Karyopharm Therapeutics Inc. (KPTI) Earnings Call Transcript & Summary

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 approval conference call. [Operator Instructions] 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, 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 XPOVIO for the treatment of patients with relapsed or refractory DLBCL. This is Ian Karp, and I'm joined today by Dr. Michael Kauffman, Chief Executive Officer; Mr. John Demaree, Chief Commercial Officer; Dr. Jatin Shah, Chief Medical Officer; Mr. Chris Primiano, Chief Business Officer and General Counsel; and Mr. Mike Mason, Chief Financial Officer. On the call today, Dr. Kauffman will review the details regarding the accelerated approval of XPOVIO for the treatment of adult patients with relapsed or refractory DLBCL and will describe some of the key clinical data which served as the basis for this approval. Following Dr. Kauffman's remarks, John will highlight the commercial landscape and opportunity for XPOVIO in the U.S. as well as the actions we are taking to support our second commercial launch in less than a year. We will 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 XPOVIO. 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 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, including as related to clinical development, regulatory matters and time lines, 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 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 10-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 Dr. Michael Kauffman, Chief Executive Officer.

Thank you, Ian, 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 for 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 Karyopharm. 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-19 pandemic. Furthermore, this is the second FDA approval, and it underscores XPO's potential benefit for patients beyond those with multiple myeloma. We hope that there will be many more approvals for XPOVIO in the years to come. As you may know, over-expression of the nuclear XPORT protein, exportin 1 or XPO1, the target of XPOVIO is observed across numerous tumor types, both in hematologic as well as in solid tumors. And nuclear XPORT dysregulation is increasingly recognized as a fundamental mechanism of oncogenesis. The agenda for today's call can be found on Slide 4. I will begin with an overview of DLBCL and the approval of XPOVIO as well as a summary of the SADAL study and our planned confirmatory Phase III clinical trial. I will then ask John Demaree to review the commercial landscape and opportunity for XPOVIO in 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 transplantation 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 third line or later. And this is precisely where XPOVIO can offer a new option to patients, as you will see on Slide 6. XPOVIO has now received accelerated approval from the FDA and is 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, XPOVIO'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 first 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 malignancies. Moving to Slide 7. As expected, there is also important safety information included in the updated XPOVIO product label. 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 XPOVIO. 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 XPOVIO'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 instructions, including the recommended supportive care guidelines and dosage modification criteria to be straightforward and easy for health care 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.xpovio.com. Now before I describe the efficacy and safety data that serves as the basis for XPOVIO's approval in 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 is no standard of care in the second or third line settings, response rates are only around 26 percent with additional traditional chemotherapy agents typically used in combinations. Thus, there remains significant unmet medical need, resulting in approximately 10,000 deaths in the 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 they're appropriate candidates following progression after a second-line treatment. However, for those patients who are not fit enough for a transplant or a CAR-T, or for those whose disease progresses after their second-line treatment with chemotherapy and rituximab, these patients will then require a third-line treatment option and for many additional treatment options in the fourth line or later. And this is the population with the greatest level of unmet medical need currently and for which XPOVIO has just received approval. Turning now to Slide 11. Let us now briefly review the SADAL study, which has served as the basis for XPOVIO'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 as just announced, granted XPOVIO 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 subtypes 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 complete response and 16% achieving a partial response. Additionally, the median duration of 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-point 1 months for nonresponders is also consistent with other benchmark trials 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 with non-GCB type of disease. These data are also encouraging 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 patients 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 91 years old. The median number of prior therapies was 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 XPOVIO for treatment. Treatment of relapsed/refractory multiple myeloma. The most common treatment-related nonhematologic 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 3, 4 AEs were thrombocytopenia, lymphopenia, 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 of myeloma patients which use a twice-weekly dose of 80 milligrams. Finally, before I transition the call to John to discuss the commercial landscape of DLBCL. You'll find on Slide 17 and 18, the design of our Phase II/III trial that will serve as the confirmatory studies for XPOVIO's accelerated approval in DLBCL. In the Phase II portion of the study, we plan to study 2 different doses of selinexor once-weekly in combination with rituximab and chemotherapy regimen called GDP, which includes gemcitabine, dexamethasone and the P stands for a platinum-based drug, cisplatinum or carboplatin. Primarily, safety and antitumor activity of this SR-GDP combination have been communicated to us from the French LYSARC group, who is conducting an investigator-sponsored trial utilizing this regimen, primarily in transplant eligible patients. Based on the data generated in the Phase II 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 322 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 Demaree, who will review the commercial landscape as well as our launch plans before we head into the Q&A portion of the call. John?

Thank you, Michael. And let me start by saying how great it is to join you on today's call to highlight the preparations we have made to support a successful commercial launch for XPOVIO in relapsed/refractory DLBCL. Turning to Slide 20. The total market for U.S. drug sales and relapsed or refractory DLBCL is expected to rise dramatically from less than $800 million in 2018 to over $3 billion by 2028 and 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 9,000 treated in the third line and later, many of whom we believe will be appropriate candidates for treatment with XPOVIO. 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 XPOVIO 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, XPOVIO. 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 that they can take at home rather than one that requires frequent visits to a hospital or cancer clinic. We plan to target our sales and marketing activities towards the roughly 3,000 physicians in the 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 XPOVIO, 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 the 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, XPOVIO 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 GCB 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 second approval for XPOVIO 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 for patients with multiple myeloma after at least one prior line of therapy. Next, XPOVIO 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 and utility for XPOVIO and demonstrates XPOVIO'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 patients, 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. And with that, operator, we'll open it up to questions.

[Operator Instructions] Our first question comes from Brian Abrahams with RBC Capital Markets.

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.

We'll turn that over to Jatin Shah for an answer.

Yes, 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 than 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. So a lower starting dose in a different patient population, where now we're looking at patients with 2 lines of therapy and not 7 lines of therapy. And dose reductions are labeled -- or 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. So we think that with this lower dose, we'll see less thrombocytopenia than we saw in the STORM, and then we have the appropriate dose reductions in here -- in the package insert.

Got it. That makes sense. And then on the XPORT-DLBCL-030 study, can you talk about the different dosing there, the weekly dosing? And how you're thinking about efficacy and safety of that dose, maybe based on both SADAL and some of the earlier investigator-sponsored work looking at selinexor in combination with 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 II to Phase III when you might expect to reach that point.

Thanks, Brian. I'll just briefly answer. That's a lot of stuff. Basically, we're testing 40 milligrams and 60 milligrams used during the therapy with R-GDP. And because as we did in -- remember in 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 the Phase III. It's albeit one protocol, and it's built in as a Phase II/III.

Our next question comes from Maury Raycroft with Jefferies.

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 XPOVIO 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 Demaree who can comment as well. I think the point here is that the good news for patients, and that's what ultimately matters, is that there are now -- there are going to be multiple options and are now several options available for patients with relapsed/refractory disease beyond sort of recycling chemotherapy that largely kills by the same mechanism. So now we have recently accelerated approval of the triplet parenteral therapy, polatuzumab with bendamustine-rituximab, pola-BR, which can induce responses, some of them are prolonged. We have our -- we have the next approval. This is, primarily these are in the non-CAR-T eligible populations of patients, and we have the tafasitamab plus Revlimid 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 first-line or sometimes second line therapy, and perhaps for some patients who get CAR-T therapy and have a durable complete response, there really is no cure for this disease. So the benefits for patients will come as there become multiple options for DLBCL and to treat recurrent disease. And until we have a cure for DLBCL in these patients who don't respond to their initial therapy, don't -- aren't cured in their initial therapy, we're going to need multiple therapies. We remain a 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-19 era. And in addition, we provide a completely different and novel mechanism of action for patients with this incurable malignancy. So those are some of the thoughts that will go through doctors' 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, I completely agree. It's good news for patients to have multiple options in terms of how XPOVIO will compete effectively, even with the recent FDA approvals and anticipated future approvals, there will remain a high unmet need because of the poor 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 oncologist and 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 as, again, there's still significant unmet need and many options for patients are needed as possible.

That's great. That's very helpful. And this is a second question. At EHA, you guys reported a lot of data updates there. I think one of the key takes is that we see the drug working in a broad subsets of patients, including the GCB and non-GCB. Just wondering if you can contextualize the data there. I think there was also a post hoc analysis on mutations and some biomarkers of interest, too. I guess, how can this inform commercial use of the drug?

Jatin, if you can speak briefly on the different subpopulations we showed activity?

Yes, absolutely. So at EHA, we actually had a couple of abstracts, specifically on patients' overall survival and the 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. So regardless of really which subset of patients you we 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 refractory disease, those patients also benefited as well. So I think it's important when you're looking at this with a different mechanism action that regardless of prior therapies and/or less response to prior therapies, these patients all benefited or had opportunity to benefit.

Our next question comes from Eric Joseph with JPMorgan.

Congrats on the approval, guys. I guess, my first is -- well, a couple of commercial questions here. One related to product packaging and price. So should we anticipate additional package format specifically for DLBCL? And if so, how did you price -- should we anticipate pricing in line with myeloma? And then secondly, if we're kind of just looking to the 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?

Maybe, Ian, you can take the second question first and then turn it over to John.

Sure. Yes, 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. Thanks for the question, Eric. Yes, we have introduced 3 new package sizes, all in line with the dosing recommendations in our package insert that Jatin 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 cost or WAC. 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 one follow-up, clinically. Are there other combination regimens that you anticipate exploring in addition to the 030 study?

Yes. I'll let Jatin take that and specifically focus on our 025 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 it in combination with GDP. We're going to be looking at another study called study 025. In that study, we're really going to look at multiple different combinations. So it 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 a 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 tafasitamab or more to it than the L-MIND data set. And then we'll look at a combination with selinexor plus polatuzumab and BR, additional kind of standard regimens that are approved currently. And yes, so those are the combinations that we'll looking at in the study 025.

[Operator Instructions] Our next question comes from Peter Lawson with Barclays.

Congrats on the approval. This is Mitchell on for Peter. Just had a couple of questions. The first one, can 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 6 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, the size of the market and the number of potential patients and educating on the SADAL study. These educational interactions have been well received. Our initial discussions with the payers to date lead us to believe that XPOVIO will be covered, reimbursed in a quick manner and in line with the FDA indication. The -- similar to our indication in penta-refractory multiple myeloma. There is a high unmet need for patients. Payers recognize this, and we expect very broad reimbursement and access from the beginning.

Mike, do you want to comment on the -- quickly, Mike, do you want to comment on the growth?

Yes. Yes, sure. Yes. So we -- no change in really what we've seen the last year or so of launch, and we will be somewhere in that range of 15% to 20% with some variability quarter-to-quarter.

Perfect. 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 myeloma?

Yes. So all over John.

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 our field teams have been provided additional tools to virtually engage with 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 planned as well to support field force efforts, including peer-to-peer programs to expand our commercial reach, nonpersonal promotion, including the electronic medical record information at the point of diagnosis, search engine marketing and media placement. So we've watched and learned and leveraged best practice as we've seen in the digital environment to hopefully maximize the launch right out of the gate with the DLBCL.

Our next question comes from Jonathan Chang with SVB Leerink.

Congrats on the approval. First question, how are you thinking about the size of the DLBCL commercial opportunity for XPOVIO, especially compared to your thoughts on the opportunity in 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 6,000 patients per year in the U.S. that were eligible for treatment with XPOVIO in the penta-refractory multiple myeloma setting. There are about 10,000-plus patients available for therapy -- sorry, 9,000 patients eligible for therapy in relapsed/refractory DLBCL. So the size of the potential patient population 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 XPOVIO 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, you -- can you share what we can at this point?

Yes, sure. Let me share what we can. Thanks, Jonathan, for the question. Yes, 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 than 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 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 progressed to get better since. But we're not going to break out detail in terms of sales numbers on a monthly basis at this point. But we'll certainly update investors when we report our second quarter earnings.

And our next question comes from Arlinda Lee with Canaccord.

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's going on with the myeloma filing? And maybe what is gating to the lymphoma filing?

Yes. Can you hear me?

Yes.

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, is the complexity of rules that govern multiple indications, multiple lines of therapy vis-à-vis STORM versus BOSTON and then separately in DLBCL in Europe. So we'll update when we can. We don't have an update now. And as we mentioned, we do have a 3-month extension on the STORM filing as we clean some of the -- do the remonitoring of some of the data that was requested by the European regulatory authorities.

Okay. So we'll get an update on the myeloma filings and then at some point later than this...

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.

And I'm currently showing no further questions at this time. I'd like to turn the call back over to Michael Kauffman for closing remarks.

Well, thanks, everybody, very much for joining us on this really unique day. It's just been phenomenal. And we think, again, this is really a great day for patients because this is a very, very difficult disease. As you heard, there are 9,000 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 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.