Good afternoon. My name is Shannon, and I will be your conference operator today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics DLBCL of Conference Call. 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, Karyopharm's Vice President of Investor And Public Relations.
Thanks so much, Shannon, and thank you all for joining us on today's conference call to discuss the accelerated FDA approval of Xpobio for the treatment of patients with relapsed or refractory DLBCL. This is Ian Karp, and I'm joined today by Doctor. Michael Kaufman, Chief Executive Officer Mr. John Denley, Chief Commercial Officer Doctor. Jatin Shaw, Chief Medical Officer Mr.
Chris Primiano, Chief Business Officer And General Counsel and Mr. Mike Mason, Chief Financial Officer. On the call today, Doctor. Copper will review the details regarding the accelerated approval of Expelvio the treatment of adult patients with relapsed or refractory DLBCL, and we'll describe some of the key clinical data which served as the basis for this approval. Following Doctor.
Kaufman's remarks, John will highlight the commercial landscape and opportunity for EXBOMIO in the U. S, as well as the actions we are taking to support our second commercial launch in less than a year. We'll then open up the call to answer your questions. Earlier today we issued a press release detailing the accelerated approval of our newest indication for Xplio. This release, as well as this webcast presentation, are available in the Investors section on our website at karyopharm.com.
Before we begin our formal comments and for those following along in the slide presentation, please turn to slide 3 and I'll remind you that various remarks we'll make today constitutes 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, including as related to clinical development, regulatory matters and timelines, the potential success of our products and product candidates including our expectations related to the commercialization of Xpovio, financial projections and plans and prospects. Actual results may differ materially from those infected indicated by these forward looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent quarterly report on Form Ten Q, 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. While we may elect to update these forward looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change.
Therefore, you should not rely on these forward looking statements as representing our views as of any date subsequent to today. With that, I'll now turn the call over to Doctor. Michael Kaufman, Chief Executive Officer.
Thank you, Ann, and good afternoon, everyone. I am very thrilled to be with you today to formally announce the second accelerated approval by the FDA for Xpovio, Karyopharm's lead selective inhibitor of nuclear export compound, which is now indicated to the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma, including DLBCL arising from follicular lymphoma. This is a landmark day for carryover arm. But more importantly, this is a landmark day for the thousands of patients battling relapsed or refractory DLBCL. Who now have a new oral single agent treatment option available for their disease.
This is really I want to reiterate what a really important day this is because until this day, there has never been a single agent oral therapy approved by the FDA for relapsed or refractory diffuse large B cell lymphoma. These are important at any time, but even more so during this COVID-nineteen pandemic. Furthermore, this is the second FDA approval and it underscores XBO's potential benefit for patients beyond those with multiple myeloma. We hope that there will be many more approvals for Xprobio in the year to come. As you may know, overexpression of the nuclear export protein exports in 1 or Xp01, the target of Xpovio is observed across numerous tumor types, both in hematologic as well as in solid tumors, and nuclear export dysregulation is increasingly recognized as a fundamental mechanism of Elanco Genesis.
The agenda for today's call can be found on Slide 4. I will begin with an overview of DLBCL and the approval of Bovio, as well as a summary of the SADAL study and our planned confirmatory Phase III clinical trial. I will then ask John Demery to review the commercial landscape in opportunity for Xpovio and DLBCL before we open the call up to your questions. Turning now to Slide 5. DLBCL is the most common type of non Hodgkin's lymphoma.
There are more than 30,000 new patients in the U S each year, but unfortunately, there are limited treatment options for patients in the relapsed or refractory setting. Most patients in frontline setting will receive treatment with a combination of rituximab and chemotherapy such as R CHOP, the current standard of care. And thankfully, Roughly 50% to 60% of these patients will either be cured or will have long term durable remissions following this regimen. Unfortunately, about 40% to 50% of the patients will continue to have their disease that progresses, including many of the patients who go on to receive additional intensive chemotherapy followed by autologous stem cell transportation or CAR T therapy. Patients and physicians desperately need new treatment options, especially for those patients who are not eligible for stem cell transplant or CAR T therapy.
And there is currently no standard of care in the 3rd line or later. And this is precisely where Xbovio can offer a new option to patients, as you will see on Slide 6. Exposvio has now received accelerated approval from the FDA and has indicated for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma not otherwise specified, including DLBCL arising from follicular lymphoma after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Importantly, Xpovio is now the only single agent oral therapy approved for the treatment of patients with previously treated DLBCL. Additionally, Xprobio's approval to treat patients with DLBCL that arises from follicular lymphoma is especially important as these patients typically have a poor prognosis and few drugs have proven effective in this patient subgroup. Additionally, Xpovio is now the 1st and only drug of any type approved by the FDA for use in both multiple myeloma and DLBCL that has relapsed after prior therapies. This speaks to the breadth of utility for Xpovio and demonstrate Xpovio's ability to work across different malignancy. Moving to Slide 7.
As expected, there is also important safety information included in the updated EXPOBIO product line. Notably, there are still no black box warnings or contraindications in the label. A patient medication guide is available to educate patients on the expected adverse reaction profile for Expevio. Additionally, there are some important details regarding patient monitoring instructions and warnings and precautions included. All of these details are consistent with the safety information previously included in Expobio's label, based on its accelerated approval last year for the treatment of patients with relapsed or refractory multiple myeloma.
We continue to expect these disruptions including the recommended supportive care guidelines and dosage modification criteria to be straightforward and easy for healthcare providers and patients to follow. Finally, it is recommended that adverse reactions be addressed using dosage modifications and supportive care with specific recommendations for both included in the prescribing information. Complete details of these guidelines, along with the complete prescribing information, can be found at www expobio.com. Now before I describe the efficacy and safety data that serves as the basis for Expobio's approval of patients with DLBCL, it's important to highlight the current level of unmet medical need in patients with relapsed or refractory disease. As you can see from Slide 8.
From 3 different benchmark clinical trials evaluating the treatment of patients with relapsed or refractory diffuse large B cell with a variety of chemotherapy combination regimens, patients who do not have a partial or complete response to currently available treatment options, unfortunately, have an expected median overall survival of 5 months or less. Additionally, While there's no standard of care in the second or third line settings, response rates are only around 26% with additional traditional chemotherapy agents typically used in combinations. Thus, there remains significant unmet medical need resulting in approximately 10,000 deaths in U. S. Each year from relapsed or refractory DLBCL.
The treatment landscape in 2020 and beyond can be seen on Slide 9. As mentioned previously, for the approximately 40% of patients who are not cured by their initial treatment and have progressive disease, If they are fit or healthy enough, they often go on to get another course of rituximab with another chemotherapy backbone followed by a stem cell transplant. Some patients may also go on to receive CAR T therapy if there are appropriate candidates following progression after a second live treatment. However, for those patients who are not fit enough for a transplant or CAR T or for those whose disease progresses after their second line treatment with chemotherapy, and rituximab, these patients will then require a 3rd line treatment option and for many additional treatment options in the 4th line or later. And this is the population with the greatest level of unmet medical need currently and for which Espovio has just received approval.
Turning now to Slide 11. Let us now briefly review the SADAL study, which has served as the basis for EXBOCA's accelerated approval. We first reported positive top line data at the American Society of Hematology annual meeting in December 2018 and subsequently submitted an sNDA at the end of 2019. The FDA granted our application for a priority review and has just announced, granted Xprobio accelerated approval before our official PDUFA date, which is tomorrow. The SADAL study included 134 patients who had previously been treated with at least 2 prior multi agent therapies and included patients with both GCB and non GCB subtype of DLBCL as well as patients with either de novo or transformed disease arising from follicular lymphoma.
Patients received a starting dose of 60 milligrams of selinexor given orally twice per week. On slide 12, you will see the key efficacy results from the study, which demonstrated an overall response rate of 29% including 13% of patients achieving a complete response and 16 response was 9.3 months with nearly 40% of the responders remaining on therapy and in responses for at least 6 months. Additional efficacy data from the SADAL study included overall survival data as seen on Slide 13, which further supports our intention to conduct a randomized trial. Specifically median overall survival for the total population was 9 months. For patients who had a partial or complete response, the median overall survival had not been reached as compared to 4.1 months for patients who did not respond to selinexor or who had progressive disease.
What this also means is that for patients enrolled in the SADAL study who did not have a response, there apparently was no effective rescue therapy for them. Finally, note that the short median overall survival of 4.1 months for non responders is also consistent with other benchmark trial I highlighted a few minutes ago, underscoring just how high the level of unmet medical need is in this population with relapsed refractory DLBCL. Slide 14 provides some additional efficacy data, which highlights the percentage of maximal tumor volume reduction by patient in a waterfall plot. Recall that all patients entering the study come in with progressing disease, which means their DLBCL is growing, at the time of their PET CT scans entering the study. In total, following initiation of selinexor treatment 62% of the patients had at least some reduction in tumor volume.
Tumor shrinkage was noted both in patients with GCB as well as and further support additional clinical development at DLBCL, particularly in combination with other active agents. As we now move to Slide 15, You will see that the patient studied in SADAL had a variety of characteristics that can often lead to a poor prognosis, which makes the efficacy results from this study even more noteworthy. The median age in the study was 67 years, with the oldest patient being ninety one years old. The median number of prior therapies with 2 with 34% of the patients previously treated with 3 or more prior regimens. Finally, 53% of patients have disease relapse less than 1 year from their first DLBCL treatment, a particularly poor prognostic feature associated with reduced overall survival.
The safety profile observed in SADAL was qualitatively consistent with the established and approved safety profile of exposure for treatment. Treatment of relapsedrefractory multiple myeloma. The most common treatment related non hematologic adverse events were fatigue, nausea, decreased appetite and diarrhea, They were primarily grade 1 and 2, and most were reversible and manageable with standard dose modifications and or supportive care. The most common grade 34AEs were thrombocytopenia, neutropenia, neutropenia and anemia, and most were also reversible and manageable with dose modifications. And or supportive care.
Importantly, the frequency of the Grade 3 or 4 side effects observed in the SADAL study using a twice weekly dose of 60 milligrams was lower than that observed in the STORM study in myeloma patients, which use a twice weekly dose of 80 milligrams. Finally, before I transition the call to John to discuss the design of our phase twothree trial that will serve as the confirmatory studies to support Xpovio's accelerated approval in DLBCL. In the phase called GDP, which includes gemcitabine, dexamethasone, and the P stands for a platinum based drug, cisplatinib or carboplatin. Primarily safety and antitumor activity of this SR GDP combination have been communicated to us from the French Lifesert group who is conducting an investigator sponsored trial utilizing this regimen, primarily in transplant eligible patients. Based on the data generated in the phase 2 portion of our trial, We expect to take the most appropriate dose of selinexor into the Phase III portion where we plan to enroll approximately 3 22 patients with progression free survival as the primary endpoint of the trial.
We currently expect to begin the study in the third quarter of this year and look forward to providing updates as the trial progresses. With the review of the clinical information now complete, I'd like to turn the presentation over to our Chief Commercial Officer, John Demery, will review the commercial landscape as well as our launch plans before we head into the Q And A portion of the call. John?
Thank you, Michael. And let me start by saying how great it is to successful commercial launch for Xpovio and relapsed refractory DLBCL. Turning to Slide 20. The total market for U. S.
Drug sales in relapsed or refractory DLBCL is expected to rise dramatically from less than $800,000,000 in 20.18 to over $3,000,000,000 by 2028, driven largely by the introduction and adoption of new treatment options, and the increase in life expectancy from these new treatments. As you can see on slide 21 there are roughly 57,000 DLBCL patients treated each year in the U. S. With approximately 9000 treated in the 3rd line and later many of whom we believe will be appropriate candidates for treatment with Xpobio. Turning to Slide 22, The commercial strategy for Xpovio in this patient population has been developed via extensive market research, advisory boards, and interactions across different stakeholders.
We plan to successfully launch Expevio as the preferred DLBCL treatment option after 2 prior lines of therapy instead of traditional intravenous chemotherapy by educating physicians on the deep and durable efficacy achieved in clinical studies with oral, single agent, novel, expovio. Currently according to recent market research, approximately 38% of transplant ineligible patients receive traditional chemotherapy in this setting. Importantly, Xpovio offers compelling efficacy with a manageable safety profile and is now the first oral therapy approved for relapsed or refractory DLBCL, the first single agent approved in any line of DLBCL treatment and the first therapy of this kind that a patient can take at home. We believe these features are particularly important for many community based patients who have already received multiple rounds of combination chemotherapy and are looking for an active therapy as they can take it home. Rather than one that requires frequent visits to a hospital or cancer clinic.
Activities towards the roughly 3000 physicians in U. S. Who treat 80% of all DLBCL patients. With about 75% of these physicians residing in the community based setting. Our Karyopharm U.
S. Sales force of approximately 70 individuals was already sized in anticipation of this launch and there is greater than 50% overlap between our key myeloma and DLBCL physician targets. So needless to say, we feel highly confident that we'll be able to hit the ground running as we roll out our launch initiatives. Our core focus with our communication efforts will be to highlight the key features of Expobio, which can influence treatment decisions. These can be found on Slide 23.
The most important feature of Xpovio is its clinical efficacy which resulted in meaningful and deep responses as illustrated by the results of the SADAL study that Michael just reviewed. Including a 29% overall response rate and a clinically meaningful duration of response with a median of 9.3 months. In addition to a compelling efficacy profile, EXPovio also offers physicians and patients, a novel mechanism of action to target the disease, versus reusing a therapy patients are refractory to efficacy seen across both ABC and GCD patient subtypes, a manageable safety profile that does not include organ toxicities and an oral single agent treatment option that can be taken at home without the need for intravenous chemotherapy. Based on our market research and feedback from advisory boards, We believe these core features will be well received by physicians and patients alike. Our commercial team is energized to help more patients and is ready to launch We are initiating our launch activities immediately, and I look forward to providing an update on our commercial progress in the months to come.
With that, I'd like to just quickly review a summary of today's call before we open things up to your questions. First, today's approval in DLBCL marks the 2nd approval for Expobio in less than a year. Additionally, we're also excited that a third NDA has already been submitted to the FDA requesting an expansion of Xpovio's label as a potential new treatment patients with multiple myeloma after at least one prior line of therapy. Next, Espovio is now the only single agent oral therapy approved for the treatment of patients with relapsed or refractory DLBCL, and it is also the first and only therapy approved to treat both multiple myeloma and DLBCL. This speaks to the breadth of utility for Xpovio and demonstrate exposio's ability to work across tumor types.
And as I mentioned previously, we will begin our commercial launch immediately and our commercial infrastructure is already in place to advance our commercial goals. Finally, we would like to take this moment to say a special thank you to all of the caregivers, physicians, advocacy organizations, Karyopharm employees and investors in our company who helped us get to this monumental day, we could not have achieved this important milestone for patients without your support and we celebrate today's news with all of you. Thank you.
You. First question comes from Brian Abrahams with RBC Capital Markets. Your line is open.
Congratulations on the second approval. Just a couple for me. I guess, first off, I was wondering if you could talk a little bit about how you might anticipate safety management in this indication, particularly for thrombocytopenia and how that might be similar to or different from myeloma, any additional changes in educational efforts that you expect?
And then
I had a follow-up.
I'll turn that over to Jake and Shah for an answer.
Yeah, absolutely. Thanks so much. So I think a couple of things, one is that we anticipate to see less thrombocytopenia than we saw on storm. For 2 major reasons. One is the patient population that we saw in myeloma had much more myelosuppression in 7 lines of prior therapies.
What we see in large cell lymphoma is lower dose of 60 milligrams twice a week compared to 80 milligrams twice a week in the myeloma a lower starting dose in a different patient population, whereas now we're looking at patients with 2 lines of therapy and not 7 lines of therapy. And, those reductions are labeled in the package insert where specifically the first dose reduction is to 40 milligrams twice a week and the second dose reduction is to 60 milligrams once a week. We think that with this lower dose, we'll see, less thrombocytopenia we saw in the storm. And then we have appropriate dose reductions in the year in the package insert.
Got it. That makes sense. And then on the X report DLBCL-three zero study. Can you talk about the different dosing there, the weekly dosing and how you're thinking about efficacy and safety at that dose maybe based on both Saddle and some of the earlier investigator sponsored work looking at selinexor in combination with was rice for instance? And then also just wondering if you could comment on what the criteria would be for selecting the dose to move from phase 2 to phase 3 when you might expect to that point and I'll hop back in the queue.
Thanks.
Thanks, Brian. I'll just briefly answer. That's a lot of stuff. Basically, we're testing 40 milligrams 60 milligrams used during the therapy with our GDP. And because as we did in remembering Boston in myeloma, We used a much lower dose of selinexor once weekly with combination therapy Velcade and had a very nice, significant benefit over standard velcade therapy.
So again, we'll be taking advantage of the synergies that we see between selinexor and many other anticancer drugs here. In this case, chemotherapy with rituximab. We'll be looking at the 2 different doses and we will be, primarily using efficacy rates, ORR, overall response rates in the initial arms of the study to select, which dose can go forward into Phase III. It's all be one protocol and it's built in as a Phase IIIII. Thanks.
Thank you. Our next question comes from Maury Raycroft with Jefferies. Your line is open.
I guess the first question is just on the competitive landscape. It's kind of the most common question that I get about DLBCL. If you can just talk more about, some of the competitors that are in development and how you think Xpovea will compare and contrast based on safety and efficacy, that you've got with the program.
Yes, maybe I'll start and then I'll turn it over to John Demery in comments as well. I think the point here is that the good news for patients and that's what ultimately matters is that they are now they're going to be multiple options and now several options available for patients with relapsedrefractory disease beyond sort of recycling chemotherapy that largely kills by the same mechanism. So now we have recently an accelerated approval of the triplet parenteral therapy, polatuzumab with bendamustarutuximab, polobr which can induce responses. Some of them are prolonged. We have our now we have the next approval.
This is primarily, these are in the non CAR T eligible populations of patients. And we have the tafasitumab plus Revelinib that's coming up, I think, in a couple of months. And the good news is, hopefully patients will have access to all of these because unfortunately, once patients progress beyond 1st line or sometimes second line therapy and perhaps for some patients who get CAR T therapy and have adorable complete response, there really is no cure for this disease. So the benefits for patients will come as there become multiple options for DLBCL to treat recurrent disease. And until we have a cure for DLBCL in these patients who don't respond, to their initial therapy.
You don't aren't cured in their initial therapy. We're going to need multiple therapies. We remain unique therapy and we're the only single agent that is on the docket right now that we're aware of to be approved in this indication. We offer some unique qualities. Some of these are very important in the COVID-nineteen era.
And in addition, we provide completely different and novel mechanism of action for patients with this incurable malignancy. So those are some of the thoughts that we'll go through Doctor. Minds and patients as they choose their therapy. But ultimately, the goal would be that patients could receive any of these new therapies as their disease recurs. John?
Yes, completely agree. It's good news for patients to have multiple options in terms of how Expevia will compete effectively. Even with the recent FDA approvals and anticipated future approvals, there will remain a high unmet need because of the core outcomes in these patients who relapse after 2 or more therapies. Right now, there really is no established standard of care for these patients and physicians are looking for an effective and tolerable treatment option. With Xpovio, we've seen a compelling profile that tests well in market research.
And what we found is that Xpovio fills an existing and future unmet need gap for these patients, even with the advent of newer therapies, which is why it received breakthrough therapy designation and approval by the FDA. In the context of the research that we completed, the oncologists, hematologists have shared that they plan to use Xpovio before these options in some cases. In some cases after these options and others, depending on a patient's profile, again, there's still significant unmet need and many options for patients are needed as possible.
That's very helpful. And this is, second question at EHA, you guys reported a lot of data updates there. I think one of the key takes is that you see the drug working in a broad subset of patients, including the GCB and non GCB. I'm just wondering if you can contextualize the data there. I think there was also a postdoc in analysis on mutations and some biomarkers of interest too.
I guess, how can this inform commercial use of the drug?
Jade, if you could speak briefly on the different subpopulations we showed activity?
Yes, absolutely. So EHA, we actually had a couple of abstracts, specifically on patients overall survival, and a benefit in patients overall survival benefit that we saw. We also showed activity of selinexor in patients with primary refractory disease, as well as based on prior therapies. Regardless of really which subset of patients were looked at, if they had prior transplant or not, and if they had really a very difficult disease, that's often excluded from other trials, which is patients with primary fracture disease, those patients also benefit as well. So I think it's important when you're looking at this with a different mechanism that regardless prior therapies, and our list of response to prior therapies, these patients all benefited or had a chance of an opportunity to benefit.
Thank you. Our next question comes from Eric Joseph with JP Morgan. Your line is open.
Thanks for taking the questions and congrats on the approval guys. I guess my first is a couple of commercial questions here, one related to product packaging and price. So should we anticipate additional package format specific specifically for DLBCL? And if so, how would it be priced to re anticipate pricing in line with myeloma? And then secondly, if we're just looking to, DLBCL factoring into top line sales, what, granularity should we be looking to behind sort of the top line number Should we expect you to be breaking out demand by myeloma versus DLBCL?
Thanks.
Maybe Ian, you can take the second question first and then turn it over to John.
Sure, happy to. I think certainly, I mean, certainly over time we will, as we get more data in and we can see the breakout of sales between lymphoma and myeloma, we will certainly communicate that to investors as well. So that's certainly something as we move out into the future, we should be able to do. And certainly, you can expect that. In terms of SKUs and pricing, maybe I'll let John handle that one.
Thanks, Ian. And thanks for the question, Eric. Yes, we have introduced 3 new package sizes all in line with the dosing recommendations in our pack gensurate that Jason described. Similar to our packages in the market today for multiple myeloma, each 28 day package will be priced the same at 22,000 wholesale acquisition costs or WACC. There are no changes to our current distribution plans where we do continue to utilize a small number of specialty pharmacies and specialty distributors and those new dosing packs will be available immediately for patients as needed.
Great. And I guess maybe just want to follow-up clinically. Are there other combination regimens that you anticipate exploring, in addition to the O30 study?
Yeah. Hi. I'll let Jatin take that and specifically focus on our 2five study, which we've briefly discussed in the past, but we'll get a little more detail now.
Yes, absolutely. Thanks so much. So in addition to the, 030 study, we're looking at combination with GDP. What are we looking at? Another study called study25.
And in that study, we really look at multiple different combinations of Mimics, our experience in Stomp where we looked at selinexor plus a number of other backbone chemotherapies or combination regimens. And so we'll be looking at, number of regimens The 4 that's going to be the first or prominent that we'll be looking at is in combination with lenalidomide and rituxan, the R squared regimen, We'll also be looking at a combination of selinexor plus lenalidomide and tap or more to wait from the LMI data set. And then we'll look at a combination with selinexor plus poletuzumab and BR additional kind of standard regimens that are approved currently. And yeah, so those are the combination that we're looking at in 2020, Study 25.
Our next question comes from Peter Lawson with Barclays. Your line is open.
Hi, everyone. Congrats on the approval. This is Mitchell on for Peter. Just had a couple of questions. The first one you provide any color on reimbursement expectations and what we can expect for gross to net adjustments?
Yes, put that over to John, please.
Glad to take that. Thanks for your question, Mitchell. Over the last six months, we've actively engaged with most of the national and larger the national and larger regional payers representing about 80% of insured lives in discussing disease awareness education in DLBCL besides the market and the number of potential patients and educating on a SADAL study. These educational interactions have been well received. Our initial discussions with the payers to date lead us to believe that Expevio will be covered reimbursed in a quick manner.
And in line with the FDA indication. So similar to our indication in the pantry refractory multiple myeloma, there's a high unmet need for patients peers recognize this and we expect very broad reimbursement and access from the beginning.
Great. Mike, do you want to comment
on the quickly? Mike, do you want to comment on the gross margin?
Yes,
sure. Yes, so we, no change in really what we've seen. The last year or so of launch, it would be somewhere in that range of 15% to 20% with some variability quarter to quarter.
Perfect. Thank you. And then, how do you expect virtual launch to impact uptake in DLBCL and what has been the feedback received so far in that virtual marketing? And then will carry forward be used to support the DLBCL launch as well? In addition to the model.
So all over to John. Great.
Yes. So to
answer your second question first, yes, carry forward will immediately incorporate and support the DLBCL patients. In terms of launching in the virtual environment, given the pandemic started in Q1, We've known for quite some time that a virtual launch would be necessary and we've been preparing accordingly. All of our field teams have been provided additional tools to virtually engage customers, we rapidly launched multiple digital tools to facilitate continued sales force engagement with customers. And the field team has been trained on how to utilize these tools with the appropriate promotional pieces in DLBCL. We also have a digital, a robust digital marketing effort plan as well to support the field force efforts, including peer to peer programs to expand our commercial reach, non personal promotion, including BLF economic medical record information at the point of diagnosis, search engine marketing and media placement.
So we've launched and learned and leveraged best practices we seen in the digital environment to hopefully maximize the launch right out of the gate with DLBCL.
Our next question comes from Jonathan Chang with SVB Leerink. Your line is open.
Hi, guys. Congrats on the approval. Thanks for taking my questions. First question, how are you thinking about the size of the DLBCL commercial opportunity for Xplovio, especially compared to your thoughts on the opportunity for multiple myeloma?
Great. I'll send that over to John.
So just looking at the size of
the potential patients in the different indicated settings. What we've discussed before, Jonathan, and thanks for the question, but there are about 6000 patients per year in the U. S. That were eligible for treatment with Xpovio in the pensory refractory multiple myeloma setting. There are about 10,000 plus patients available for therapy and sorry 9000 patients eligible for therapy in relapsedrefractory DLBCL.
So the size and potential patient population is a little bit longer, is a little bit longer in terms of duration and a little bit larger than the multiple myeloma patient population.
Got it. And second question, on your first quarter call, you indicated that the Xplovial launch in multiple myeloma experienced a rebound and was on a positive trajectory in April compared to 1Q. Any additional color at this point on how things have looked since then?
Ian, can you share what we can at this point?
Yes, sure. Let me share what we can. Thanks, Jonathan, for the question. Yeah, you're absolutely right. We had commented on our Q1 call that we were certainly encouraged that of the strength of the business in April.
We're now as you know close to the end of the second quarter. So I don't want to get into too much detail in terms of any kind of monthly or weekly trends. But what I will say is we continue to reiterate and believe that the second quarter, will in fact be stronger the first quarter, which is what we had said publicly on that call. We certainly have seen that we're adapting better. We think physician practices are adapting better.
Have figured out, you know, how to operate medical practices and pharmaceutical selling in this new COVID environment We've begun to see in some parts of the country representatives back able to see some of their customers. So it's our sense that for us at least, at the very beginning of or at least that March kind of was the most difficult time period for us and that things have progress to get better sense, but we're not going to break out detail in terms of sales numbers on a monthly basis at this point. But we'll we'll certainly update investors when we report our 2nd quarter earnings.
Thank you. And our next question comes from Arlinda Lee with Canaccord. Your line is open.
Hi guys. Congratulations on the approval. And, I had a couple of questions, maybe more focused on the European filings. Can you provide an update on what going on with the myeloma filing and maybe what is dating to the, lymphoma filing? Thank you.
Yeah.
Hi. Can you hear me? Yes. So, yes, so we will be we intend to be filing this in Europe before the end of the year. Pending our discussions with the regulators there around storm and Boston and the other different indications.
Part of the issue is the complexity of rules that govern multiple indications, multiple lines of therapy. Visavis storm versus Boston and then separately in DLBCL in Europe. So we'll update when we can. We don't have an date now. And as we mentioned, we do have a 3 month extension on the storm filing as we clean some of the do the re monitoring of some of the data.
That was requested by the European regulatory authorities.
Okay. Okay. So we'll get an update on the myeloma, filings. And then at some point later than the
Yes, because we can't we're not filing. Yes, we can't we have an open filing with them and we can't progress this one until we get that one sorted.
I see. Okay. Thank you very much.
Thank you. And I'm currently showing no further questions at this time. I'd like to turn the back over to Michael Kaufman for closing remarks.
Well, thanks everybody very much for joining us on this a really unique day. It's just been phenomenal. And we think again, this is really a great day for patients because this is This is a very, very difficult disease. As you heard, there are 9000 patients battling this every year and have a terrible prognosis. And we hope that selinexor could contribute to prolonging the quality of their lives and and continuing to help them pending full regulatory approval in the next trial.
But for now, they have another therapeutic option under the accelerated approval guidelines. And we wish everyone the best and thank everyone again for all their support during this great time. We'll talk soon. Bye bye.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.