RE:RE:RE:RE:Bored. Waiting. Here is some playing with data to look at. Very interesting Dawg .That puts Ruvidar in an even stronger position than Adstiladrin as a treatment for NMIBC..
According to Theralase we are looking at a BCG-unresponsive NMIBC market of 9,251 patients per year.
If all of those patients were treated with Ruvidar and 40% achieved CR that would mean 3,700 patients who were headed for cystectomy would be able to keep their bladders.
If all 9,251 chose to be treated with Adstiladri only 1,850 bladders would be saved.
So choosing Ruvidar over Adstiladrin would result in 1,850 more patients a year cured of bladder cancer.
DJDawg wrote: Great post Eog.
The one thing that always bothers me about immunotherapy is how to quantify whether the benefit from the drug amounts to a cure and removal of all residual cancer cells vs the idea that the immune system is actively working on the cancer cells and keeping them below the threshold for cytology and cystoscopy to see the cancer present.
With adstiladrin, based on the published data, you keep losing patients at a steady rate for every interval. So being CR with an immunotherapy agent doesn't mean the same thing as being CR 6 months out from Ruvidar. For adstiladrin, you would have gotten another whack-a-mole treatment at 3m to keep the cancer cell count down.
Then at 12m, you are 6m out from your last ruvidar but you are only 3m out from your last adstiladrin.
In essence, if you are CR and you keeping getting frequent treatments, are you really CR in a way that compares to someone who is CR at 12m after getting only 2 treatments of Ruvidar (0,6m).
Of course, what matters most is what FDA thinks. I'm kind of surprised that Dr. Shore thinks that 20% at 24 m is good. Seems like a low bar to say that for every 5 patients who go through it only 1 is CR at 24m. With Ruvidar, that would be more comparable to 5 patients and 2 are CR at the end.