Good morning. My name is Victor, and I'll be your conference operator for today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics conference call to announce the FDA's accelerated approval of XPOVIO. 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. Chris Primiano, Karyopharm's Chief Business Officer and General Counsel. You may begin.
Thank you, Victor. Thank you all for joining us on this very exciting occasion to discuss the FDA's accelerated approval of XPOVIO, also known as selinexor, for the treatment of adult patients with highly refractory multiple myeloma. This is Chris Primiano. I'm joined today by Dr. Sharon Shacham, Founder, President, Chief Scientific Officer, and inventor of XPOVIO, Dr. Michael Kauffman, Chief Executive Officer, Mr. Perry Monaco, Senior Vice President of Sales, and additional members of our executive team who will be available to answer questions in the Q&A portion of today's call. On the call today, Dr. Kauffman will provide an overview of the approved indication by the FDA for XPOVIO and will review some of the key clinical data that served as the basis for this approval.
He will also highlight the important actions we are undertaking so that patients and their caregivers are effectively supported throughout the treatment experience with XPOVIO. Following Dr. Kauffman's remarks, Perry Monaco will discuss the multiple myeloma market and will describe our commercial preparations and strategic plans to support a successful commercial launch in the United States. Perry joined Karyopharm in early 2018 to lead the development of our sales strategy and to build out our field-based sales organization. He has spent over 20 years in the commercial oncology hematology space, including more than seven years specifically in the multiple myeloma market, and has held key leadership roles in numerous oncology drug launches, including in multiple myeloma. Following Perry's remarks and some concluding remarks from Michael, we will open the call to answer your questions. Earlier today, we issued a press release detailing the accelerated approval of XPOVIO by the FDA.
This release, as well as this webcast presentation, is available in the Investors section on our website at karyopharm.com. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments and regulatory matters and timelines, the potential success of our product candidates, financial projections, our 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. You should not rely on these forward-looking statements as representing our views as of any date subsequent to today. I'll now turn the call over to Dr. Michael Kauffman, Chief Executive Officer of Karyopharm.
Thank you, everyone. Thank you, Chris. Good morning. Good afternoon. I want to thank everybody for joining us here. My voice is a little off today. As you can imagine, there's been a little bit of excitement around the company. I'm thrilled to be with you today to formally announce the accelerated approval by the FDA of XPOVIO, indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma, so-called RRMM, who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. This indication is approved under the FDA's accelerated approval program, developed to allow for expedited approval of drugs that treat serious conditions and that fill an unmet medical need.
The approval of XPOVIO is based on the efficacy and safety observed in a pre-specified subgroup analysis of part II of the STORM study, comprised of 83 patients whose disease was confirmed to be refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The ongoing phase III BOSTON study will serve as that confirmatory trial. We expect to have top-line results from the BOSTON study by the end of this year or early next year, depending on the occurrence of progression-free survival events in the trial. As many of you know, Karyopharm was founded about 10 years ago by Dr. Sharon Shacham to focus on the discovery and development of nuclear transport modulators.
Overexpression of the nuclear export protein, Exportin 1 or XPO1, is observed across numerous tumor types. Nuclear export dysregulation is increasingly recognized as a fundamental mechanism of oncogenesis by inactivating tumor suppressor and other growth regulatory proteins. Dr. Shacham set out to find compounds that could attenuate the abnormally high levels of nuclear export observed in cancer cells. In 2010, she discovered novel small molecule inhibitors of XPO1. This new class of agents was called selective inhibitors of nuclear export, or SINE compounds. Now branded XPOVIO, selinexor is the first SINE compound to enter clinical development in 2012.
A broad phase I program with an oral agent was undertaken in both hematologic and solid tumor malignancies, with evidence of anticancer activity reported in several areas. Based on the high unmet medical need and the initial phase I results, we decided to focus our clinical efforts on a population of patients with multiple myeloma whose disease was refractory to available agents and therefore whose prognosis was particularly poor. The STORM study for selinexor treatment of refractory myeloma was opened to XPOVIO in combination with low-dose dexamethasone in patients with highly refractory myeloma. Fast-forwarding to today, I am thrilled to announce today that XPOVIO is now the first and only nuclear export inhibitor approved by the FDA. Additionally, XPOVIO is now the first and only prescription medicine approved for adult patients whose myeloma is refractory to proteasome inhibitors, immunomodulatory agents, and an anti-CD38 monoclonal antibody.
As to be expected, there is also important safety information included in the XPOVIO product label. Notably, there are no black box warnings or contraindications in the label. A patient medication guide will be 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 in the label. We expect these instructions, including the recommended supportive care guidelines and dosage modification criteria, to be straightforward and easy for healthcare providers and patients to follow. Specifically, physicians are recommended to administer concomitant serotonin antagonists and/or other anti-nausea agents when prescribing XPOVIO and to monitor body weight during the treatment. Standard lab tests, including complete blood count and serum chemistry, are also recommended during treatment.
Finally, adverse reactions are recommended to be addressed by using dosage modifications and supportive care, with specific recommendations for both included in the prescribing information for the common adverse reactions associated with XPOVIO. Complete details of these guidelines, along with the complete prescribing information, can be found at www.xpovio.com. Before I describe the efficacy and safety data that served as the basis for XPOVIO's accelerated approval, it is important to understand just how heavily pretreated and vulnerable the patients were in our pivotal STORM study. This provides important context when reviewing the efficacy and safety data. In fact, currently available real-world data suggests that patients with this level of advanced refractory myeloma have a median life expectancy of between three and five months. 202 total patients were enrolled in STORM, with 122 patients enrolled in part II of the study.
All patients in part II of the study had been previously treated with the five standard of care myeloma drugs available. Additionally, there were specifically 83 patients confirmed to have disease refractory to the five drugs, which include bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab. The major efficacy outcome measure for XPOVIO was established based upon the overall response rate in these 83 patients who, in addition to having highly refractory disease, had been treated with a median of eight prior drug regimens over the last seven years and had 57% in high-risk cytogenetic markers, which further predict a poor prognosis. Additionally, the patients in part II of STORM had rapidly progressive myeloma with a median increase in disease burden of 22% in just the 12 days from screening to the patient's first dose of XPOVIO.
Not only did patients have heavily pretreated and progressive disease, they also had a median of 10 comorbidities, which included moderate to severe renal dysfunction and various cytopenias, including thrombocytopenia. Patients were allowed to be receiving any concomitant medications when they entered the study. We believe the patients enrolled in the STORM part II represent the kind of real-world patients with highly refractory myeloma that many treating physicians in the U.S. would expect to see in their clinics. Additionally, these patients had the most refractory disease included in any sizable myeloma clinical trial to date. I will now highlight some of the key efficacy data from the 83 patients in the study who served as the basis for XPOVIO's accelerated approval.
25.3% of these patients achieved a partial response or better, as defined by the International Myeloma Working Group, and as assessed by an independent review committee. Therefore, the study met its primary endpoint. Importantly, XPOVIO was able to achieve significant depth of response, with one patient out of 83 achieving a stringent complete response and another four patients achieving a very good partial response, which means a 90% reduction in their disease burden. Most patients who responded to XPOVIO achieved a response within the first four weeks of treatment, and the median duration of response was 3.8 months.
While it's important to highlight the overall response rate in the 83 patients who served as the basis for XPOVIO's accelerated approval, we believe that it's also important to have a broader perspective on the responses and overall survival data from the entire patient population in part II of the STORM study. These data were presented at ASH 2018. We have previously highlighted them in earlier investor presentations. Specifically, what you'll see on the left side of this slide is a waterfall plot of the responses of 122 patients in STORM part II . Remember, the patients entering part II of the study had rapidly progressing disease with a median 22% increase in disease burden in just 12 days between screening of the study and therapy initiation. The waterfall plot shows despite the rapid progression on study entry, 71% of the patients had a reduction in their disease burden.
Each of these bars represents the maximal tumor load reduction for each individual patient. These results show that most of the patients on part II of STORM experienced a halt to disease progression and a reduction in their disease burden. These results further support our rationale and enthusiasm for the ongoing randomized BOSTON study being conducted in patients with relapsed multiple myeloma after one to three prior therapies. Turning to overall survival. As I mentioned previously, patients who entered STORM part II with heavily pretreated and refractory myeloma have an expected median survival of only three to five months based on recent published literature. On the right side of this slide, you will see the overall survival data from the 122 patients in part II of STORM with a median of 8.6 months of overall survival across the whole patient population.
Also notable was the median survival seen in the nearly 40% of patients who had at least minimal responses to XPOVIO. These patients had a median overall survival of 15.6 months. This compares to a median survival of only 1.7 months in the patients whose disease progressed or was not evaluable in the study. As a reminder, these data come from all of the 122 patients in part II of STORM. We note again that the approved label indication for XPOVIO was based on the subset of 83 patients whose disease was confirmed to be refractory to all five of the standard of care myeloma drugs available today.
XPOVIO has a well-characterized safety profile, with more than 1,000 patients with hematologic malignancies treated in clinical trials to date, including 202 patients with myeloma who received oral XPOVIO 80 mg in combination with dexamethasone 20 mg on days one and three weekly in parts I and II of STORM. In the STORM study, the most common adverse event reactions with an incidence of over 20% were thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infections. The rate of fatal adverse reactions was 8.9%, and the treatment discontinuation rate in the study was 27%. The types of adverse reactions were consistent with what would be expected in older patients with highly refractory myeloma who've been heavily pretreated and many have underlying comorbidities.
Along these lines, 53% of the patients had a reduction in their XPOVIO dosage, and 65% of patients had the dosage of XPOVIO interrupted. These dose modifications to address adverse reactions were often effective for improving symptoms and reducing discontinuations. For example, 44% of patients had a dose modification to address an adverse reaction of thrombocytopenia, while only 3% discontinued treatment due to this adverse reaction. Based on the results from the STORM study, we believe that physicians will be able to detect, monitor, and manage adverse reactions through dose modifications and standard supportive care. Importantly, we are committed to educating and supporting patients and their caregivers and have developed five key initiatives to support XPOVIO use. First, we intend to educate prescribers and their staff about what to expect while on treatment with XPOVIO.
We are planning for a team of trained nurse liaisons to provide guidelines around the management of XPOVIO adverse reactions. Second, we have a dedicated network of specialty pharmacy staff and oncology-trained nurses available 24/7 and anticipate that myeloma advocacy groups will also support patients to help optimize their treatment. Next, as per the label, we intend to recommend regular monitoring of complete blood count, basic serum chemistry, and body weight. Fourth, we plan to communicate the management of common adverse reactions with clear guidance on dosage modifications and supportive care that should be delivered prophylactically or as needed. Finally, we expect to communicate clear stopping criteria for disease progression in one to two months or for significant adverse reactions despite those modifications and supportive care.
With the review of the efficacy and safety data now complete, I'd like to turn the presentation over to our Senior Vice President of Sales, Perry Monaco, who will review our commercial launch plans, then I'll make some final remarks before we head into the Q&A portion of the call. Perry?
Thank you, Michael. It's great to join you on this call to highlight the preparations we have made to support a successful commercial launch of XPOVIO. Before I describe our specific commercial plans, I want to provide a brief description of the multiple myeloma landscape where there remains a significant need for additional novel treatment options. Multiple myeloma is the second most common blood cancer in the U.S., with roughly 32,000 new cases each year and 130,000 patients living with the disease. It's a disease that disproportionately affects our aging population with a median age at diagnosis of 69 years old. While there have been a number of new treatments approved in recent years, regrettably, the disease remains incurable, and the vast majority of patients will develop disease refractory to the currently available treatment options.
Unfortunately, there are expected to be nearly 13,000 deaths due to multiple myeloma this year in the U.S. Of the patients in the U.S. living with multiple myeloma, it is estimated that roughly 69,000 patients will be treated with drug therapy annually. While we cannot predict with certainty how many of the relapsed refractory patients will be appropriate candidates for XPOVIO, we estimate that there are approximately 6,000 patients being treated with their fourth or later line of therapy, and we know that patients typically receive between two to four different drugs in combination in each line of therapy. With the approval of XPOVIO, our commercial team will now be focusing on four core launch imperatives. First, our goal will be to establish nuclear export inhibition as a novel, fundamental approach in the treatment of multiple myeloma.
Our second goal will be to position XPOVIO as the oral agent of choice with a clinically meaningful efficacy profile in patients with disease refractory to at least two proteasome inhibitors, at least two immunomodulatory agents and an anti-CD38 monoclonal antibody. Next, we will seek to minimize potential access barriers to support appropriate patients starting and staying on therapy. Finally, we plan to educate healthcare providers and patients on the adverse reaction profile of XPOVIO and the related management strategies, which you heard Michael outline earlier on the call. A successful commercial launch in 2019 will also help set the stage for potential future launches and additional indications in both myeloma and across tumor types currently in clinical development, pending future regulatory approvals, of course.
While the recommended starting dose for XPOVIO is 80 mg taken twice per week, we do expect physicians to tailor the dose to best meet the needs of each individual patient, a practice that is common for many cancer medications. In order to support dosing flexibility, we intend to launch XPOVIO in four different, four-week dosing package sizes of XPOVIO 20 mg tablets. As we believe the value of XPOVIO to the patient is independent of what dosing regimen is most appropriate, we have decided to price all four available dosing packages at the same wholesale acquisition cost of $22,000 per month. We do not believe pricing considerations should influence what dose of XPOVIO a patient is prescribed; therefore, we have decided to take this flat pricing approach.
As we have been preparing diligently for FDA approval, I am happy to announce that we have an ample supply of XPOVIO already manufactured, we will expect XPOVIO to be commercially available to patients on or before July 10th, 2019. As we now prepare to launch XPOVIO to healthcare providers, I'd like to share some high-level insights we have learned from recent market research with 120 myeloma-treating physicians. First, nearly 80% of these physicians are already aware of XPOVIO. Next, nearly 50% feel they do not currently have effective treatment options for fourth-line-plus patients, they believe the kinds of patients studied in the STORM trial represent a patient population with particularly high unmet need. In terms of their perceptions of XPOVIO, they believe its most significant advantage is its novel mechanism of action and resulting efficacy. They also believe its oral administration is a meaningful benefit.
Finally, they share our view that the adverse reaction profile is likely manageable but will require proactive communication to optimally support both physicians and patients. I am pleased that our sales, marketing, and account management teams are already fully hired, trained, and ready to launch XPOVIO immediately. We have hired and trained more than 70 sales representatives and nurse liaisons. They will focus on the 1,300 accounts who treat roughly 80% of all multiple myeloma patients, with an emphasis on the 400 accounts caring for one-half of all patients. Based on the clinical profile of XPOVIO and its oral administration of delivery, we expect that XPOVIO will be prescribed by both myeloma treaters at large academic institutions as well as at community-based oncology practices. We are fortunate to have a deeply experienced commercial organization.
In particular, our field force members have an average of 20 years of pharmaceutical experience, including an average of 12 years in the hematology/oncology space and five years specifically selling other multiple myeloma drugs. Additionally, we have a highly experienced account management team that has already begun to engage with the payer community to help ensure patients have access to XPOVIO. We have implemented an extensive patient and physician support program that I will highlight on the next slide. We have implemented a comprehensive program to support patients, their caregivers, and healthcare providers, we have named it KaryForward. The KaryForward program services will include the following: patient and caregiver-focused content and support, benefits investigation, reimbursement support, side effect management tools, and access to nurses at the patient support center on the phone who will be available to answer questions regarding expectations with XPOVIO treatment.
Additionally, we have decided to establish a focused distribution network of three highly experienced oncology specialty pharmacy providers to exclusively support patients who are prescribed XPOVIO. These three providers have extensive experience with specialized oncology medicines and will provide additional support to patients who are prescribed XPOVIO. In summary, we are confident that we have put all the right people, strategies, and initiatives in place to effectively support the commercial launch of XPOVIO. I'd now like to hand the call back over to Michael, who will provide some final thoughts. Michael?
Thank you, Perry. Let me also acknowledge what a terrific job that you and the commercial team have done in helping Karyopharm prepare for its first product launch in the United States. I look forward to watching you and your team implement the critical strategic comparative just outlined. I'd also like to acknowledge Anand Varadan , our Chief Commercial Officer, who has played an integral role in our commercial preparedness. Anand will be leaving Karyopharm, and we wish him well in his future endeavors and are appreciative of his contributions over the last year. While today's approval announcement, of course, a landmark moment for Karyopharm and for patients battling highly refractory multiple myeloma, I would like to briefly highlight some additional upcoming milestones for XPOVIO.
Later this year and into the first half of next year, we expect some additional important events, including a regulatory decision in Europe for the potential XPOVIO conditional approval in heavily pretreated myeloma patients by year's end. The top-line data from the BOSTON study, which if positive, would lead to an additional regulatory filing next year in earlier line multiple myeloma. The timing of the BOSTON data depends on progression events that could come by year's end or early next year. The planned submissions in the United States and Europe requesting accelerated and conditional approval in diffuse large B-cell lymphoma based on the data generated from the phase II-B SADAL study.
As we look out into the second half of 2020 and beyond, we expect phase III data from XPOVIO in liposarcoma and endometrial cancer, as well as additional geographic regulatory filings and commercial launches in multiple myeloma and DLBCL following these potential regulatory approvals. Let me provide a quick summary of today's call before we open things up for your questions. Since Dr. Sharon Shacham began her quest to discover and develop novel nuclear transport modulators at Karyopharm a decade ago, our team has taken a highly innovative idea through development and an initial regulatory approval with courage, urgency, resilience, and energy, exemplifying some of the best scientific and medical leadership in the biopharmaceutical industry. The FDA's accelerated approval of XPOVIO marks the first nuclear export inhibitor and the only medicine approved for patients whose disease is refractory to all five of the most commonly used anti-myeloma drugs.
We expect commercial product to be available on or before July 10th, 2019. Our field force and patient physician support initiatives are already in place to immediately support the commercial launch. Key product features of XPOVIO include a novel mechanism of action, single-agent activity in combination with low-dose dexamethasone, predictable and manageable tolerability profile without significant major organ toxicities and no black box warnings, and oral administration with convenient dosing. Finally, I'd like to close my formal remarks by offering my very sincere appreciation to all the patients, their families, physicians, caregivers, advocacy organizations, Karyopharm employees, the FDA, and investors in our company who have helped to get us to this monumental day. There's no way we could have gotten here without all of your dedication and persistence and your support, and for that, we are immensely thankful.
With that, I'd like to turn the call back over to the operator so we can answer some of your questions. Operator?
Ladies and gentlemen, if you have a question at this time, please press star, then the number one key on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. To prevent any background noise, we ask that you please place your line on mute once your question has been stated. Our first question comes on the line of Brian Abrahams from RBC Capital Markets. You may begin.
Hi there. Thanks very much for taking my questions and congratulations on the approval. First question from me, I was wondering if you had any clarity from the agency as to what's going to be required from the BOSTON study in order to maintain XPOVIO on the market, and then I had a couple of follow-ups.
This is the same situation as the many other accelerated approvals in multiple myeloma that they expect to see the data. As mentioned at ODAC, we hopefully will have a positive effect on the primary endpoint, which is the progression-free survival endpoint. Assuming that all works out, that'll maintain XPOVIO and also allow it to be moved up into second line or later therapy.
Got it. We know the PDUFA was obviously pushed out a bit in order for the agency to consider new data. Can you talk a little bit about what was shared with respect to some of the ongoing and previous studies with the FDA on safety and efficacy that swayed them to make the approval decision despite the mixed adcom?
First of all, it's important to remember that they not only look at the total vote on the adcom, but also the quantitative and content of each of the voters and they consider the backgrounds of the different physicians involved on ODAC and the other representatives on ODAC. That's point one. Point two is, I'd refer you to the FDA press release describing the approval of XPOVIO. They did provide a bit more insight into that than they've asked us to provide. If I can briefly, if you give me one second, I will quote from the FDA that, as they mentioned, "The efficacy evaluation was supported by additional information from an ongoing randomized trial in patients with multiple myeloma." Without being cute, the only ongoing randomized trial in multiple myeloma that we have now is BOSTON.
They did, as we mentioned publicly, they did look at some of the DSMB results, that helped with their thinking.
Very helpful. Last one from me. What impact does this have on your plans to file now in DLBCL for accelerated approval, the strategy and timing there? I'm curious, was there any reference to that indication during your discussions that might give you confidence in pursuing a path there as well? I'll hop back in the queue. Thanks.
Yeah. On the DLBCL, as we mentioned, obviously any approval gives FDA certainly more insight into the drug. We'll be looking to file that end of year or the beginning of next year, pending further discussions with the agency.
Thanks, Michael, congratulations to you and the team.
Thank you very much.
Our next question comes the line of Maury Raycroft from Jefferies. You may begin.
Hi, everyone. I'd like to add my congrats as well, and thanks for taking my questions. I was just wondering, based on the market research that you did and based on your understanding of how selinexor works from the STORM study and the other ongoing studies, do you have a sense of whether doctors will add sel plus dex on top of that fourth line of treatment, or will the patient have to completely wash out before selinexor are added?
Yeah. We can only comment on the actual labeled indication for selinexor dexamethasone in the lines. How doctors choose to treat patients is between them and the patients.
Very good. Just to clarify on the data from BOSTON that was submitted to the FDA for review, so you mentioned that they looked at information from the DSMB review. Can you comment at all on the level of efficacy data that was included in that?
We cannot. We're not privy to those data. That was a third-party discussion.
Okay. Very good. Congrats again, and I'll hop back in the queue. Thanks.
Our next question comes from the line of Jonathan Chang from SVB Leerink. You may begin.
Hi. Congrats on the approval, and thanks for taking my questions. First question, just to follow up on the previous question, can you clarify how the BOSTON readout could impact today's approval, I guess, as it pertains to both efficacy and safety data?
The guidance around accelerated approval, which is also listed in the package insert, and it's true for all accelerated approvals, is that this indication that was granted on accelerated approval may be contingent upon further verification in confirmatory trials, and that's basically what we can say.
Okay. Got it. Second question, in the past, you've spoken about the potential advantages of selinexor being an oral drug and how this could have an advantage in the community setting. What are your latest thoughts on this, I guess, especially with the additional detail you provided today on physician education and monitoring of adverse events?
Yeah, I'll start, and I'll turn it over to Perry. The team has come up with a comprehensive set of supportive care, which will be used extensively and offered to any patient who's receiving selinexor and any doctor that's considering treatment with it. We feel very comfortable that we are able to provide the most up-to-date and optimal care that we have found is available based on existing clinical trials. Perry, can you comment additionally on the oral and the supportive care?
Sure. We do have a full team of nurse liaisons who will be working very closely with accounts, whether it's a large academic institution or a smaller community-based practice, on the proper ways to help manage patients through any side effects that they may see. The general nature of the patient being later stage, a lot of those patients choose to take therapy at home, and even some of your rural community places, that's a distinct advantage for an oral medication. There's definitely flexibility for both large academic institutions and the community-based practices.
Got it. Thank you. Congrats again.
Thank you.
Our next question comes from the line of Arlinda Lee from Canaccord. You may begin.
Hi, guys. Congratulations. I had a few questions.
Thank you.
Thanks.
First, could you clarify, Michael, on the additional information that FDA considered from BOSTON, did that include both safety and efficacy? Maybe Perry, on dose interruptions, you've provided a lot of information on dose interruptions to help prevent discontinuation. How long were these patients interrupted for? Lastly, on the AE monitoring in the label, how different is that from what you did in clinical trials and community practice, and what you think might be the standard in community practice? Thanks.
Okay. It's a lot of stuff. I'll start with the first one. Very simply, as we discussed at the time, we had a DSMB evaluation. It included safety and efficacy. This was done through a third party, as is typical in these kinds of randomized studies, and we're not privy to that information. It was shared with the agency, we assume it included both safety and efficacy. On the second issue, we can say that the majority of the interruptions would be for less than two weeks, many of them would be in sometimes only one week of interruption. This was all learning that was done, all that learning we've included now in our materials going forward. I'll switch it over now to Perry and talk a little bit about the education.
Yeah. If you think about the patients that were included in the STORM trial, these are heavily pretreated patients, there's a lot of comorbid conditions that they come on with, it does require a certain level of oversight. I think that that's where, again, our team of nurse liaisons is going to be very helpful towards educating the accounts on the right ways to manage these patients, the right supportive care, and also through dose modifications. We believe that it's extremely important this late in therapy to try and keep patients on. It does require some navigation.
Thank you. As a reminder, that's star one for questions, star one. Our next question comes from the line of Ed White from H.C. Wainwright. You may begin.
Congratulations, guys. It's actually Ed White. I think all my questions on the launch were answered. Maybe you can just give us an update on Europe. We know that the regulatory decision in Europe is expected late this year. Maybe you can tell us a bit about the strategy there and potential partnering. Thanks.
Certainly. Simply put, as mentioned, the decision should be on regulatory in Europe for a conditional approval towards the end of the year. We are exploring two separate options there. One is a partnership with a focus in Europe, the other one is for us to go it alone, that go it alone strategy would be more of a focus strategy on a country-by-country basis, focused on those countries where discussions with regulators and reimbursement can be obtained more rapidly, then delaying, depending on which the country is, based on their timing for approvals and reimbursement. Those are the simple forks in the road, if you will.
Do you know when you're going to make that decision, whether to partner or go it alone? Would that be at the time of approval, or would you be able to give us some guidance on that before approval?
We'll make that decision when it's appropriate, pending discussions and explorations of both of those avenues in more detail. We have a lot of ongoing discussions now. That's all I'm prepared to say.
Okay, great. Thanks, Michael, and congratulations again.
Thank you very much.
Our next question comes from the line of Mike Ulz from Baird. You may begin.
Great. Hey, guys. Thanks for taking the question, and congratulations on the approval as well. Just had a question on diffuse large B-cell lymphoma. I think you mentioned potential filing sort of year-end or early next year. I'm just curious, now that you've got clarity on multiple myeloma, is there potential to accelerate those filings, or is it more to focus on the launch and then sort of worry about filing then?
We'll keep you posted on things. As you know, the final data from the study were presented in an oral presentation at ICML, and we'll keep you posted on our timeline.
Got it. Great. Congrats again. Thanks.
Thank you.
Thank you. Our next question comes from the line of Eric Joseph from JPMorgan. You may begin.
Hey, guys. Congrats on the approval, thanks for taking the questions. My first is on, I guess, with the language in the label being fairly explicit in being indicated for a penta-refractory patient population. I'm just curious to know from your discussions with payers whether they make a clear distinction between penta-refractoriness versus triple-class refractoriness. I guess, how heavily managed do you expect reimbursement to be to the label specifically? I guess just thinking about launch readiness, how should we be thinking about some of the breadth of payer coverage coming out of the gate and whether there's any sort of latency between now and your target broad coverage and access? Thanks.
Sure. I'll take the first one and turn it over to Perry on the reimbursement. Let's make sure we don't overread the label. The label is very explicit that says that the disease has to be refractory to two proteasome inhibitors, two IMiDs, and one CD38 monoclonal. It doesn't specify what those proteasome inhibitors should be, nor does it say what IMiDs it should be. We should keep that in mind. In the past, in general, physicians describe whether the patient's disease is refractory to something, and that generally suffices, and we would anticipate based on past behavior with other myeloma drugs, that could be in effect here, but we're not certain. Let me turn it over to Perry now on the reimbursement.
Yeah, sure. I think just due to the expected survival if these patients aren't treated, being three to five months and the unmet need there, we don't really anticipate significant access barriers from the payers. Additionally, we've begun discussions with payers and plan to actively work with the payer community post-approval to educate them on our approved label. We've put programs in place to help overcome any initial barriers to coverage, which we don't anticipate there would be a lot. We also plan to submit our clinical data to the National Comprehensive Cancer Network, the NCCN, for their guidelines, which we also believe would help support patient access from payers. We also established our commercial leadership team early last year in 2018, we hired our field-based sales and market access teams earlier this year.
Our team's well prepared to engage and support the payer community now that we have been approved by the FDA. We believe that we're going to be in really good shape.
Great. Thanks for the questions. That's helpful.
Thank you. I'm showing no further questions at this time. I'd like to turn the call back to Michael Kauffman for closing remarks.
Just to thank everybody very much again for joining us post-market today, I wish you a very happy Independence Day. Enjoy. Bye-bye.
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. You may all disconnect. Everyone have a great day.