John Miller: Alright. Makes sense. Can you talk about potential use of Vobra Duo in combinations, given the safety profile here? It’s obviously not an nocuous molecule and some of the doctors are overlapping with other agents that you might expect to see in prostate space. So, I am thinking about pneumonitis and pleural effusion, for instance. So, are you looking – what does this mean for potential use in combination and thereby uses in earlier lines of therapy compared to other programs that are enthusiastically pursuing larger combinations in early line therapy?
Scott Koenig: Well, again, we are very much interested in looking at combinations of Vobra Duo with different agents. And as you know, we initiated those finding studies with lorigerlimab, PD-1, CTLA-4, DART bispecific molecule. And as I commented earlier, we expect to be able to define the go-forward doses from the dose finding studies very shortly where we would not only look at this combination in prostate cancer, but in other tumors as well. And given that mechanistically, we believe these are very orthogonal mechanisms for controlling tumor and as we have already shown in addition to the Vobra Duo data that we described today, activity independently single agents of lorigerlimab in late-stage patients I think this will be a very good combination to explore, and we are looking at the potential of others as well.
John Miller: Got it. Thanks very much.
Operator: Our next question comes from the line of Etzer Darout with BMO Capital Markets.
Etzer Darout: Great. Thanks. Wanted to know if you could provide a little bit more color around sort of the combination with – specifically with lorudrilumab, given that you had sort of indicated that you could move into sort of dose expansion studies with Vobra and lorigerlimab in the first half, I believe. Maybe you could comment on where you are with that program? And is that still sort of a viable plan moving forward given the profile that we have seen today? Thanks.
Scott Koenig: Yes, so we are on track for moving forward with that. I think we are at the final evaluation of the dose-finding cohort of finding what the ideal doses of each one when put together to maximize both the safety and activity to explore. So, I think we will be in a pretty good shape in the second half of the year to initiate enrollment in the prostate and potentially another tumor indication. So, stay tuned for that.
Etzer Darout: Thank you.
Operator: Our next question comes from Mayank Mamtani with B. Riley Securities.
Mayank Mamtani: Good afternoon. Thanks for taking my questions. So, maybe on the look-forward basis, Scott, if you could comment on your expectations for the rPFS data, and how you may be able to present that in the next few months based on what you are seeing on durability, median cycles? And I think importantly, how you see – based on all of that you know, you see this split in the paradigm relative to PSMA steep one, when you think about sequencing, you think about designing your Phase 2 next year.
Scott Koenig: Yes. Thanks very much, Mayank. Right now, as I again laid out the parameters here as baseline, what we had indicated was in rPFS as baseline of 6, but greater and obviously, looking for 7, 8, 9, 10 or a higher. I think that the data that we show today and the fact that these patients are still on therapy. I think we will ultimately see the results, but there is no reason we can’t meet some of the longer-lived rPFS values here, so we will have to wait to seeing the results. The expectation is that this would be presented at a scientific conference in the second half of this year.
Mayank Mamtani: Got it. Thank you. And maybe just one quick clarification. There weren’t too many RLT exposed patients in the study. Does that has to do any kind of analysis if you could talk on that.
Scott Koenig: I am sorry, did you say radiotherapy?
Mayank Mamtani: Yes, R&D…
Scott Koenig: That’s true. And as you saw on the geographic distribution of the patients there were a very modest number of patients from the U.S. where they would have the ability to when we initiated the study and when the enrollment occurred, to either have seen physical [ph] or have progressed on that given the timing of the marketing of that drug in the U.S. versus Europe where the majority of the patients came from Western Europe. So, we expect small numbers of those patients in this study.
Mayank Mamtani: Got it. Thanks for taking my questions.
Operator: Our next question comes from the line of Silvan Tuerkcan with Citizens JMP Securities.
Silvan Tuerkcan: Hey. Good afternoon and thanks for taking my question. First of all, when could we find out about the adjudication of the death, if they are treatment-related or not? Would that be available by the time we get that presentation at a medical conference in the second half?
Scott Koenig: I would presume so. Obviously, we are giving you ongoing results as they come in. I mean we are here in early-May and as we just did this data cut in April. So, the expectation is, the teams are working very hard in finding out the details on the patient study and evaluating comorbidities and other things that may have contributed to the specific deaths [ph].
Silvan Tuerkcan: Alright. But the DSMB is looking at these, right, presumably between…
Scott Koenig: Absolutely.
Silvan Tuerkcan: And then maybe talk to me maybe if you can walk me either through the waterfall plot or basically, I am trying to understand or reconcile the unconfirmed responses. There is a fair amount in especially high – in the high-dose arm, where your confirmed response rate is 25%, but it could be with the unconfirmed as high as 43%, are those responses, the majority, why are they not comforted are they still ongoing, do the patients are not scanned yet, or could you please characterize that?
Scott Koenig: Well, yes, I mean that’s very – if I look at the plots there of the spider plot, say, for the 2.7 the time – the timing frequency with regard to the scans is every eight weeks. And so again, if you look at the majority of these patients, if they were still on therapy as of 16 weeks would have had two scans. Those that had achieved 24 weeks would have had three scans, and there is at least one patient that probably had four scans. So, for instance, if you look at the patient with 2.7 mg per kg for the one on the top of that curve, they had initial evaluation for a PR that he achieved at eight weeks, the first scan. But it wasn’t until the – probably the fourth scan that it was confirmed as a confirmed PR. So, the bottom line is that it will take a longer time. And I mean there are a number of patients I see here that have one positive value and have not gotten the second scan yet to confirm it.
Silvan Tuerkcan: Great. Thanks for taking my questions.
Operator: Our next question comes from the line of Kelsey Goodwin with Guggenheim Partners.
Kelsey Goodwin: Hey. Thanks for taking my questions. I guess given the early looks at durability with the spider plots for the RECIST evaluable patients, at least, I guess do you have any update on how you are thinking about where durability may land for the fall update, or just any additional color you could provide there? Thank you.
Scott Koenig: Yes. And I think it’s just too early to say, given that, again, the majority of patients are still on, for example, the 2.7 mg per kg in the patients with measurable disease. We have as noted here on the slide, 62.5% that is still ongoing treatment. So, again, we feel very encouraged that given even at this point, that we should be able to have an opportunity to treat a large number of these patients with mCRPC.
Kelsey Goodwin: Got it. Thank you. And for the non-RECIST evaluable patients, I guess did the spider plots kind of – are they representative for the non-RECIST evaluable patients as well as this…?
Scott Koenig: Yes. Again, what we wanted to do is give you a representative feel for the various durability. And we felt that this was a good representation with regard to RECIST evaluable with measurable disease at baselines. But I would say that our general view is that this can be extended to patients with bony disease as well, etcetera. And so we are just – we have this balance that we want to provide investors a look at the data as we had promised, but at the same time is having additional data that we can then present at scientific conferences. But nothing here is more selective in that regard.
Kelsey Goodwin: Got it. Okay. Thank you so much.
Operator: Our next question comes from the line of Peter Lawson with Barclays.
Peter Lawson: Thank you. Thanks Scott for the update. I am just wondering if you could possible to characterize what the spider plots look like? And if there is these patients are staying on the PSA50 reduction or PSA reductions improving over time or kind of the best way you could potentially characterize that.
Scott Koenig: Yes. Again, what we started to do is give you a capsule so, but I would say that the apider plots are exceptionally encouraging. As we had shown in the Phase 1 data, you will see initial reductions in PSAs and they seem to be sustained for long periods of time and the time interval at least at this interim data going forward. Clearly, there are individual patients that will not have the continued PSA50 responses, but I would say as we characterize Phase 1, they do very well similarly over a long period of time.
Peter Lawson: Got it. Thank you. And the PSA50 reduction was higher in that lower dosem, was that driven by a lower discontinuation rate, or is there something else going on?
Scott Koenig: I think this is just idiosyncratic. I would not over interpret these, even though these are nice size populations, I don’t think there is anything of particular. I would more look at the – I mean the 50-50 with regard to the patients that had at least one PSA50 reduction, I think says that both populations are seeing similar even though the confirmed ones seem a little lower on the 2.7%, I think it’s just spurious in that regard. And as I pointed out, is expecting that those numbers could potentially increase over time. So, I don’t look at that as estimate or parameter of the difference at this point.
Peter Lawson: Thank you. And then final question, whether the PSA reductions or if it’s ORR or disease control rate, what correlates best in your mind for this agent and PFS?
Scott Koenig: My sense, it’s going to be our PFS and disease control rate. As I pointed out previously, avoiding new growth of lesions is the most important thing here. And so that, obviously, if a patient has 30% or greater percent, it’s recorded as a PR, but if a patient has 20% reduction will be recorded as a stable disease. As long as there are no new lesions, I think that is fine. But again, we will have to see as the data continues to mature.
Peter Lawson: Okay. Thank you so much.
Operator: That concludes today’s question-and-answer session. I would like to turn the call back to Dr. Koenig for closing remarks.
Scott Koenig: Well, thank you everybody for your questions today and we look forward to following up the completion of the TAMARACK study and further updates on our other programs soon. Have a good evening.
Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.
