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

Hi, everyone. My name is Maury Raycroft, and I'm one of the biotech analysts at Jefferies. It's with great pleasure that I'd like to welcome the Karyopharm team, including Richard Paulson, CEO; Mike Mason, CFO; and Jatin Shah, the CMO. Thanks for joining us today for our London conference.

Absolutely. Great to be here, Maury.

And we're going to do a fireside chat format. So maybe to start off, for those who may be new to the story, can you provide a 1-minute intro to Karyopharm?

Sure. I mean when you look at Karyopharm, we're still a young company. We are an innovation and science-based commercial-stage pharmaceutical company now that's pioneering novel cancer therapies to improve cancer patients' lives. And we are the first and only nuclear export inhibitor-based organization, and we attack a foundation of cancer. Many cancers inactivate the tumor suppressor proteins and we kind of reactivate the tumor suppressor proteins with XPOVIO, our lead compound. And we have the potential, through that, for activity across both hematological and solid tumor cancers. And currently, we already have 3 approved indications in the U.S. with multiple myeloma in the penta-refractory with relapse/refractory DLBCL and with multiple myeloma in the second line plus, which we're still very much in the early days of our second-line launch.

Very good. I think that's a good overview. And maybe if you can talk a little bit more about XPOVIO or selinexor, that drug and the key clinical data for the drug and when it got approved.

Yes. Our second-line approval happened in December of 2020, and the second line is XVd, which is almost at half the dose of our first approval, which we'll get to in a moment. But in our approval in December 2020 in the XVd once weekly, we have a high overall response rate of 76% with really deep and durable responses of XVd compared to Vd, a very manageable safety profile with no black box warnings or contraindications. And our initial approval in penta-refractory came back in July 2019. So for us, I think as we've evolved, we've been learning about the appropriate dosing and about the evolution and the impact that XPOVIO can have for patients. And we've evolved, as I said, from that first approval in the penta-refractory kind of twice-weekly 160 dose, now to weekly at 100 to 80 in the second-line plus setting.

Got it. And you've been commercial for a few quarters with the later-line setting and also with the earlier-line label expansion. And in your 3Q update, it seems like you're getting traction in the second-line to fourth-line multiple myeloma setting commercially. Can you talk about where you're at commercially and where you aim to go for the fourth quarter and 2022 in multiple myeloma?

Yes. So Maury, thanks for that. I mean, we've just come off a really strong quarter where we saw significant demand growth with 32% Q-over-Q revenue growth, really driven by, I think, strong execution and a new positioning that we put in place in Q2. And that positioning, I think, is really unique and it's in the white space in that second to fourth line. And as we put the positioning in place, we also made sure we had strong data to support that positioning, which we released through the second and third quarter at a number of different medical conferences. And with that positioning, we've seen the accelerated shift into earlier lines. Our syndicated data indicates our strongest growth is coming in the third line as we shift from the mentioned kind of doublet regimens to the once-weekly triplet regimens. And on top of kind of that third line focus we have, we're really expanding also the breadth and the depth of use. So we're adding more accounts every quarter and a continued double-digit growth in new accounts. But also in those really kind of top 25% of accounts, we're continuing to increase the penetration and getting prescribers to use XPOVIO for more patients in those big accounts. And so these efforts have kind of yielded us our strongest growth ever, which we're very proud of, and the team's working hard on. And that growth has come primarily through the community setting, where about 70% of the second to fourth line patients sit. So even though we're in the early stages of our launch still, I think continuing to drive strong growth that we're focused on, continuing to execute on our positioning and really driving the breadth and depth across those key accounts. So we're not going to give kind of a sequential guidance yet, but I think we remain confident in the ongoing efforts to drive the increasing use and we also see a number of our kind of qualitative market research surveys, positions becoming increasingly confident about utilizing XPOVIO in earlier lines.

Got it. And Richard, can you talk a little bit more -- I guess, you're probably not going to provide too many details by -- with the breadth and depth of the accounts, can you talk a little bit more about how you make progress on those fronts?

Yes. So I think when you look at the breadth and depth of the accounts, we continue to grow double digits in terms of adding new accounts. And then in the accounts that make up kind of the top 25% of accounts, which probably sit about 70% to 80% of the patients, really positions to be increasingly confident, as we said, in the earlier lines. So finding the real benefit of using, I think, a different kind of mechanistic approach. And so when you look at it, most patients are treated with an IMiD, a PI or an anti-CD38 in the first 2 lines. And in the later lines, there are several competitors or classes in that mix kind of in the fourth or fifth-line plus. But when you look in that middle section, kind of that second to fourth line, there's a strong rationale for a class switch and it's what physicians want to use, and it really extends the benefit the patients can get through the whole treatment pathway when they're managing their multiple myeloma, which is great for patients. So really, I think it's allowing us to improve outcomes. It's allowing us to make sure that patients and physicians have access to new innovative compounds. And as we drive that switch, I think we're seeing right now that about -- we're kind of approaching a 50-50 split. So about 50% of our business is coming from the triplets, about 50% is still in that later lines. So it still gives us good confidence around continuing to grow into the earlier lines. And right now, we see about 90% of our patients are actually on the 100 milligrams or lower dose. And so that dosing, as we said, has continued to evolve. And I think it's giving us very strong confidence in the future and continuing to grow in that second to fourth line.

Got it. That makes sense. And you also talked about this a little bit, too, with the recent growth from the community of physicians as well as growth from that third line setting specifically. Do you think those trends are going to hold up going forward? And what strategies are you implementing in order to maintain growth in these areas?

Yes. I think when you look at the -- as I said, our strongest growth has come in that community setting. So we're going to continue our focus. It's just head down execution. We need to be out there as we're all working through the COVID challenges that are still ebbing and flowing in different areas. So continuing to get out there, continuing to grow that confidence, continuing to execute. And as we do that, I think we're going to continue to see the movement into the earlier lines. I think as we know, moving forward, too, we're still going to see some impacts of COVID, which has some impact on patient flows, and that's kind of going to ebb and flow as we move forward. But I think we're looking forward to see strong continued growth as we move forward and continue to, I think, establish ourselves as a standard of care in that second and fourth-line setting.

Got it. Okay. And what commercial metrics in multiple myeloma should investors be focused on? And can you talk about commercial data that you get access to and what you're paying attention to?

Yes. I think on the commercial metrics side, there's a lot of different sources out there. I think you want to look at a couple of the key areas we've talked about. So you want to really look at what line of therapy we're being used in. So we've talked about that in terms of us moving up into the earlier lines. I think you also want to look again at how you're growing your breadth and your depth. So we talked about that in terms of continuing to grow new accounts, but also really making sure, in those larger accounts, you're driving that depth, which I think is really important. Another key metric is continuing to look at physicians' attitudes and their view on the confidence in your efficacy, which is critically important to confidence in managing the patients and their intent to prescribe. And so we look at that in terms of syndicated research. And then as we look also, it's important to look at the evolution of patients as you look at the duration of therapy for patients. In the earlier lines, we are seeing patients being on therapy longer, and I think that's important. There's a number of different sources for it and that data has to mature. So as you look at that, we're not giving guidance on different kinds of duration. I think it's really in the earlier lines, having patients on a longer duration of therapy is critical. And we've got to let that data mature as we move forward.

Got it. Okay. And can you talk about ongoing multiple myeloma studies or analyses that are underway and how these could fit into your plan to expand the opportunity or solidify positioning earlier line?

Yes, maybe I'll turn it to Jatin on that.

Yes. No, absolutely. So we have a couple of studies that are ongoing. I think that really sort of solidify that. And I think I'll highlight, too, specifically. One is the STOMP study which looks at various XPOVIO-based combination study, evaluating XPOVIO in combination with carfilzomib or pomalidomide or daratumumab, all of which is published in additional combinations. So that gives additional data for our physicians out there for combinations in earlier lines of therapy. The second -- and all of these have actually been really important because they've supported various Phase III trials or NCCN guidance. So for example, the combination of selinexor and pomalidomide from the STOMP study led to several ASH oral presentations and being listed on the NCCN guidelines. The combination of selinexor and daratumumab also from the STOMP study supported a listing on the NCCN guidelines as well. And so all of these have been very supportive. I would say the second study that's actually really important is the combination of selinexor, pomalidomide and dexamethasone versus elotuzumab, pomalidomide and dexamethasone. So that's a planned Phase III study evaluating the all-oral combination of selinexor, pom-dex that will be in patients. So essentially, we've had an IMiD, a PI and a CD38-based therapy, again, cementing our positioning post the CD38 based therapy, leveraging class switching, switching from a CD38-based therapy to an XPOVIO-based therapy and giving the optionality of PIs or IMiDs. So both of these studies have been critical both to really provide data post CD38 and really cement our positioning in that space.

Got it. That's really helpful. You were going to say something else, Jatin?

No, no, sorry.

And with all the data that you've shown, I think competitors are still moving forward in the space. How do you think about competition in myeloma?

Yes. I mean I think it's an area where there's a number of alternatives for physicians. I think there's a number of classes. And I think that's fantastic for patients, and we want to be able to continue improving outcomes for patients. So as competitors and new agents come to market, I think it's really important we look at the opportunities. Again, you really plan out sequencing. You plan out how to use all of the agents we have to the benefit of patients. And I think, again, that comes back to what Jatin was just talking about, the importance of the class switch, the importance of us being a novel class. And then the other agents that are coming to market and already are in market, I think physicians have that opportunity to really give patients a maximum kind of benefit that they should be getting in multiple myeloma as we all work to continue improving outcomes for patients.

Got it. And for the ASH data that you guys have coming up. We'll get back to that. But maybe before we get there, let's talk about SIENDO. You've got a Phase III readout that's going to be interesting for the space. Maybe if you can talk about that study for selinexor as maintenance therapy in endometrial cancer and briefly set the stage and talk about the market size, the unmet need in this indication and how selinexor can improve the standard of care.

Sure. And maybe I'll start and talk about the market a little bit, and then I'll turn to Jatin to talk to the study and go through our rationale for why we moved pretty rapidly into a Phase III trial, which is reading out shortly. So Maury, when you look at endometrial cancer, it's the most common gynecologic cancer in the U.S., over 65,000 cases. And within that, there's estimated to be -- I think it's about 14,000 advanced for metastatic cases that are treated with chemotherapy. And it's these patients, which we're focused on trying to provide benefit to. So about 70% of the patients who are treated with chemotherapy get a response. And it's this population that would be eligible for maintenance therapy. And what you want to do is you want to really sustain the response, you want to give them more time. You want to give them more time and sustain the response they achieve from chemotherapy. So it's patients who have responded and you want to give them time to keep their cancer from growing or returning. And right now, there's no approved drugs in this maintenance setting. So patients in endometrial setting who've gone through this chemotherapy treatment, they just watch and wait. They watch and wait for their cancer to come back. So I think it's an area with significant unmet need, where we can provide a real benefit to patients very rapidly, and it really supports, I think, a strong indication for XPOVIO pending successful clinical trials. And for the trial, I'll turn to Jatin for the trial and kind of why we're excited about it.

Yes, absolutely. Thanks so much, Richard. Absolutely. So I mean, I think the challenge is that in this setting, the standard of care is chemotherapy of Carbo/Taxol-based chemotherapy. Patients typically receive that to 4 to 6 cycles of therapy. And then, as Richard mentioned, going to kind of a careful observation, watch and wait, and they're typically in remission for several months, 4 to 6 months on average. And so really, there's a critical unmet need in this setting to extend this time and remission. And we know that's an important concept that's been well established in many other, both blood as well as solid tumors. And so when we look in the space, there's a clear opportunity and a clear need for oral therapy to prolong time and remission. And so as we look at why we're confident about moving into the space, we refer back to our initial Phase II trial looking at single-agent selinexor in patients with refractory endometrial cancer. When you look in that specific study, those patients who had a median of 3 lines of prior therapy had chemotherapy-refractory disease and growing disease, not in remission, but refractory disease that's progressive. In that setting, we're actually able to demonstrate that about 1/3 of patients had a disease control. That means either a complete remission or partial remission or stable disease for at least 3 months and that's important. Remember, these patients are actively progressing. So if we can temporize and stabilize their disease, that's clinically important. And for those 1/3 of patients in that late-line setting, their disease control duration was 6 months. So it was not a transient disease control that we had. It's a real clinical benefit for those patients. And that gave us confidence that single-agent selinexor in the third line in chemotherapy-refractory disease demonstrated clinical signals of activity. Now we pivot into, essentially, the SIENDO study, which is moving from third line to first line from chemotherapy-refractory to chemotherapy-sensitive disease. And finally, patients with disease that's in remission as opposed to patients with progressive disease with a high disease burden, these are patients after chemotherapy in a complete or partial remission. And so we translate that data, that we know it works in those late line settings, into the SIENDO study, where we think we can make a big difference. And that supports, really, the Phase III SIENDO study, which looks at patients after they've completed 4 -- 6 cycles of combination chemotherapy, which is the standard of care in the U.S.; and after they complete their chemotherapy, they're enrolled into the study and randomized either to selinexor or placebo and watch for progression-free survival. And so it's a 2:1 randomization, about 248 patients are planned to be enrolled in that study, and we expect top-line readout shortly. And enrollment is on track for that study.

Got it. Interesting. I think that's a great setup for the study and the design. And for that study, it's -- part of the goal is to achieve a 0.6 hazard ratio on PFS for selinexor as maintenance. And can you talk a little bit more about where you get confidence in that stringent HR bar? And I'm also wondering if there's a go-forward scenario where you can still move forward if you don't show exactly 0.6 on it?

Yes. Great question. So the study is designed for both a hazard ratio of 0.6, but also a 3-month improvement in the progression-free survival. Keeping in mind that time and remission is about 4 to 6 months for these patients. So we can extend that by an additional 3 months. We think that's both statistically significant as well as clinically significantly relevant. So this will be really important, that benefit both for patients and physicians, as they make that decision. And again, we're confident of kind of that bar based on the early data that we talked about, where 1/3 of the patients had that disease control at least 6 months. So if we can show that 3-month benefit now over kind of the placebo, we're confident we can achieve that in these early lines of therapy if we can achieve that in the later lines of therapy.

Got it. And Jatin, for the prior chemo regimen that patients are on, is there any synergy between how selinexor works with those prior chemos? How do you guys think about that?

Yes, absolutely. So there's great data showing that selinexor is actually synergistic both with Carbo/Taxol. There's actually a trial -- an IST trial where we looked at the combination of selinexor and Carbo/Taxol, showing very high response rates with the combination chemotherapy. So we know that when we combine it with chemotherapy, or even weekly paclitaxel, there's some very nice activity that we saw in both of those 2 trials that have been previously published. That's, however, distinctly different than what we're talking about here because, remember, in the SIENDO study, patients get their chemotherapy, the standard chemotherapy that all the oncologists are comfortable with. After they've completed it is when they go on to a selinexor versus placebo. So there's less of the issue of the synergy with the combination chemotherapy, but it's really building upon what the current standard of care is and then add in to that.

Got it, makes sense. And this trial is potentially going to read out by year-end '21, early '22, which could imply patients are doing better than expected in either the treatment arm, control arm or both. Can you comment on whether discontinuation rates and other observations are balanced between both arms? Or are you seeing some differences there?

Yes. Great question. So just to remind, the study is blinded, so we're unaware of kind of the actual trial data in each arm. What I can share is that there's been multiple DSMB meetings that have occurred routinely over the life of the study. And there's been no safety signals or any other observations that weren't a change in the study design or any other safety signals that have come up. And that's important because these guys are very focused in the maintenance setting of having a regimen that's going to be well tolerated. They're exquisitely sensitive to that, especially in the maintenance setting. And the DSMB has a careful, close observation throughout the life of the study, including a futility analysis late last year and no change in study design, again, which gives us confidence moving forward. And the second point I'll highlight again is that the physicians that are enrolling to the study are enrolling briskly. Enrollment is on track. And that gives you confidence as well. We have treating physicians who have treated several patients on the study continuing to enroll and share their optimism about the study and what they're seeing. So those are all anecdotal data, but I think we have confidence both speaking with our treating physicians as well as the confidence in our DSMB.

Got it. Okay. And what's the bar on safety for this study? And what happens next after the SIENDO readout?

So again, I think with the safety, these are all left up to the DSMB. There's clear guidance that the DSMB has. If they see a safety signal that they weren't stopping the study or changing the study design, adding an additional monitoring, none of that's happened whatsoever. So the study has continued, really, unchanged since the beginning. So I think from a safety perspective, we're -- again, we're confident. If there is something there, the DSMB would have notified to us and we haven't seen that, so we're optimistic in that sense. And I think what happens after we read top-line results, I'll defer to Richard to talk about how -- what the next steps beyond that, but the plan is to meet with the agency and file for an approval or an NDA, sNDA after we have the top-line results.

Got it. Okay. And for timing for how that's going to work, do you think that could happen first half '22? Or what are your thoughts there?

In terms of the filing you mean, Maury? Yes, so I think we have great -- I mean, great teams that are working really hard to make sure that everything can be ready as soon as possible. pending the data and I think have shown in the past that they work incredibly efficiently and hard and engage with the agency really well. So I think in the first half, definitely, we want to be able to move forward and pending the discussions with the agency and move forward with the filing.

Got it. Okay. And maybe moving on to ASH and some of the other clinical data that you guys are generating. You've got a lot of posters and presentations at ASH coming in December. Can you walk us through what we should be focused on for the data and how they contribute to your commercial and clinical development plan?

Sure, maybe I'll turn it to Jatin. I think there's kind of 3 key areas. We have a lot of different papers, and maybe we'll focus people on 3, and then I'll turn to Jatin on that.

Yes, absolutely. Thanks so much, Richard. Yes, 3 key areas that I'll kind of guide you towards and 4 abstracts. So 1 is in myelofibrosis, very excited about that data. This is the first time that we'll show the public clinical data with once-weekly low-dose selinexor in patients with Jakafi refractory or myelofibrosis. So very compelling data that we see with single-agent activity with selinexor in that setting, where we show that about 1/3 of patients who've been on for at least 12, 24 weeks of therapy achieve a splenic volume reduction of 35%. Really, really important that today, we can talk much more about that, but I'll highlight -- I'll really kind of guide towards that myelofibrosis data. We can dive more into each one of these specifically, but I think that's one important data set to look at. Number 2 is the -- data in MDS. And there, we show with single-agent eltanexor, our second novel SINE compound with single-agent eltanexor in patients with HMA refractory MDS, we showed a 53% response rate. And there will be some updated data ASH around that, including in patients with primary refractory disease as well as improvements in blood counts as well. So really key important points around HMA refractory MDS, but I'll highlight you towards that. And the third is in the myeloma space, and I'll highlight 2 specific abstracts just to keep attention, too. And one is additional data with XPOVIO-based combinations post to CD38, and that will support our commercial positioning as well, both with combination with pomalidomide as well as in combination with Kyprolis. So you'll see some updated data there post CD38. And the fourth abstract I'll really highlight there is based on our data with combination with Velcade from our Phase III study, where we combine XPOVIO and Velcade in our Phase III study. And what we showed there in that abstract is actually really compelling data that's practically -- very important practically. And that's -- the starting dose was 100 milligrams in combination with Velcade, but we showed, actually, the median dose that patients had was 80 milligrams. So dose reductions are important, and not only important, but when you do that, those patients actually have a prolonged PFS of more than 16 months on therapy and a much better side effect profile. So dose reductions are an important lever as physicians get comfortable using XPOVIO. This is an important tool that they can use and giving them that confidence with the right dose, the right schedule for the patient. So it's a really important data set looking at the combination of Velcade in the right median dose for patients.

Got it. Yes, it sounds like some interesting updates. Maybe digging a little bit deeper into myelofibrosis. Can you talk about the number of patients that could be in that update? And what should we be looking for, for that one? And what happens next with that program?

Yes. Great question. So there will be early signals for that study. So 12 patients' worth of data we presented that abstract. Important -- I'll also highlight that it's going to be actually, oral presentation on Sunday at ASH. So an important time to listen in, because there'll be a lot more updated data presented there. A couple of things I'll highlight there from that specifically, I just want you to highlight, one is that the patient population that entered that study is important. Those patients had a median of 22 months of ruxolitinib. And there's a big difference if you've had 14 days, 3 months or 6 months. The longer you've been on a prior JAK inhibitor, those patients have much more resistant disease. So the patients on our study at 22 months of prior ruxolitinib, so they're heavily pretreated. And number two, 11 out of 12 had ruxolitinib refractory disease, not just intolerant to Jakafi, refractory to it, and then high-risk disease. So that's the patient population. Number two, we showed, really, the signals that we saw single-agent activity with that splenic volume reduction, not just the [ SVR ] 35 but also [ SVR ] 45 where we showed the reductions in that splenic volume size. And that's important, demonstrating clear single-agent activity of this drug in this setting. And the third thing I'll highlight from that study is actually when you look at the graph, you'll see a deepening response over time. It's not only at 6 months, but -- sorry, at 3 months, 6 months and 1 year of selinexor, you'll see the splenic volume reductions happening over time. So not only do we see it early, but you see it continuously, over time, deepening. And that's important because it highlights 2 things. The first patient is actually on for 114 weeks, so more than 2 years. So what that really starts to highlight is that these patients actually can tolerate once-weekly low-dose selinexor for a long time. But the median duration is more than 36 weeks, and it's still ongoing right now. So we expect that to increase. But the fact that the first patient has been on for 2 years and others have been on for more than 1 year really starts giving you confidence that, hey, these patients can tolerate low-dose selinexor long term and really speaks to the tolerability of the drug. And because of that, I think you'll see more updated at ASH that as these responses deepen, as we have more follow-up, we'll have some updated data around ASH hopefully showing more responses at that time, so we'll see.

Got it. Really interesting. And I don't know if you could say anything about the baseline characteristics on what the spleen sizes are for these patients.

I think we'll provide a lot of that granularity at the ASH meeting during the oral presentation.

Got it. Okay. And for myeloma, sounds interesting with the data post-dara and then also on the dose adjusting to get to the 80 mg and how that could be used commercially. Actually, some other companies I cover have dosing protocols where, basically, help the doctor make those dose adjustments. Is that something that you guys can crystallize for physicians? And how do you think about that?

Yes. So we have dose reduction tables that are there as part of our package insert for various side effects, right? But I think what this data does is actually give them confidence. Because what every patient and physician worries about is by dose reduced, might lose efficacy. And that's what everybody worries about. And what this data does, it actually gave you confidence. That's an important tool that you can use that will improve patient outcomes, improve your side effects and improve long-term tolerability, stay on therapy, deepening responses over time and having improved outcomes over the long term. So I think what this data does this give you confidence that this is an important lever that you can use to improve patient outcomes.

Got it. Okay. And for MDS, maybe if you can talk a little bit about that one and what the unmet need is there and where selinexor could fit in.

Richard, should I [ take this ]?

Go ahead, Jatin.

Good. Yes, absolutely. Now I'll highlight here, that's a very similar story to myelofibrosis. We're in MDS, there's a single class of drugs, HMAs that are approved in the front line. Short of that, there are no other therapies that's approved for HMA refractory MDS, very similar to the myelofibrosis study, single class of drugs, JAK inhibitors. No other approved therapies beyond JAK inhibitors. There's a clear unmet need in myelofibrosis. Same story actually in MDS, a single class of drugs, HMAs, no other class of drugs beyond that. So when you look for HMA refractory MDS, there's no approved therapies. There is some development that's happening with other therapies, but those are all in the frontline setting and not in the refractory setting that we're focused in. So when we look in that setting, with eltanexor, we showed a 53% response rate in that HMA-refractory MDS. So very compelling response that we see in that setting, and a clear unmet need and a clear opportunity in that setting where nobody else is focused in. And with that, we've accelerated our program there. And so we've launched a study with the first patients already dosed, looking at eltanexor as a single agent in HMA refractory MDS, so that trial is ongoing currently.

Got it. So pretty well-defined patient population? What are the longer-term plans for this opportunity?

So I think very similar. We -- I think there's a clear opportunity there and a clear need there and a clear signal. So we're now continuing to confirm that with a single-arm Phase II study, looking at eltanexor single agent in that patient population. We plan to enroll 83 patients in that study. And then based on that data, we'll have further conversations.

Got it. Okay. And let's see. Maybe if you can talk about high-level strategy for R&D spend moving forward? And how should we think about the size and scope of a potential EU partnership for XPOVIO? And how does SIENDO factor0 into that EU plan?

Yes. So a few different questions there together. I mean, I think overall, I mean, as you know, we have an Investor Day in December. So we'll talk to some of those higher-level things from a spend perspective. As you see and as Jatin talked about, with the opportunities we have in front of us, really key opportunities for us to deliver on in very high unmet need opportunities with a big impact for patients. And so those are the areas we're focused on, and we're well funded to do that with a cash runway through to the middle of '23. And when we think about an EU partnership, again, what we're focused on is making sure we have an EU partner in place for the first half of the year when we have the potential approval on our second line plus, kind of the BOSTON label in the EU. And we want to make sure we're bringing a partner on board that really has the ability and has the belief in the short kind of medium and long-term potential of selinexor in the hematological side but also on the solid tumor side. So obviously, with SIENDO data potentially in front of us with potential approval in the first half of the year, a number of key areas moving forward. And I think just a great opportunity to bring selinexor to more patients around the world. As you know, we have a really strong partner in Asia, Antengene. South Korea has just recently been improved. I think we're looking at some other approvals, in the very near term, in Asia and continuing to really expand our breadth globally is what we're excited about.

Got it. And for larger studies for running those, would you potentially partner based on that? Would it make sense to -- for, I guess, particular indications?

Yes. I think right now when we're looking at how we're moving forward, I think we're comfortable in the areas we're focused on. And I think from the work that's been done to get us to where we are, we have a real breadth of data across many different types of tumors, many different types of cancers. So that's allowing us to focus on the areas we want to focus. And then as we move forward, we'll continue to do some activities and signal-seeking activity on top of the 4 key areas we have and find what that next generation of opportunities are. But right now in front of us, to deliver on these 4 is exciting, and I think a big impact for patients.

Got it. And maybe a quick question on Phase II that you guys have posted for selinexor plus pembrolizumab, which started recruiting in June. Can you just provide a status update on that program?

Jatin?

Yes, absolutely. Thanks for that question, and highlighting that, we're excited about that kind of -- and it's one of our kind of signal-seeking studies where we're confirming some of the early signals that we saw that potentially, selinexor can overcome resistance to checkpoint inhibition. So that trial is open in patients with relapsed melanoma who have seen a prior checkpoint. That enrollment is ongoing at this point in time. And as data matures, then we'll share that next.

Got it. Okay. Well, I think we're almost out of time. A lot going on commercially and in the development side at Karyopharm. But maybe in the last minute left, if you can go through key catalysts ahead that investors should be focused on for the remainder of the year and going into next year.

Yes. Thanks, Maury, a great, great conversation that we've enjoyed. I think when you look at what we're focused on for the remainder of this year and early next year, you've heard it right now, it really is the ASH data in front of us with myofibrosis, an incredibly exciting data, more data on MDS, which I think is also incredibly exciting and just continuing in multiple myeloma as well, to build breadth of data in multiple myeloma and really supporting the positioning we put in place. So those areas in terms of ASH and the data are exciting for us. I think also progressing the trials in these areas. And so you've heard moving forward in these areas is critically important for us, and we've moved forward in some, but continuing to move forward as well in other areas and also progressing our XVd trial to have an oral option in multiple myeloma. The Investor Day. I think that's an area we're looking forward to be able to talk more to these areas to help people better understand the science, the opportunity and how we're evolving as an organization to really be focused on making a difference for cancer patients. And also, obviously, the SIENDO data, as we look at the SIENDO data towards the end of this year or early next year, depending on the events. So we have a busy few months ahead of us, but an exciting opportunity to be able to continue delivering for patients and really showing, I think, a promise that our science has across many different types of cancer. So we're excited about it, and we're busy, for sure, for the next few months.

Very good. Well, Richard, Jatin and Mike, thanks so much for joining us today, and it's great speaking with all of you.

Great. Thanks, Maury.