Missing biomarkers in MNCA trialDr. Ashish Kamat's study that evaluated the use of cytokine markers to predict response to BCG and identify NMIBC patients at risk of recurrence was completed between 2005 and 2009. Results from the study were epub-ed last July and the paper has just come out in this month's issue of European Urology (the link is below). As Dr. Kamat was also the senior author on the MCNA paper (which accrued patients between 2006-2011), I wonder why the MCNA study design didn't also include collection of urine samples before and after MCNA installations (as had been done for the earlier study with BCG). There is no mention in the MCNA paper of urine (or blood) sample collection at any point during the phase III trial (which from my personal perspective as someone with 30+ years experience with clinical trials in immunology/autoimmunity, would be very unusual). In fact, the lack of any biomarker studies for MCNA was highlighted as a weakness in Telesta's presentation at the FDA AdComm. The inclusion of any data on changes in cytokine levels (that identified patients as responders and/or at risk of recurrence) related to MCNA use might not only have bolstered the case for MCNA but also been very informative when compared to the results with BCG. The same multiplex cytokine testing platform by Alere could have been used in the MCNA trial so the results would have been directly comparable. I have no idea why this wasn't done. My hope is that perhaps it was done but results have not yet been released. I have no reason to believe this is the case, but I can't understand why the study wouldn't have included urine sample collection. Especially given Dr. Kamat's involvement in both studies and the importance he placed on the measurement of biomarkers for NMIBC. Here is the link to the recent paper: https://www.europeanurology.com/article/S0302-2838(15)00526-6/fulltext/cytokine-panel-for-response-to-intravesical-therapy-cyprit-nomogram-of-changes-in-urinary-cytokine-levels-predicts-patient-response-to-bacillus-calmette-guerin