Andrea Juliana Gomes: Thank you for having me.
Zachary Klaassen: So the LIBERTAS trial, just level set for our listeners what this trial is and what the trial design was for LIBERTAS.
Andrea Juliana Gomes: Briefly, LIBERTAS, it's an ongoing global randomized phase three trial that is focused in de-escalate ADT in mCSPC population. It has two parts. The first part of the study, 420 patients receive a combined therapy with apalutamide and ADT for six months. And between then, those who achieve undetectable PSA comes to the second part and they were randomized in two arms one by one. The first arm is to continue therapy with the combined apalutamide and ADT, and the second arm is the intermittent arm with escalating ADT. And the co-primary endpoints of this study are the radiographic progression-free survival and the hot flash burden. We want to understand the frequency and the severity of the hot flashes and the overall population, so it's a very interesting study.
Zachary Klaassen: That's a great background. I think we're seeing a lot of these intermittent deescalation trials now.
Andrea Juliana Gomes: Yeah.
Zachary Klaassen: And really, this hot flash question is one that we all deal with globally.
Andrea Juliana Gomes: Yes.
Zachary Klaassen: I think this is a super important study. Now, you've presented some data at ASCO this week looking at the Latin American population. Just give us an idea of the high level results from that-
Andrea Juliana Gomes: Yes. We want to validate the deep and rapid decline of PSA in the Latin American population. And the data from TITAN study, we have that the deep and rapid decline PSAs correlated with improving overall survival and better outcomes. So why we choose the Latin American for this time? First, because they count almost 30% of the participants, exactly 110, were Latin American. And the second because they have more advanced features like more advanced disease at the beginning at the baseline, like more high-volume disease, more high level PSA. The median PSA was 22.9.
Zachary Klaassen: Right.
Andrea Juliana Gomes: And the other regions of the study and the other participants were only 7.3-
Zachary Klaassen: Wow.
Andrea Juliana Gomes: ... so it's very different. And they have more de novo disease and they were younger than the other participants. The median age was 67 years old for them, so the Latin American population have a more poor prognosis than the others.
Zachary Klaassen: I see. And what did you see in terms of these deep PSA responses compared to the general population?
Andrea Juliana Gomes: They did very well. It's correlating with the other participants of the study. 95% of them achieved 50% of reduction in PSA. 87% achieved 90% of reduction and 60% reached undetectable PSA, and these results were very interesting and encouraging for us.
Zachary Klaassen: Yeah, absolutely. And I think when we look at that data, because you laid out beautifully the higher PSA, younger patients, higher disease burden, but still having great PSA responses. How does that, especially for your practice in Brazil, how do you take this back to the clinic when you're counseling patients?
Andrea Juliana Gomes: We first start with our conversations and observing how does filling the patients and what are their perspectives for the future. And we understand the combined treatment with apalutamide, it's a good option for them understand we choose these combinations for the majority of them.
Zachary Klaassen: That's great. LIBERTAS, as I mentioned at the beginning, such an important trial. It was great to discuss with you about the Latin American population. I know it's a busy meeting, thank you so much for taking time to join us on UroToday.
Andrea Juliana Gomes: Thank you, thank you very much.