Operator: Thank you. Our next question comes from the line of Boris Peaker with Cowen. Your line is now open.
Boris Peaker: Great. Thanks for taking my questions. I want to focus on the screening folate receptor alpha. You mentioned earlier that about 1,500 patients were screened that would have been like in the last month of the year. Can you comment how many patients have been screened since the time or maybe in ’23? And also, you mentioned that many of the tests are being done in newly diagnosed patients. Can you mention why are docs doing this if they really don’t have a therapeutic option based on this test for newly diagnosed patients?
Mark Enyedy: Yes. So what I can say about testing is that the rate has increased since the — so we basically did 1,500 tests in the first six weeks from approval through the end of the year, and that the testing rate has increased as we moved through the first two months of 2023. And we’ll provide hard data when we have the next earnings call in terms of the actual quantity of test. In terms of why does the physician want to assess FR alpha status in a newly diagnosed patient, what we see from this physician group is they’ve become very accustomed over the last several years, initially looking for BRCA mutations and more recently for homologous recombination deficiency to really understand the genetic profile completely of the tumor.
And so the adoption rates, quite candidly, and for newly diagnosed patients have exceeded our expectation. And it is because of the way in which this physician base has evolved in terms of their initial work of the patients. And so — and the other thing it does is, it reduces any delay in terms of making a prescribing decision. So once they know that they’ve got an FR alpha positive patient, if that patient progresses to — within our label, there’s no need for a subsequent test. They can use the previously available data and advance the patient on to ELAHERE immediately.
Boris Peaker: Great, thank you very much for taking my questions.
Operator: Thank you. Our next question comes from the line of Andy Hsieh with William Blair. Your line is now open.
Andy Hsieh: Great, thanks for taking our questions. I have one about maybe potentially detecting on OS signal for MIRASOL. I remember the PS2 plus the analysis was pretty provocative from FORWARD I, and that was over a little bit – it was a little bit over 100 patients versus 450 with MIRASOL, so just trying to understand the ability to detect that signal?
Anna Berkenblit: Yes, thank you, Andy. So your memory is absolutely correct. In FORWARD I, we had actually quite a strong trend even in the 10x, if you will, for alpha high patients favoring mirvetuximab in overall survival. And in the PS2 plus, so the properly identified FR alpha-high patients, there was a very nice signal for OS favoring mirvetuximab over investigator choice chemotherapy. You’re right, in a relatively small subset, and it was post-hoc. And so, all of these reasons make us confident that overall survival in MIRASOL will trend strongly in favor for mirvetuximab over chemotherapy, and my prior point that we’ll have greater than 60% of the events. So the OS data will be relatively mature and interpretable at the time of the primary PFS analysis is important.
You’re right, we enrolled a little over 450 patients. So the study does have reasonable power to detect a statistically significant improvement in overall survival, but we do not need that for regulatory approval, either in the U.S. or Europe. No drug in ovarian cancer has been approved based on an overall survival benefit. So as long as we see a positive trend in the right direction, we’ll be fine. And there is a chance we could hit statistical significance. Again, the stronger the OS data, the easier the conversations are in Europe, particularly around payers and access and the value proposition.
Andy Hsieh: That’s very helpful. And maybe from a modeling perspective, looking at the GLORIOSA study, I’m just curious, how should we think about the performance in terms of PFS for the Avastin control arm?
Anna Berkenblit: Yes, so that’s a good question, Andy, and it’s not one that can be easily answered based on the data from published studies looking at the triplet in and of itself, because the PFS data from, say, the OCEAN study and the GOG 213 study is counted from the date of randomization for the triplet and then continues on, including the triplet duration and then as well as the Avastin maintenance component. So our study, you may remember, we randomized patients at the time of maintenance. So any patient, as long as they have not progressed, will be randomized to MIRV BEV versus BEV maintenance. And so with that, we’ve worked with our statisticians to do some modeling. And I think it’s clear we have a very clear understanding of that.
That has guided the sample size and the hazard ratio, et cetera, that we have used to design the study. I think we’ll leave the details for that for another time. But I think the important point is that for those patients who have not progressed, Avastin maintenance has modest efficacy. And I think with mirvetuximab plus Avastin, based on the strength of our doublet data, we anticipate a long progression-free survival.
Andy Hsieh: Thanks, that’s helpful. Thank you so much.
Operator: Thank you. Our next question comes from the line of Kelly Shi with Jefferies. Your line is now open.
Kelly Shi: Thank you for taking my questions. This is a follow-up regarding the OS data to be released at the MIRASOL update. Just curious, you just mentioned the OS benefit will not be the basis for the full approval discussion. I’m curious that in the case if the median PFS benefit is less than 1.5 months over chemo, would the regulatory agency put more weight on evaluating less benefit? Thank you.
Anna Berkenblit: So Kelly, I really can’t answer your question because the point estimate for the median, if the point estimate for the medians are less than 1.5 months, that doesn’t tell me the totality of the treatment of mirvetuximab over investigator choice chemotherapy, where hazard ratio is the most appropriate statistical measure. And so, what I would say is we anticipate a statistically significant improvement in progression-free survival with a p-value less than 0.05. And the point estimates for the median for each arm will be what they will be. And then overall survival will certainly be part of the overall assessment that FDA does when they look at benefit risk.
Kelly Shi: That’s helpful, thank you.
Operator: Thank you. Our next question comes from the line of Asthika Goonewardene with Truist. Your line is now open.
Asthika Goonewardene: Hi good morning guys and thanks for taking the questions. Quick one on the ELAHERE commercial rollout suggested that one of your diagnostic vendors, NeoGenomics, has some issues with processing, and this was causing some delays in testing around. But as far as we understand that these issues have recently been resolved. I just want to confirm that this is indeed the case and that there is, no testing bottlenecks now? And then related to that, was the $30 million to $35 million guidance of ELAHERE sales for this year based on sales made during that period when you had this bottleneck or is it purely taking into account the more recent run rate? And then I have a quick follow-up?
Mark Enyedy: Yes, so no bottleneck in testing. All four of the central labs are up and doing very robust business. The fourth lab is a small regional lab in Las Vegas. But the three key labs, which include Labcorp, NeoGenomics as you mentioned, in cares, are doing large volumes of testing, and there’s no bottleneck. We’ve not given revenue guidance for ELAHERE, and we’ve deliberately done that given the early days of the launch. Obviously, many of you have provided your own estimates, and we look forward to reporting out data on a quarterly basis as we move forward. What we’re trying to do with you is give you a qualitative assessment of how the launch is proceeding based on what we think are the important metrics. And so, as we’ve discussed, testing has exceeded our expectation.
Adoption in the community has exceeded our expectation. Our academic accounts are our largest accounts, as we would have anticipated. And we continue to work nicely through the coverage decisions, and we started with a strong base at the beginning of this year, and Tom and his team have done an exceptional job in terms of improving both our Medicare and commercial coverage. The engagement with the compendia has been positive to include the combination. So all of the things that we would hope for, as a new entrant in the market have materialized nicely and our goal ultimately is to report out the quantitative metrics to go along with these qualitatives in regular order with – in connection with the next earnings call.
