Reshma Rangwala: Absolutely. So as I mentioned earlier, right, I mean, this relapsed refractory, and I will actually say the patients that were enrolled as part of the Phase I and also in the Phase II are the hardest to treat patient population. I mean, in fact, these are these primary HMA refractory patient populations. Survival is extremely short, unfortunately, in this patient population with published data indicating median survival of only 4 to 6 months. We’re very highly encouraged by the Phase I data that we presented at ASH ’22 specifically the median overall survival of those patients treated with Eltanexor was approximately 10 months. With that improvement in overall survival that again, we hope to see as part of this Phase II.
It will allow us to best determine the registration path with Eltanexor in this patient population. In terms of the Endometrial cancer, again, very encouraged by the updated PFS results that we’ve observed from the November ’22 cut. Median PFS for the Selinexor patient population has increased from 13.7 months to now 20.8 months. On Overall, survival is still immature. And so we’re continuing to follow those survival data. But these data have very much informed our current Phase III trial, EC-042, and are encouraged by the benefit that these patients can achieve in this EC-042 trial.
Operator: The next question comes from Eric Joseph of JPMorgan.
Eric Joseph: Just a couple of Endometrial cancer. One around this PFS update. Reshma, can you just talk about how closely duration on treatment lines up with the extended benefit on PFS? And then secondly, I’d be interested to get a sense of how site participation or the regional mix of patient enrollment will kind of line up between the EC-042 study and the experience in SIENDO.
Reshma Rangwala: Eric. Great question. So as we look at the updated PFS, we see an increase going from 13.7 months to 20.8 months. We also see a proportional increase in that duration of therapy, too. So that duration is driving progression-free survival benefit in that patient population. We’re going to continue to follow not only the duration, but the PFS and OS in this trial. In terms of site activation, there’s a lot of activity that is happening within EC-042. One of the benefits that we can leverage is actually our experience with the SIENDO. We had approximately 100 sites as part of the SIENDO trial that included sites from the GOG and ENGOT. With EC-042, we can identify the highest performing sites and incorporate them into the EC-042 trial as well as add additional sites. I’d say that because in this EC-042 trial, we’re actually looking to activate approximately 140 sites in the U.S. and Europe.
Eric Joseph: Okay. Got it. And maybe just a follow-up, if I could, on Myelofibrosis. I know that starting the Phase III trial is depending — is pending regulatory feedback. I guess I’m wondering if there’s any reason to think that the Phase III trial design should — may not — I guess, is the MANIFEST II trial, a good proxy for how the Phase III design with Selinexor should look?
Reshma Rangwala: Yes, good question. I mean, yes, right? I think we know in first line on SVR and TSS50 are the key end points about the physicians are interested in, but also the regulatory agencies are interested in. So we know those are going to be the endpoints in which we design our trial and it’s going to be a relatively simple comparison, right, just comparing the efficacy and safety of the combination of seli plus rux to rux alone. So this is going to be a very traditional trial but optimizes our ability to demonstrate the benefit that patients can achieve with the combination compared to rux alone.
Operator: The next question comes from Ed White of H.C. Wainright.
Edward White: You had mentioned several times that the — you’re seeing an increase in the duration on therapy in the second to fourth line patients. I’m just wondering if perhaps you can quantify that and perhaps give us an indication of what you’re seeing in the fourth quarter of this year versus the fourth quarter of last year.
Richard Paulson: Yes. Sohanya, do you want to take that one?
Sohanya Cheng: Yes. Thanks for the question. So on duration, when we look at it year-over-year, and it takes time for this data to mature, we do see an upward trend in our duration year-over-year. And this is really driven by 2 factors that increase in the proportion of patients in earlier lines who are staying on therapy longer, but also it’s driven by effective management of these patients with dose adjustments and supportive care. Now as the data matures, we see an increase in proportion of patients reaching cycles 3, 4 and 5 in 2022 versus 2021. In the out end of the range, as you know, patients — there’s a broad range of patients staying on therapy. On the outer end of the range, we do see patients on XPOVIO over 2 years of therapy and over time, positions are getting increasingly confident in managing these patients.
Operator: The next question comes from .
Unidentified Analyst: This is on for Jonathan. Just a couple initially on the Myelofibrosis update in the first half. Can we expect to see any week 48 SVR35 data there? And then also for the TSS50 by chart review, I was wondering if you could elaborate on how that may or may not differ from how that data is typically collected. And then second question, I was just wondering how do the late-stage trials in treatment-naive Myelofibrosis influence your trial design or your thinking on that opportunity?
Richard Paulson: Thanks, Matt. I’ll turn to Reshma for those.
