Michael Schmidt: Great. Super helpful. And then lastly, on LOTIS-5, it sounds like you’re well on track to complete enrolling here later this year. And — just curious if you had any additional visibility on the event rates as they’re coming in and sort of the timing of the primary analysis? Thanks so much.
Ameet Mallik: Yes. I mean as you said, and I’ll turn it to Mohamed, to comment further. But we’re on traffic, we decided. The enrollment pace has picked up quite a bit over the course of this past year and even this year, in particular, has picked up quite a bit. So we’re confident in completing the enrollment of the study this year. It’s an event-driven trial, so you can never predict the — when it is going to exactly read out. But based on our current thinking, we believe it may read out as soon as the end of 2025, which if that’s the case, and it’s positive, could lead to an approval as soon as the end of 2026. But Mohamed, do you want to comment more on the enrollment and what you’re seeing with LOTIS-5?
Mohamed Zaki: Yes, we’re very pleased with the current enrollment. It picked up strongly during 2023 and 2025 release. We are still — and I believe that we will be able to enroll the study this year, things are moving very well. Also, we have a DMC that meets regularly that have cleared the study multiple times, no changes. So that’s a very positive sign. In addition, I would like to say that the events are being reviewed by independent sensor review. So that’s another very key element for us to make sure that those are confirmed. And then completely independent, as you know, we’re blinded, but it’s an event-driven study and stick until next year, that’s a positive thing. And hopefully, that would remain the case. So that’s pretty much all about good sign at the moment.
Ameet Mallik: Yes, I think all on track with LOTIS-5. We feel good about the progress and we’re well on track to complete it this year.
Michael Schmidt: Great. Well thanks so much. Congrats on the update today.
Ameet Mallik: Yeah, thank you.
Operator: Thank you. And our next question will come from Gregory Renza from RBC Capital Markets. Your line is now open.
Unidentified Analyst: Hi, this is Clifford [ph] on for Greg. Thank you so much for taking our questions. And congrats on the progress. I have questions on the competitive dynamics from CD20 bispecifics. Number one has the impact being fully realized, the impact of the competition from CD20 bispecifics on ZYNLONTA, has been fully realized in a third-line setting. And now the Roche recently announced that the trial in the second line hit the primary endpoint and it could potentially be ahead of ZYNLONTA combination from LOTIS-5. I’m just curious how should we think about the competition from that — the bi-specific combo to LOTIS-5? Thank you so much.
Ameet Mallik: Yes, that’s a great question. Yes, the bispecifics, both of the approved bispecifics in the third line plus DLBCL setting are definitely getting uptake, primarily in the academic center. We see much more limited use in the community. So in the academic center, there is quite a bit of use of bispecifics post CAR-T. I think importantly, we still have seen some modest growth, though, in the academic centers overall in our volume when you look at Q4 to Q1. What that’s been driven with is while you have some lower level of depth in some centers that we’re using ZYNLONTA quite a bit in that setting, we’ve actually seen a higher amount of breadth of centers and academic centers that are using the product. And so in essence we’ve been able to basically compensate for a lot of that competitive impact, although it’s real.
I mean bispecifics are definitely being used quite a bit, and you could see that in their growth rates a lot in that third line plus post CAR-T in the academic setting. So we’ve felt the competitive impact. I think, importantly, though, we’ve been able to largely offset it in an academic center, and we see continued growth in the community as well. So we think our strategy is working. In terms of the data around the glofitamab plus [indiscernible] combination. We’ll have to look, we have to wait and see the data. Obviously, it hasn’t been published. They give top line results. I mean one thing of note, I think, is just that they said that the — I think that what we’ll have to pay attention to is what’s the toxicity profile. We don’t know. But obviously, using systemic chemo with a bispecific, you’ll have to see what the toxicity profile looks like.
I think there — we feel quite confident, I think, in our combinations both of ZYNLONTA plus rituximab as well as ZYNLONTA plus glofitamab given the toxicity profiles we’ve seen there. So I think as we move into the second line, it’s important to have strong efficacy and manageable safety tolerability profile. We feel confident in both of our approaches.
Kristen Harrington-Smith: I don’t have much to add to me. Yes, we’re excited to see this star load data that will be out at EHA. And as Ameet said, we’ve been able to hold share pretty much in the academic centers. We see that despite the bispecifics, we have strong advocacy in the academic centers. And what we also hear is that these advocates recommends ZYNLONTA to the community treaters, which is critical. Once we see the data from LOTIS-5, the briefing is that rituximab is probably one of the most commonly used agents out there with a lot of familiarity, so between LOTIS-5 and LOTIS-7, we offer great optionality with ZYNLONTA.
Ameet Mallik: Yes. It’s a really, really important point that Kristen just made. One of the most predominant use is, we know that CAR-T is only used in about 20% of patients second line really in the academic center. The majority of patients in academic centers are getting it. In the community though, our base chemo regimens are very, very commonly used. So we think in our based ADC approach is going to fit really well there.
Unidentified Analyst : Alright, thank you so much.
Operator: Thank you. And our next question will come from Brian Cheng from J.P. Morgan. Your line is open.
Brian Cheng: Hey guys, thanks for taking our questions this morning. Maybe just the first question on LOTIS-7. Can you talk a little bit more about the strategy beyond those expansions in LOTIS-7. Will there be a need to run a larger second-line pivotal study to get you officially move into the bispecific — move in of the bispecific combo? And if yes, how do you think about the study design and the timing? And I have a follow-up, thank you.
Ameet Mallik: Okay. Yes. Thanks, Brian. Great question. I’m going to hand it to Mohamed to answer the question on LOTIS-7.
