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Medicine Matters Oncology
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Medicine Matters oncology

I'm Shilpa Gutpa, I'm a genitourinary oncologist at the Cleveland Clinic in Cleveland, Ohio. I'll be giving a top-line overview of our trial BLASST-1, Bladder Cancer Signal Seeking Trial, which used nivolumab, gemcitabine, and cisplatin as neoadjuvant treatment in muscle-invasive bladder cancer patients.



We enrolled 41 patients on this study between February 2018 and June 2019. And our primary endpoint was pathological downstaging to less than pT2 at cystectomy. We allowed N1 patients to go on the study as well. And our statistical analysis was hypothesized to have primary endpoint of 55% pathological downstaging would mean it was a success. And we saw 66% pathological downstaging in our study, of which 49% were complete pathological CRs.



And this study was very encouraging in terms of efficacy as well as safety. There were no unusual safety signals found. There were no treatment related deaths. There were no significant immune-related events requiring steroids. And most importantly, there was no delay to surgery or any unusual surgical complications. And the plan is for the phase 3 study which is already ongoing, the ENERGIZE study, to look at this in a randomized fashion.



So NEO-BLADE study was presented by Dr. Syed Hussain. And this was also a neoadjuvant study for patients who are eligible to get cisplatin. And they randomized the patients to receive gemcitabine and cisplatin versus gemcitabine, cisplatin, plus a kinase inhibitor, nintedanib. And the other arm had a placebo.



Their primary endpoint was also pathological complete responses. Secondary endpoints for progression-free survival and overall survival. It appears that they did not meet the primary endpoint. However, they did see improvement in progression-free survival and overall survival, which was encouraging. However, it's not clear what the pathological CR miss contributed or what was leading to the OS and PFS benefit. But it was a very exciting study and we need more of such studies to look how we can improve upon the existing standards of gemcitabine cisplatin.



I think it's just a different target. The kinase inhibitors, you know, it affects FGFR which is an active target in bladder cancer. But patients were not selected for that. And immunotherapy, as we know, is active regardless of PD-L1 expression. So I think these are just two very different studies. And we are learning as we go.