Jianpeng Yu: Yeah, thank you so much.
Zachary Klaassen: So we have the POTOMAC trial that just got FDA approved two days ago. Durvalumab plus BCG in very high-risk non-muscle-invasive bladder cancer. And your work is looking at urinary tumor DNA and maybe deescalating immunotherapy for patients. What's the hypothesis behind deescalation of immunotherapy?
Jianpeng Yu: The systemic immunotherapy is a treatment option in high-risk NMIBC, non-muscle-invasive bladder cancer. But when we talk about one treatment or one therapeutic strategy, we usually think about three things. The first one is patient selection and the second one is when to start and the third one is when to stop. So we are thinking about the one to stop because in our current study, patients all have received the immuno systemic therapy and they all receive the complete response. So they usually ask one question, can we stop the treatment? Can we stop the systemic therapy? So the systemic therapy is very high financial burden and it has some side effects.
Zachary Klaassen: Absolutely.
Jianpeng Yu: So we think about when can we stop the systemic therapy? So the first question is we need an indicator. We need the biomarker. So the potential biomarker is very important. So that's a hypothesis from and the goal that we want to get and the indicator we want to get to get it over when to start, when to stop the systemic therapy.
Zachary Klaassen: Yeah, it's a great background. So tell us about the trial design or the study design for your guys' study that you presented at ASCO.
Jianpeng Yu: The study actually, it's a continuous study from another prospective which was two study. All the patients enrolled in this study received the complete response. All of them have the utDNA activity and some patients want to take the risk to stop the continuous long-term systemic therapy. They want to just try several cycle and do the discontinued therapy. So we think about this and we talk to the patients. Okay, they accept that then we have two cohorts. One is the short-term treatment and the other one is long-term treatment. And the short-term treatment, the design will be the patients will receive the additional three cycles and do the discontinuous treatment. And the long-term, they will follow the continuous long-term treatment. So that's a design. And we compare the outcomes, compare the treatment related toxicity and we see the results.
Zachary Klaassen: That's great. Tell us about the key results from your study.
Jianpeng Yu: Yeah. The key results is the patients, they receive the complete response with utDNA negativity and the outcome, the recurrence free survival, the overall survival, the duration of response in three years, they are comparable between the two groups, the short-term and the long-term. But there is a big question. Everybody knows that there is not a perfect therapy strategy.
Zachary Klaassen: That's right.
Jianpeng Yu: Yeah. So the long-term treatment will increase the high incidence of the grade three or more than grade three adverse events. So we cannot say that's a reason from the long-term treatment. We just see the creation. The long-term treatment is associated with the high risk to receive the worst adverse effects.
Zachary Klaassen: That's a great summary of the results. I think it's really interesting because now that we have options, who can we maybe offer a break for? How do you see this going into the clinic and how do we talk to patients about this?
Jianpeng Yu: This is very hard to talk. To make the decision, it's very hard.
Zachary Klaassen: Sure.
Jianpeng Yu: The patients, they know some background about the disease, but they're not doctors. We are doctors. We should know whether this will benefit for the patients. So we will think about more and talk a lot with the patients. And also the patient can decide what strategy they will have. We will respect the condition of the whole body.
Zachary Klaassen: Right.
Jianpeng Yu: Because some patients, the age, they are very old people, so we need to think about a lot of things. Also, we are confident with the utDNA detection. So we suggest that the utDNA could be indicated, but we don't have very strong evidence. So that's the reason we need to talk about with the patients and do a very complete assessment of the condition of the disease of each people to do the individual treatment strategy.
Zachary Klaassen: Great points. Dr. Yu, thank you so much for joining us. Any conclusions for our audience?
Jianpeng Yu: Yeah, our single center study, this is not very large sample size study, but we see some results. When people, they have a complete response and with utDNA detection negative activity, there will be some more effective, more important potential markers complete or can access the disease condition. I think with this indicator with the complete response we can try to do the escalation of the systemic therapy. Yeah, that's a conclusion and we will pursue this study and do more to see how it will be, how the results will be and how it will improve our therapeutic strategy.
Zachary Klaassen: Absolutely. Well summarized. Thank you so much for joining us on your-
Jianpeng Yu: Thank you. Thank you.