Cristina Suárez: Thank you very much for the invitation, my pleasure.
Tian Zhang: So tell us a little bit, we're going to talk about LITESPARK-033, but tell us a little bit about the development of belzutifan in general, what it is, and how it's come through for kidney cancer, and what impact it has had for your patients.
Cristina Suárez: Belzutifan, as you know, is a HIF-2 alpha inhibitor that demonstrated its efficacy in the VHL disease, so it's really a drug that changed the lives of patients with VHL disease. And also demonstrated to improve PFS in the LITESPARK-005 trial in patients that had already received PD-1 or PD-L1 treatment and TKI. So it's a drug that is available now in many countries, and hopefully will be in some others, and we can use for patients with VHL disease in second or third lines of treatment.
Tian Zhang: Great. And so certainly belzutifan has made an impact of all of our patients in refractory disease. Tell us what's different about LITESPARK-033, the trial that you're presenting in progress here at ASCO?
Cristina Suárez: So LITESPARK-033, it's exploring the role of a combination of drugs in patients that had already received adjuvant pembrolizumab. So we know that many patients now are receiving adjuvant pembro, but we don't have a standard of care treatment for those patients when they progress. LITESPARK-033, it's a phase III trial, including patients that have relapsed during or up to 24 months after the last dose of adjuvant pembrolizumab, with clear cell component.
And it's randomizing patients to receive belzutifan plus zanzalintinib versus cabozantinib. I don't know if we could say cabozantinib is the standard of care, but it's one of the most used drugs in this situation. And there is an unmet need for those patients when they progress to adjuvant pembrolizumab.
Tian Zhang: So considering post-immunotherapy treated patients who may not be candidates for more immunotherapy combinations in that frontline setting, is that the gist of the trial?
Cristina Suárez: Yeah, exactly.
Tian Zhang: Excellent. What are the right patient populations, and have you started enrolling the trial at your center?
Cristina Suárez: Yeah, we just started enrolling patients not long time ago, so we don't have still too much follow-up. So patients are, as mentioned, patients that progress to pembrolizumab and have metastatic disease, measurable disease, of course, patients with performance status. As usual in all the trials that include belzutifan, we need hemoglobin of at least 10. It's just something that we used to see and we were not so used before using HIF-2 alpha inhibitors. Usually in the trials it's nine. Yeah, that's a target population.
Tian Zhang: Very good. Any difficulties enrolling for the moment, or where is the trial globally in launching?
Cristina Suárez: We are recruiting well right now, but the big challenge I think is going to be to find this population because also there are many patients that unfortunately progress to adjuvant therapy is not such a big population like patients in second line or third line or [inaudible 00:04:06]. So I think this will be maybe the major challenge for the trial.
Tian Zhang: Right. And in our centers, are most of your patients receiving adjuvant pembrolizumab so that you can capture them in that two year space after adjuvant treatment?
Cristina Suárez: Yeah. Most of the patients are, at least we give them the opportunity to receive adjuvant pembro, all the patients that meet the criteria of the KEYNOTE-564. And yeah, most of them are receiving the treatment.
Tian Zhang: Got it. But for the population that we're trying to capture, it will be all of the patients who have received adjuvant pembro.
Cristina Suárez: Yeah.
Tian Zhang: Great. Anything else you would want to add about the trial?
Cristina Suárez: No, I think it's an exciting trial and I hope everybody's as excited as me, and we recruit well.
Tian Zhang: Great. Yeah. It's certainly answering an important question in post-adjuvant pembro space. So congratulations on presenting the trial in progress.
Cristina Suárez: Thank you very much.
Tian Zhang: We're looking forward to seeing the trial unroll.
Cristina Suárez: Thank you very much.