this puts exposure in the game at any point within the relapsed refractory multiple myeloma setting?
Got it. Thanks very much. Congrats again and I'll hop back in
the queue.
Thank you. Our next question comes from the line of Brian Abraham from RBC Capital Markets. Your line is now open.
Hi there. Thank you very much for taking my questions. My congratulations on the data as well. I recall when we had spoken years ago when Boston was being started, I think you guys had pegged the potential response the potential PFS at 13 to 14 months for the Celli arm and 9 to 10 months for the control arm. So kudos to the team.
On the trial design. A few quick questions from me. I guess first off on overall survival, it sounds like the mortality data directionally favored, Sally. I'm just wondering, should we be expecting a more significant separation over time as the data mature? And is there any sort of requirement there with respect to label expansion?
Or should we assume that's going to be unlikely just given the crossover design? I had a couple of quick follow ups.
Yes, thanks. Thanks, Brian. I think you hit the nail on the head. First of all, these are just numerical. These are numerical results.
We haven't presented any details. It would be highly unlikely or in this day and age with so many options in myeloma for any study, whether it had crossover or not to show a mortality benefit certainly not early on, but even an extended mortality benefit given the new drugs that are coming would be tough to prove. Because of that. Now this is compounded, as you said, correctly, by the crossover design, where patients on the VDR, once they hit confirmed objective progression, they are permitted to cross over. So that even compounds it further.
There was agreement from all from the FDA and the EMA on the design of this trial that the overall survival would not be a would not be expected to be superior because of the crossover. But to make sure that it was not going to be negative or inferior, and we feel very comfortable at this point that there is no imbalance at all, as mentioned.
That's really helpful context. And then I know just given the nature of the trial design, there was a process by which The progression events were reviewed by a data monitoring committee and an IRC. The FDA was informed as well. Can you maybe remind us if there had been any if there's been any opportunity for initial feedback from the agency during this process over the last several weeks and what that might look like?
Yes, the way the protocol is designed, which is specified there and then followed up by the statistical analysis plan is that all potential progression events are submitted to an independent review committee, which consists of 4 myeloma experts who are not participating in the trial. So all of the events are adjudicated by those before they are considered confirmed events. Once the number of required events was hit, for this analysis, we then submitted the data. Actually, we didn't. They went to a third party statistical review firm to so that we were not aware of the results.
And that was compiled by that 3rd party firm. And then it was sent on, again, confidentially to the Data Safety Monitoring Committee, which consists of 3 myeloma doctors and a statistician, all different from the Independent Review Committee And they basically have the protocol defined as fiscal analysis plan defined right, to, discuss the data and decide on the future of the study. And that is their purview. FDA respect these, the FDA obviously weighed in on the protocol and SAP. And, we just As part of our post marketing requirements for the accelerated approval, we did notify the FDA first, confidentially through the 3rd party And then subsequently, when we were unblinded that, this was our process and they have accepted our process and they've allowed us to move forward.
So they're not an active participant per se, but they had to be notified as part of the post marketing requirement.
That's really helpful. One last quick one for me. Any views on the potential pricing of the agent and how that might evolve as it expands into earlier line settings? Thanks.
Yes. I think at this point, it's been premature to think about pricing right now. Certainly, it's something that we're always taking into consideration. We obviously want our drugs to have as broad access to the patients that need them. So, I think at this point, it's still a bit premature to comment on any any potential changes or not that it would be in pricing strategies.
Understood. Fair enough. Thanks so much. Congrats again.
Thank you. Our next question comes from the line of Jonathan Chang from SVB Leerink.
Good morning. Thanks for taking my questions and congrats on the results. First question from a company strategy per perspective, now that Boston is positive, in terms of plans you had that were pending the Boston come, how are you thinking about next steps as a company and in terms of prioritizing additional expovio development opportunities?
Well, we'll invite you all to a long seminar on that. Great question. I think as you allude to, Jonathan, there's a lot we can do with this drug and there's a lot that we are doing with it. As you know, we have a pending sNDA in front of the FDA for relapsedrefractory diffuse large presale lymphoma. We have upcoming Phase III data in our randomized study in de differentiated liposarcoma.
We have an ongoing study in the 1st line maintenance setting. This is a phase 3 study, 1st line maintenance in patients with uterine cancer who have received platinum taxol induction therapy and then are in a response. And then we have a maintenance regimen versus Placebo, that SIENDO study is ongoing with data expected next year. So there's a lot going on already. At our JPMorgan Conference recently, we outlined some of the key next studies that we'll be doing.
Some of those are featured prominently. And those would be the randomized study in diffuse large B cell lymphoma with, EXPOVIO in combination with chemotherapy versus the chemotherapy alone. In 2nd line DLBCL, we have additional studies now initiating in solid tumors in lung cancer with docetaxel and in colon cancer with a PD-one antagonist. And we have additional studies with eltonixor, our 2nd generation compound, moving on for myelodysplastic syndrome. And finally, I'll just remind that we have ongoing studies in glioblastoma, multi forming, where the drug has shown clear single agent activity with about a 10% confirmed response rate, and we'll be looking at Xpovio in combination with frontline therapies as well as in the relapse setting in GBM.
So That's just a small mattering of the kinds of things we'll be moving ahead aggressively with. As I mentioned, there's a lot going on here. And we're trying to hit on all of these cylinders. So that's what you can expect going forward with more indications to come at the end of this year and later next.
Got it.
Thanks. And second and final question, are you willing to comment on how the Boston study population breaks out by line of therapy?
We can't give additional details right now, but I think it's given the 9.5 month PFS, I think it's fair to say it broke out like a lot of these kinds of studies that you see in this in this line. So we'll be able to give a lot more color on all of this and all the details at an upcoming medical meeting.
Got it. Thank you. Congrats again.
Thank
Our next question comes from the line of Mike Uls from Baird. Your line is now open.
Hey guys, thanks for taking the question and congratulations on the data as well. Just had a question in terms of the strategy in Europe. So you mentioned filing in Europe here potentially adding in the Boston data. Just curious if there could be a slight change in timelines or if you have been in discussions with the EMA already here? And then secondly, just more broadly in terms of your strategy in Europe, now that you have positive Boston data, has that changed any at all?
Thanks.
Yes, thanks. I think in the first question, we shared the results with the EMA as we did with the FDA prior to the call. And we'll be engaging with them to figure out the most optimal path forward for Xpovio. Can you just hit the second question again, please?
Yeah, just your strategy in Europe, you kind of mapped out previously a couple of different scenarios of going into loan or partnering it things like that. And I'm just wondering is that still the case or if things changing now that you have this data in hand? Thanks. Yes,
thanks. This is Chris. So in general, I think the way that we're thinking about Europe is still relatively consistent with the way that we've talked about it before. We've talked about this sort of being 2 ends of the spectrum, right, a full out license partnership and then to go it alone. And then perhaps something in the middle more of a hybrid where you leverage our existing infrastructure, that you have in Europe.
So those are all on the table and we're actively exploring
all
of those options and we will certainly report back at the right time.
Got it. Thanks guys and congrats again.
Thank you. Thank you. Our next question comes from the line of Arlinda Lee from Canaccord. Your line is now open.
Hi, guys. Congratulations on the great data set. I am curious about the market research that you guys have done showing that you guys are moving into 3rd line. Can you talk more about when you thought that that might have happened and what might be driving that? And as well, just trying to figure out if you think that you could move earlier sooner than, I guess, an approval.
Thank you.
Let me take that one. So to be clear, we do believe that that is that those That utilization is consistent with our current label. As you recall, most patients in the myeloma treatment paradigm will get 2 to 3 drugs in each line of therapy. So there certainly is a small percentage of patients by the time that they get to the 3rd line who have already received the 5 major drugs or those classes of drugs that are in our approved label. So, so we believe that that, I think it was 3% of share estimate of net market research in the 3rd line.
We still believe that those are in fact patients who have already received the 5 2 proteasome inhibitors to, 2 imids and an anti CD30 antibody. In terms of moving, I guess, more fundamentally into the second and third lines, clearly that will be dependent on, a hopeful approval based on this Boston data.
Okay, great. Thank you. I would like to turn the call back over to CEO, Michael Kaufman for closing remarks.
Well, thanks again, everybody, and thanks for spending time with us on this very exciting day. We will talk to you soon, and have a great day. Bye bye.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.