And so, we’re looking forward to having discussions with the agency in 2024. That’s about all I can say with regard to CABINET. And when it comes to CONTACT-02, I think I’ve already mentioned we are anticipating final OS results sometime in 2024. However, we believe that the data that we presented at ASCO GU represents a data package that sufficiently supports the totality of clinical benefit in the ITT patient population. We’ll have ongoing discussions with the agency on how best to bring that in front of them.
Etzer Darout: Great. Thank you.
Susan Hubbard: You’re welcome. Operator next question, please?
Operator: Our next question comes from the line of Peter Lawson with Barclays. Your line is open.
Peter Lawson: Great. Thank you. Just a question around guidance. Thoughts on pricing and volume in 2024, especially in light of IRA and any kind of seasonality that, we should be thinking about for revenues through ’24?
PJ Haley: Yes, Peter, it’s PJ. Thanks for the question. The IRA is clearly now in play this year. What that means specifically is our price increase is 2.2%, as we certainly didn’t want to incur any inflation-related penalties there with regards to our revenue. The real good news for patients there in terms of Medicare, is that the patient out-of-pocket will be limited this year to approximately $3,300. Next year, that will be $2,500. And it’s really early days from what we’re observing there, but obviously, good news for patients with the potential to have those lower out-of-pocket costs. So, we’re keeping a close eye on it. And yes, we’ll track it and update as available.
Peter Lawson: Great. And anything we should think about as regards to seasonality for the year?
Mike Morrissey: Yes, nothing we would comment on here, Peter.
Susan Hubbard: Thanks, Peter. Operator we have the next question, please we are getting close to the top of the hour?
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Kaveri Pohlman with BTIG. Your line is open.
Kaveri Pohlman: Yes. Good evening. Congrats on the progress. And thanks for taking my question. Regarding the Phase 2/3 head and neck cancer trial for zanza and KEYTRUDA, is it mostly to replace KEYTRUDA monotherapy that is used in patients, with lower tumor burden? Or you also expect it to work better than KEYTRUDA and chemo combination for bulky disease?
Amy Peterson: Yes. Sorry, Kaveri very quickly. This is a study that is just zanza pembro versus pembro. There is no chemotherapy-containing arms. So the former not the latter, right, replacing monotherapy KEYTRUDA.
Kaveri Pohlman: Yes. I just kind of like wanted to know that KEYTRUDA monotherapy is mostly used in lower tumor for the patients. Is that what you will be focusing on in your trial as well.
Amy Peterson: So harkening back to some of the comments I made earlier, the study has inclusion and exclusion criteria. Some of the inclusion criteria require that, for example, the tumor has to express the CPS score greater than 1%. There’s not necessarily a limit on tumor burden. So again, we go to equipoise. What study – is the treatment arm, either treatment arm reasonable for the patient sitting in front of the physician in order to randomize? I can’t speak to what burden of disease they would enroll in the study.
Susan Hubbard: Great Amy. And operator let’s take our final question, please.
Operator: Thank you. Our final question comes from the line of Christopher Liu with the Leerink Partners. Your line is open.
Christopher Liu: Thanks for the question. On CONTACT-O2, you guys had a median duration of tumor exposure four months and median progression-free survival of six months. Just wondering what the key driver of that difference was? And then just a quick second one. Do you guys have a few ADCs in the pipeline? Just wondering what the technology is driving that. Is it still [indiscernible]?
Amy Peterson: So, I’ll take the treatment exposure question. I think we actually presented at ASCO GU that we had dose intensity of 94% with cabo and 83% with atezo. The median duration of therapy being disconnected with the PFS can be for a variety of reasons. Patients take chemotherapy breaks, they restart, they get dose reductions, they restart. So yes, it’s not anything that I can elaborate on at this point in time.
Mike Morrissey: Good. Dana, final answer?
Dana Aftab: Sure. Yes. So for the newer ADCs in the pipeline, we’re not using Zymeworks. That is primarily through the SMARTag technology with Catalent.
Mike Morrissey: Yes, I’d recommend if you’re interested in the details, we had a pretty fulsome discussion around all that information at the R&D Day in December. So take a look at the webcast, and I think you’ll have a very deep understanding of how broad we have the platform built around both linkers and warheads with various EDCs.
Susan Hubbard: Great. Thank you, Mike. And with that, we’ll thank everybody for joining us for the call today, for your attention, for your questions, and we’re certainly available to take any follow-up you may have. Have a great rest of your day.
Operator: Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.
