Good morning. My name is Skyler, and I will be your conference operator today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics second quarter 2019 financial results conference call. There will be a question and answer session to follow. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Mr. Ian Karp, Karyopharm's Vice President, Investor and Public Relations.
Thank you, Skyler. Thank you all for joining us on today's conference call to discuss Karyopharm's second quarter 2019 financial results and business update. This is Ian Karp. I'm joined today by Dr. Michael Kauffman, our Chief Executive Officer, Mr. Perry Monaco, Senior Vice President of Sales, Mr. Mike Mason, Chief Financial Officer, and Mr. Christopher Primiano, Chief Business Officer and General Counsel. On the call today, we'll provide an overview of key recent corporate developments, including an update on the initial commercial launch of XPOVIO, as well as an overview of the second quarter 2019 financial results. Dr. Kauffman will discuss our upcoming milestones and provide some summary remarks before we move into the Q&A portion of the call. Earlier this morning, we issued a press release detailing Karyopharm's results for the second quarter. This release is available 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 provisions under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical development, and regulatory matters and timelines, the potential success of our product candidates, financial projections, and 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 annual report on Form 10-K, which is on file with the SEC, and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only.
While we may like to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. In addition, please note that references we make to clinical trial data during today's discussion refer to interim, unaudited site data unless otherwise specified. I'll now turn the call over to Dr. Michael Kauffman, Chief Executive Officer.
Thank you, Ian, and good morning, everyone. It's been a remarkable year so far for Karyopharm, which of course was accentuated by the recent accelerated approval of oral XPOVIO, also known as selinexor, by the U.S. Food and Drug Administration. XPOVIO is a first-in-class nuclear export inhibitor that was approved in combination with dexamethasone for the treatment of adult patients with relapsed or refractory myeloma, whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. XPOVIO is the first and only prescription medicine approved in the U.S. for this indication, and it is the first approved cancer drug that targets nuclear export dysregulation, which is increasingly recognized as a fundamental mechanism in the generation of malignant cells.
Importantly, because multiple myeloma is an incurable disease, an increasing number of patients will need new therapeutic options once their disease has become refractory to the currently available standards of care. Oral XPOVIO represents an entirely new mechanism of action and a novel approach in the treatment of multiple myeloma. Our commercial colleagues have been doing a tremendous job educating the myeloma community about this new treatment option, and I'll now ask Perry Monaco, our senior vice president of sales, to provide a brief update on how the commercial launch is progressing so far in just the first month or so post-approval. Perry?
Absolutely, Michael. I'm excited to provide some early commentary. Thanks to the hard work and dedication of the Karyopharm team, XPOVIO became commercially available in the U.S. on July 9th, 2019, less than one week after its official FDA approval. We have deployed more than 70 sales representatives and nurse liaisons who are focusing on the 1,300 accounts who treat roughly 80% of all multiple myeloma patients. Not surprisingly, we are placing additional emphasis on those 400 higher volume accounts caring for roughly one half of all patients. These commercial efforts are also being supported by our comprehensive, fully integrated KaryForward support program for patients, their caregivers, and healthcare providers. The KaryForward program provides support services such as insurance benefits investigation, side effect management tools, and nursing support. Additionally, our focused network of three highly experienced specialty pharmacy providers are providing additional support to patients being prescribed XPOVIO.
Finally, we are pleased that so many patient advocacy organizations throughout the U.S. are excited about the approval and are also educating the myeloma community about new treatment options. We thank them for all they do for patients and their families, and we remain committed to supporting patients and the myeloma community. While we are in the very early days post FDA approval, the commercial launch thus far is off to a strong start. Early prescribing trends have been encouraging, with robust demand from both academic and community-based physicians throughout the U.S. Additionally, we are seeing early prescriptions being filled for patients with Medicare, as well as for those with commercial insurance coverage. We are also already seeing encouraging progress within the payer environment, as many payers clearly appreciate the urgency in which patients with heavily pretreated myeloma need new treatment options.
XPOVIO is already being covered by some of the largest national payers and has been quickly added to some key formularies, including that of Express Scripts, one of the largest PBMs in the U.S. We look forward to providing more details regarding the ongoing launch at our third-quarter earnings call in November, when we will report on nearly a full quarter of XPOVIO sales. So far, the early feedback from healthcare providers has been positive, and we remain optimistic in our ability to effectively bring this important new medicine to patients in need of novel treatment options. I'll now turn the call back over to Michael.
Thank you, Perry. Beyond this very important first accelerated approval, we continue to focus our efforts on gaining regulatory approval for XPOVIO beyond the U.S. market, as well as expanding the breadth and depth of approved indications for selinexor. To that end, we fully enrolled the pivotal phase III BOSTON study in January. BOSTON is evaluating selinexor in combination with VELCADE and dexamethasone, compared to VELCADE and dexamethasone alone in patients with myeloma who have 1 to 3 prior lines of therapy. As we have highlighted previously, the Data Safety Monitoring Board for BOSTON convened earlier this year and determined that first, on the safety side, no new safety signals have been identified on the study and that there was no imbalance in mortality in the two arms of the study.
Second, on the efficacy side, based on the first interim analysis, the board recommended proceeding with the study as originally planned, with no changes in patient numbers. Progression-free survival is the BOSTON primary endpoint, and we remain on track to have the top-line results from this study by the end of 2019 or early into 2020, depending on the occurrence of progression events. In parallel with the U.S. activities, we are also working with the European Medicines Agency on a Marketing Authorisation Application, or MAA, requesting additional conditional approval for selinexor in combination with dexamethasone based on the clinical data from the STORM study, which served as the basis for XPOVIO's U.S. accelerated approval. We expect to receive a decision on this application by the end of 2019 or early 2020.
In addition to the BOSTON study, we are also investigating selinexor in combination with other standard of care myeloma drugs as a potential new backbone therapy in patients with earlier-line myeloma. Three abstracts highlighting new and updated clinical data from the KYPROLIS, DARZALEX, and POMALYST arms of the phase I-B/II STOMP study were presented in June at the European Hematology Association 2019 annual meeting. We continue to be encouraged by this combination data, as we believe the full commercial and therapeutic potential for XPOVIO in multiple myeloma will be as part of combination regimens, subject of course, to additional future clinical trials, regulatory filings, and approvals. Turning now to our other selinexor development programs beyond myeloma.
For diffuse large B-cell lymphoma, following the presentation of updated positive data from the phase II-B SADAL study presented in June at the 2019 International Conference on Malignant Lymphoma, we are now working towards NDA and MAA submissions requiring accelerated and conditional approvals respectively for patients with relapsed or refractory DLBCL who have received at least two prior multi-agent therapies and who are ineligible for stem cell transplantation, including CAR T therapies. We expect to submit the NDA and MAA packages between the fourth quarter of 2019 and the first quarter of 2020. We anticipate some further clarity on timing and any feedback from a pre-NDA meeting we expect to schedule with the FDA in the fourth quarter of this year.
For the ongoing phase III portion of the phase II/III SEAL study, where selinexor is being investigated as a single agent versus placebo in liposarcoma, enrollment continues on track. Assuming a positive outcome on the primary endpoint of PFS, we intend to use the data from the SEAL study to support NDA and MAA submissions requesting approval for selinexor for the treatment of advanced unresectable dedifferentiated liposarcoma. Top-line data from the phase III portion of the SEAL study are anticipated in 2020. Finally, we were excited to present updated efficacy and safety data from the phase II KING study evaluating single-agent selinexor in patients with recurrent glioblastoma, which was recently highlighted at the American Society of Clinical Oncology, ASCO, 2019 annual meeting.
Of the 30 patients treated in the 80 mg dosing cohort, the overall response rate was 10%, with 19% of patients achieving a six-month PFS rate and 38% of patients achieving a six-cycle PFS rate. The most common treatment-related adverse events were cytopenias, along with gastrointestinal, constitutional symptoms, and were primarily Grade 1 and 2 events. Based on these data, we have recently entered into an exciting new collaboration with the Ivy Brain Tumor Center at the Barrow Neurological Institute to conduct preclinical testing of several new drug combinations involving selinexor for the treatment of glioblastoma. If the preclinical work proves successful, viable selinexor combinations will advance into Ivy's unique tissue-based phase 0 clinical trial format, which enables researchers to understand if an experimental therapy is impacting an individual patient's brain tumor in as little as seven days, saving critical time in this highly aggressive form of brain cancer.
Before I turn the call over to Mike to discuss the financials, I'd also like to take a moment to mention that our founder, president, and chief scientific officer, Dr. Sharon Shacham, recently received the esteemed New York Intellectual Property Law Association 2019 Inventor of the Year award. This award recognizes Dr. Shacham for her important research that led to a better understanding of nuclear transport abnormalities in cancer and her cutting-edge work designing and developing oral selinexor, as well as several other of our pipeline assets. Past winners of this award have included the inventors of CAR T therapy, Gleevec, Valium, and LASIK laser vision correction, amongst many others. Of course, her work was the foundation for the accelerated approval of XPOVIO received last month. We offer our sincere congratulations to Dr. Shacham and the entire development team for winning this prestigious award.
With that, I will now turn the call over to Mike.
Thank you, Michael. Since we issued a press release earlier today with the full financial results, I will just focus on the highlights. As of June 30th, 2019, cash equivalents, and investments including restricted cash totaled $217.9 million compared to $330.9 million as of December 31st, 2018. As XPOVIO was approved on July 3rd, 2019, we will begin booking product revenues in the third quarter of 2019. For the second quarter of 2019, license and other revenue was $9.5 million compared to $19.9 million for the second quarter of 2018, primarily related to the company's license agreements with Antengene and Ono, respectively. For the second quarter of 2019, R&D expense was $26.5 million compared to $44.7 million for the second quarter of 2018. We expect R&D expense on a quarterly basis to be relatively consistent for the remainder of 2019 compared to the second quarter of 2019.
General and administrative expense for the second quarter of 2019 was $24.7 million compared to $9.5 million for the second quarter of 2018. The increase in G&A expenses compared to the prior year period was due primarily to the hiring of the Karyopharm commercial team and related commercial launch preparation activities to support the U.S. commercial launch of XPOVIO. We expect G&A expenses for the remainder of 2019 on a quarterly basis to be relatively consistent with Q2 2019. For the second quarter of 2019, we reported a net loss of $43.4 million or $0.71 per share compared to a net loss of $33.7 million or $0.60 per share for the second quarter of 2018. Net loss includes stock-based compensation expense of $4.1 million and $4.4 million for the second quarters of 2019 and 2018, respectively.
Based on our current operating plans, we continue to expect our full year 2019 operating expense to be between $200 million and $215 million, excluding stock-based compensation. We expect that our existing cash equivalents, and investments will be sufficient to fund operations in the second half of 2020. I'll now turn the call back over to Michael for concluding remarks. Michael?
Thank you, Mike. Before moving to the Q&A, I'd like to provide a quick overview of our key upcoming milestones. First, we will execute upon our commercial launch initiatives as we have just begun to see the initial impact XPOVIO can have in the marketplace, and more importantly, on expanding the treatment options for patients battling multiple myeloma. We continue to work closely with the EMA in support of our MAA requesting conditional approval for selinexor, and we expect to receive a decision by the end of 2019 or early 2020. For our next potential indication in relapsed or refractory DLBCL, we plan to submit an NDA to the FDA with a request for accelerated approval based on the SADAL trial results sometime between the fourth quarter of 2019 and the first quarter of 2020. We expect greater clarity on timelines following a pre-NDA meeting with the FDA.
We also plan to submit an MAA in Europe with request for conditional approval in the same time frame. For the pivotal phase III BOSTON study, enrollment was completed in January, and top-line data are expected by the end of 2019 or early 2020, depending on the occurrence of progression events in the trial. If positive, these data could support regulatory submissions in 2020 in second-line myeloma. Next, the various arms of the phase I-B/II STOMP study continue in myeloma, and we look forward to presenting updates from the various combination arms at future medical meetings. Finally, we will continue to progress our solid tumor programs in liposarcoma and endometrial cancer. In summary, 2019 is shaping up to be a truly exciting and transformational year for Karyopharm and for patients battling multiple myeloma as we work to drive awareness and adoption of our first marketed product, XPOVIO.
We are also working in parallel to expand upon selinexor's clinical and commercial potential in new territories and clinical settings where there are patients with high medical need. We appreciate all of your support, and we look forward to keeping you updated on progress in the coming months and quarters. I'll now turn the call over to the operator for questions. Operator?
Ladies and gentlemen, if you have a question at this time, please press the star, then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Our first question comes from Maury Raycroft with Jefferies. Your line is now open.
Hi, this is Mitchell on for Maury. Thank you for taking our questions. My first question is, can you remind us what were the pre-specified criteria for determining whether to upsize the BOSTON study or not?
No, I can't. Not to be cynical, I can't remind you because we didn't announce this. The trial is designed to show approximately a 30% reduction in the risk of progression or death against the control arm. You can imagine with a hazard ratio of about 0.7, if we were far off from that, this trial would've been stopped for futility. If we were close to that but not in that zone, we would have upsized the trial. We did neither, you can assume that we were in the range.
Okay, thanks. What more can you say about the prescribing trends you're seeing? Are you seeing docs combine XPOVIO with other myeloma drugs? Can you talk about the types of patients that you're treating?
It's still too early to really see trends in terms of how they're exactly using the drug. What I can tell you is that we've seen some encouraging demand from all parts of the country, and we're seeing demand come from both community and academic institutions. Again, we're still in the first month, so it's really hard to really see what kind of trends it looks like in terms of each individual prescription that's coming through.
Okay. Maybe my last one. Could you talk a little bit about the KaryForward program and how involved the support program gets?
The KaryForward program is a very comprehensive program that provides nursing services to patients, to help with getting them through if they're experiencing any side effects. They will also put patients on our QuickStart program. We understand that the dynamic of the patient that's receiving XPOVIO a lot of times is they're out of treatment options. A lot of times patients can't wait for insurance verifications, so they will put them on a QuickStart in order to get drug into a patient quickly, and then they're transferred over, generally to our specialty pharmacies. They will also provide support to caregivers and family members to help support the patient through their treatment.
Okay, great. Thanks.
Next question.
Thanks.
Our next question comes from Brian Abrahams with RBC Capital Markets. Your line is now open.
Hi. Thank you for taking my questions. Congrats on the XPOVIO launch and congratulations to Sharon for the award. I want to drill down a little bit more on the launch dynamics. I guess I'm curious how the openness for, and maybe capabilities, for safety management, how that's been overall, maybe how that's differed perhaps between academic versus community sites and the ways in which this management is being accomplished, either through supportive therapies, dose reduction, interruptions, et cetera. I had a follow-up. Thanks.
Yeah, I'll start and then I'll turn it over to Perry. The label for XPOVIO was fairly general and often included words like, use instituted standards supportive care, which gave us some leeway. In addition for the typical side effects of XPOVIO, which as you know are nausea, anorexia, and fatigue, and low platelets, there are very standard protocols out there with a number of drugs and often NCCN guidelines that can handle this. Sites have been very open to us relaying all of the knowledge that we gained during the clinical trials, and I think doctors are very willing to use the best practices that so far have been determined for all of this. There's been really a great openness, I think, for standard supportive care, and prophylactics as well. Perry, do you want to add?
I don't have a lot to add to that other than that our supportive care guidelines and our dose modification criteria are clearly laid out in our label, and our reps are trained to do that. On top of that, a very critical piece is our team of Karyopharm nurse liaisons. They are working with practices to provide additional education on managing patients with XPOVIO. As mentioned earlier, our KaryForward program is a comprehensive support program for both the physicians and the patients. We also have our network of highly specialized pharmacies, and they provide some of those same services as well. What we're trying to do is we're trying to wrap that patient with the right amount of care in order for them to have a good experience with XPOVIO.
That's really helpful. Thank you. Then you've talked about the first interim analysis for BOSTON. I'm also wondering what level of real-time safety or mortality data might you and the FDA have coming out of the BOSTON study, and whether this might give you any additional insights or confidence as far as the safety or efficacy of selinexor in the earlier line population. Thanks.
Yeah. On safety, as sponsoring medical monitors for the study, we have a very good view of ongoing safety adverse events and any fatalities that are on study and even after patients leave the study. Sitting here today, we feel as confident as we did six months ago, saying that there is no imbalance in deaths on either arm of the study, and we are privy to these in real time. For adverse events, again, we've not seen any new adverse events. On the efficacy side, we do not see compiled or rolled-up information on efficacy, so we can't speak to that. Of course, it's a phase III study, so we wouldn't.
Thanks again, and congrats again on all the progress.
Thank you very much.
Our next question comes from Eric Joseph with JP Morgan. Your line is now open.
Hey, good morning, everyone. This is Turner on for Eric. Just looking ahead to the BOSTON data, I'd like to get a sense of your expectations for the proportion of patients having prior DARZALEX or anti-CD38 treatment. Was this a stratification factor within the study design? Is there the potential for that level of granularity in the readout?
Yeah. We don't have rolled up demographic data at this point, and we'll have to wait for a medical meeting to announce that. I will say that there is no stratification for prior CD38 because it's not known to be a major component of a response or not to selinexor-dexamethasone or to Velcade-dexamethasone itself. That'll have to await an analysis. I should also point out that the trial is being conducted in U.S., Canada, and Europe, as well as Australia and India. Therefore, the use of DARZALEX is not quite as prevalent as in the U.S., so we don't expect it to be a major component of people's prior therapies in BOSTON.
Okay. On selinexor and DLBCL, is the current expectation that a confirmatory study would be required for full approval? If so, how should we think about the design of that trial and any timeline?
Yeah. As with all accelerated approvals, there will be a commitment, which we hope to be a post-marketing commitment, for a confirmatory randomized trial. The design of that trial is being investigated now. In general, you should think of it as a chemotherapy-type backbone or a novel accepted therapy-type backbone, plus or minus selinexor. That'll be a randomized study, most likely in patients with at least one prior therapy.
Okay, great. That's helpful. Just one last quick one from me, in solid tumors in the ongoing phase III SEAL study in liposarcoma, I'm just wondering if we can expect any interim analyses to be performed. Thanks.
Yeah, as soon as we have any major endpoints from the SEAL study, we'll be happy to disclose them, but I'm not going to discuss any more details at this point.
Great. Thank you.
Again, if you have a question, please press star and then one. Our next question comes from Arlinda Lee with Canaccord. Your line is now open.
Great. Thanks very much for taking my questions. I had a couple on if you could provide some color on discussion with payers and what we might hear about in the update from the next call. Secondly, you've talked about education to help ameliorate severity or duration of AEs. Can you talk about how KaryForward might be helping with that? Thirdly, on BOSTON, what is the dose modification scheme in BOSTON versus your current label, and what's allowed for bortezomib dose changes as well? Thank you.
All right. I'll start. With regards to payers, so far the response from the payers has generally been positive, and we're not encountering significant roadblocks. Of course, it's still early in the launch cycle, but our sense is that the payers understand the urgency in which the indicated population for XPOVIO need new treatment options. We're already seeing prescriptions generated and subsequently approved from both large commercial payers and Medicare Part D plans. As I mentioned earlier, XPOVIO has already been added to a number of payer formularies, including Express Scripts, being one of the nation's largest PBMs. In terms of AE management and how the KaryForward program works with that, what the KaryForward team of nurses will typically do is they will set up a series of calls with patients based upon patient need and their desire for those services.
They will check in with them, find out how they're doing. If the patient reports having some AEs, KaryForward will then report back to their healthcare provider so that they can make any adjustments to supportive care or anything like that that a patient might need. Michael, you have anything that you want to add, or?
No, nothing.
As far as BOSTON is concerned, well, the current dosing reduction scheme is actually very simple for the indications for the STORM patients, that's starting at 80 milligrams twice a week with low-dose dexamethasone. The first dose reduction moves to 100 milligrams once a week, 80 milligrams once a week, 60 milligrams once a week. The BOSTON dosing regimen starts at 100 milligrams once a week with selinexor, moves down to 80 and 60, the lowest dose on BOSTON is 40, which we do believe does confer some synergy with the Velcade. Velcade dosing is standard for the control arm, that's 1.3 mg per meter squared twice a week, given subcutaneously, two out of every three weeks for the first eight cycles, it moves into the more maintenance regimen.
On the selinexor arm, importantly, Velcade begins at once weekly, and this is a fundamental difference between BOSTON and most of the other phase III studies that have been done with Velcade. The real-world use of Velcade is once weekly in most cases, and we're instituting that from the get-go with selinexor. It's selinexor once a week at 1.3 mg per meter squared of Velcade, and then dose reductions for Velcade are always 1.3 down to 1.0, then to 0.7, which is standard.
Thank you.
Thank you.
Our next question comes from Jonathan Chang with SVB Leerink. Your line is now open.
Hi, guys. Thanks for taking my questions. First question, regarding the early launch, any color on physician feedback and any similarities and differences between academic and community-based physicians?
It's still too early to say whether there's any significant difference between academic and community-based physicians. The general feedback is that things are going well, and we're getting results that we would have expected.
Got it. Can you talk about the implications of the BOSTON readout on the path forward in DLBCL?
Well, obviously these are different diseases. FDA is always looking for randomized data. We will be meeting with the FDA in a pre-NDA meeting to specify the exact timing of the DLBCL submission. The data are complete. We're cleaning them and preparing the NDA. We don't see a major interaction between those two studies. If the FDA would like to see data from BOSTON as they did for the STORM review, we of course, would provide it.
Got it. Just last question, any updated thoughts on how you're thinking about business development opportunities for selinexor?
Sure. Yeah. Hi, this is Chris Primiano. Obviously we intend to maintain commercial rights in the U.S., the question is how do you handle Europe? There are a couple of different options that we have that we're continuing to assess. One option could involve a partnership, we of course, would look for a partner that would have a mutually beneficial relationship with us and with the partner and maximize the potential of selinexor in the European market. It'd be really important that we find a partner that aligns with our philosophy regarding long-term development and commercialization plans and has the expertise in marketing in both heme and solid tumor drugs in the EU.
A second option would be to potentially launch selinexor on our own in select European countries where reimbursement negotiations and decisions typically occur more quickly and at acceptable levels. You sort of have this stepwise approach to expanding throughout Europe. Our view is that the value of selinexor will build over time as we progress through our discussions with FDA and EMA on the various different indications that we've been discussing. We'll be focused on making sure that we are achieving the best value of selinexor for the company.
Got it. Thank you.
Our next question comes from Mike Ahles with Baird. Your line is now open.
Hey, guys. Thanks for taking the question and congrats on the launch as well. Just a quick question on the European filing. Just wondering if you can comment on your interactions with the EMA and if there's been any noticeable differences compared to that with the FDA.
Look, the interactions with the EMA are intense. We received lists of questions as expected, the 90-day questions and so on. It's been a very scientific discussion back and forth. Very comprehensive set of questions spanning the entire development program and I would say it's similar to the FDA and perhaps in some areas, even more delving into details.
Got it. In your prepared remarks, you mentioned thinking about additional combinations with standard of care and beyond VELCADE, which you're using in BOSTON. Maybe if you can just give us your current thinking there, maybe timing of starting some of those studies, if there's a particular combo you're thinking to go with next after VELCADE. Thanks.
Sure. We haven't firmed up the next registrational studies in myeloma. Part of this is a larger, more comprehensive discussion about whether we expand broadly in myeloma, and/or expand into other different tumor types. As you know, one of the unique aspects of XPOVIO is that it's relevant to the generation of various types of malignancies, potentially any malignancy, and therefore can be used broadly. We're exploring liposarcoma, uterine cancer, and brain cancer as well as some of the hematologic malignancies. In terms of exact combinations in myeloma, the initial strategy is really to have the BOSTON data come in, hopefully positively. Then support that with NCCN guideline listings for the other various combinations that we're using. We're quite excited about all the different combinations, as highlighted recently at the EHA meeting, and we'll have additional highlights, I think, later this year.
The combination with DARZALEX is particularly exciting. This is a once-weekly regimen, as are all of our selinexor dosing regimens. The combination with KYPROLIS, although early, looks extremely promising and is consistent with the VELCADE data, and these are in more heavily pretreated patients than we would see with BOSTON. The all-oral combination with POMALYST, where we see approximately a doubling of the expected response rate for POMALYST itself and a much longer PFS than what you see with POMALYST itself, makes that all-oral regimen particularly intriguing. Finally, we intend to update on combination with REVLIMID later this year, as well as new mechanisms come into play, we'll expect to be a simple oral once-a-week partner for essentially any new mechanism. This is really a broad-based backbone type of therapy where we've seen additivity or synergy with essentially all the combinations.
Again, just to close, where we go in terms of approvals with the combinations, we have not decided yet. We will have guideline-based submissions.
Thank you.
Our next question comes from Ed White with H.C. Wainwright. Your line is now open.
Hi. Thanks for taking my question. All of my XPOVIO questions have been asked and answered already. Just wanted to ask about eltanexor, if you can just give us an update there and when we'll see the next expected data. Thanks.
Sure. We presented data in prostate cancer in combination with second-generation androgen inhibitors earlier this year, and we expect to expand on those data later this year or early next. Potentially, we'll be planning potentially an approval study for eltanexor, most likely in prostate, but we haven't decided exactly yet.
Okay. Thanks, Michael.
At this time, I'm showing no further questions. I'd like to turn the call back over to Michael Kauffman for any closing remarks.
Just to thank everybody for joining us, and we look forward to updating you on the launch, and the rest of our progress in the three months.
Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone have a great day.