Jan van de Winkel: Thank you, Judith. I think that’s very clear. Let me take the HexaBody-CD38 opt-in rights for J&J. They have the right to take a decision yes or no for opting in. So after we give them the data from the dose escalation, the dose expansion data which we already have and the head-to-head data against the subcu data, which we are gathering very rapidly. We believe that we have the head of data next year and then basically hand over that data package to J&J. And then they have only a very limited time to say yes or no. And the opt-in they want to develop commit to develop that molecule in any indication they want to, but I think multiple myeloma is now at the number one I think indication for HexaBody-CD38 definitely with the new data now from the expansion cohort.
And then we will get a $150 million upfront payment and they pay for all and we get straight 20% royalty rather than a 12% to 20% royalty until some point in 2031 where we go from 13% to 20% in the tiered fashion. So next year will be an important year because then we will hand over the head-to-head data package on top of the dose escalation and the dose expansion cohort data which we already have in our hands. And we keep following the data at ASH, which we will present on a poster will be updated data from the abstract. So please watch out for that and Tahi already gave you some color on what to look for versus years ago daratumumab monotherapy data. But you can hear from the enthusiasm of the team here that we are really — we can’t wait San Diego and can present that data because we believe it’s very, very encouraging.
I think we should probably leave it to that upsell for the time being.
Etzer Darout: Very good. Thank you. Thank you for the additional color.
Jan van de Winkel: All right. Thank you.
Operator: Thank you. We will now take the next question from the line of Sachin Jain from Bank of America. Please go ahead.
Sachin Jain: Hi, there. Thanks for taking my questions. Just more follow-ons on the same topics if I may. So firstly estate on the CD38 Grade 5 events. Thank you for clarifying. One of the two was COVID. Was that the respiratory event? And any color on the patient characteristics with CV event just to get some color as to whether that was treatment related or not in your mind? And then just a follow-on on the Grade 5s. The abstract was obviously a May cutoff. Have you seen any Grade 5 events since that May cut off? So that’s on the CD38. Second topic is the 1046. You said more color at ASH. Just to clarify what you have met with the regulators by then so could you confirm your Phase 3 program at the ASH event? And then a follow-on on your clear efficacy comment, do I infer that as a response rate above the 20% for taxi you referenced? And any color on the duration of response you’re seeing? Thank you.
Jan van de Winkel: Thanks Sachin. Let’s see what my colleagues are willing to give you this information. Tahi can definitely comment further on the Grade 5 events for HexaBody-CD38 and I will ask Judith to think carefully about how to answer the question on 1046 and the ASH data as it relates to clarity on a potential Phase 3 trial as well as the bar for responses. Tahi maybe you can start.
Tahi Ahmadi: Yes. So I mean as I said I think earlier the one patient was a patient who passed away due to COVID and the other one was cardiac event. Neither of the two events were in our judgment and the judgment of the investigators or in the judgment of the DMC related to that — sorry in the studies. And if you look at the study that I referenced earlier you’ll see there is roughly like a 7% fish rate of Grade 5 events on these trials of patients passing away of all kinds of business not always related to drug. So at this point, we don’t really have in the assessment of the DMC safety signal with small patients that in any way or shape or form seems to deviate for what is known for the class of CD38 antibodies. I hope that answers it.
Jan van de Winkel: Thanks Tahi. And then Judith on 1046 and ASH potential updates there or further clarity on the program. .
Judith Klimovsky: Yes. So thank you for the question. I think that we will try directionally to give more color just to share the design we expect to have more certainty on that and this usually happens after discussions with health authorities. So we give as much as we can predicated on where we stand in the process. As related to the benchmark I alluded to the multiple data sets in this setting that unfortunately failed and failed because they haven’t done or they didn’t do this rigorous scientific approach question by question to connect the dots and have the best potential hypothesis. And this allow us to wait a little bit to have not only but duration which is critical time to event is the right endpoint in a Phase 3 setting. So I mean, I want to reinforce that we will share as much as we can whenever we can. The commitment is there, but we are bound to when these meetings will happen. .
Jan van de Winkel: Thanks Judith and thanks Sachin for the questions.
Sachin Jain: Thank you.
Operator: Thank you. We will now take the next question from the line of Kaveri Pohlman from BTIG. Please go ahead.
Kaveri Pohlman: Yeah. Good afternoon. Thanks for taking my question. My first question is for Jan. Can you provide any insight into your expectations for its efficacy in CD38 pretreated patients given that previous studies have shown that these patients develop resistance via overexpression of complement inhibitory proteins? And my second question is for EPKINLY. Can you provide any color on your plans for follicular lymphoma and any time lines around that? Also for EPKINLY in DLBCL especially from the safety standpoint are you planning to have some real-world data collected that could further differentiated from its competitors?
Jan van de Winkel: Thanks Kaveri for the questions. I think I will hand both over to Tahi. Before Tahi starts, I already stated in an earlier comment we will intend to actually describe the compound development plan for EPKINLY in more detail — or epcoritamab I should say in more detail at the post-ASH update. But Tahi, maybe you can give us a bit more color on the efficacy of potential efficacy in CD38 pretreated patients.
