Meghan McNamara: Yeah, so for our study, we first offer randomizing patients with regard to blue light or white light TURBT. And in addition to that, to better understand the blue light system, we have Convergent's UroAmp urine marker test that is utilized in conjunction with both the blue light cohort and the white light cohort pre-op and postoperative that allows there to be a genomic disease burden and to quantify what is the level of minimal residual disease compared to just from the surgical perspective of looking at when you're resecting the tumor, is there on a biologic level the difference and can we have a number on that scale and do the comparison that way? So that's the initial study design. And then also, following that up within the long term. So for our UroAmp collection specifically, doing it at points for standard of care, three months cystoscopy, 12 month, and 24 months to make sure that we're looking on a long term to quantify the recurrence free survival for patients in progression free survival as well.
Ashish Kamat: And then Armine, how do you think the results... Share with us the results, of course, but how do you think we can use this in actual clinical practice?
Armine Smith: Yeah, I mean, it's a great question. The interesting thing is the blue light has been available for quite some times, but its use is not very standardized. We know it detects more cancer, especially patients with CIS, but in de novo patients or the mixed study populations, it hasn't really shown very consistent results. So I think this is the study, so there is definitely a role for randomized study like that. What we're trying to figure out with the studies, if this additional detection helps us resect better in the de novo tumors, the TURBT patients, and if this is actually translating into meaningful clinical results. And I think that's the question we've been missing this whole time, right?
We all know that really good TURBT is paramount to good treatment of NMIBC, non-muscle invasive bladder cancer, but so far we've only relied on visual correction. We do this, we see the tumor is gone, we're happy. What this study also does, it just links this visual anatomic resection with some more biological responses such as this minimal residual disease that is assessed by the UroAmp testing. And the UroAmp testing looks at a level of urinary tumor DNA based on 60 genes. It's a newcomer in the field, quite exciting. It looks at the types of the genes that are mutated potentially, more personalized approach, and helps us probably quantify in the future of escalating versus deescalating the therapy. So I think this is merging both blue light technology with some biological responses that are measured by minimal residual disease from UroAmp.
Ashish Kamat: And the field is moving to bladder preservation even after neoadjuvant therapy, right? Because I mean, clearly we have the data from the EV/pembro study, from the NIAGARA study and phenomenal path response rates. And I think the next phase of the studies that are ongoing is to how to assess clinical complete response and how to have that clinical complete response then correlate with pathologic complete response. Do you think what you are proposing here is something that would be able to be translated into that arena?
Armine Smith: Absolutely. I think we do need better measures of the complete response. We know that what we have right now, it's not perfect because we still miss about up to 50% of residual tumors after these responses. So urinary tumor DNA is going to be very important in the future when it's validated more. Better resection methods, better detection methods such as blue light will be important. And then I think since we're going into this era of more therapies, expensive therapies, it's important also to substratify the patients who needs more therapy, less therapy, more or less surveillance, maybe deescalating care, maybe escalating. These are all the questions we're hoping to start answering little by little.
Ashish Kamat: Yeah. I think I always say no patients should get more treatment than they need or not more than they deserve. We have to really personalize it to the patients, and you don't want to have too much treatment or too little treatment. I think one of the things with the whole blue light paradigm has been it might be detecting more tumors, we know it does. How relevant are those cancers? So how do you think that this might help answer that?
Meghan McNamara: I think looking specifically from the UroAmp aspect and the urinary tumor aspect, it allows us to have that biological information that is not visualized. So if it's a very small tumor for instance, or something that's not picked up readily by blue light or white light, then we have additional metric that can be utilized by discretion of the physician. So it's not just one data point per se. You have multiple data points and I think from a patient perspective as well, we've seen a lot of great feedback where patients are very interested in the genetic making of this tumor and what are the 60 genes that are being validated and is there a risk stratification score for them in the future. I think a twofold aspect from the physician scientist angle of looking at clinical care, but also from a patient perspective that they can have additional information, additional metrics for the future for their care as well.
Ashish Kamat: Excellent. Excellent point that you made there. In closing, what's the bottom line message or message you want to share with our audience about the study?
Armine Smith: Like you said, I think no patients should get more therapy or less therapy that they need, and this is really a step towards personalization of the treatment for the patients. Using a two-prong approach of more potentially better resection and newer methodology such as a urinary tumor detection and things of that nature would be very helpful.
Ashish Kamat: Great point. And I hear that after being mentored by a wonderful mentor, you are now going to medical school, so congratulations.
Meghan McNamara: Yes, thank you. Yes. I had a phenomenal mentor that not only taught me from the patient perspective of to listen and to understand, but also taking what you're hearing in the clinic and translating that over into research that's actionable, so it's been a wonderful opportunity to work with Dr. Smith.
Ashish Kamat: Great. You can thank her.
Armine Smith: Thank you.
Meghan McNamara: Thank you. Thanks.
Ashish Kamat: That's sweet. Thank you so much.
Meghan McNamara: Thank you.
Armine Smith: Thank you.