Eoganacht wrote: I think what happens is, when you have a new treatment which is for a very time sensitive disease you go to the back of the line. It is very important that high-risk NMIBC is treated effectively before it advances to MBIC. Half of all patients with non-metastatic MIBC will not survive 5 years.The most effective treatment seems to be radical cystectomy (5 year survival rate of 54% - 68%) but if you wait too long and the cancer metastasizes.to distant parts of the body the 5 year survival rate is only 8%.
40% of patients with NMIBC will fail BCG treatment. The group of patients with high-risk NMIBC who fail BCG.comprises the population our current trial is aiming to treat. The standard of care treatment for these patients is radical cystectomy as it is seen as their best long term chance of survival. Those who refuse to have their bladder removed or are not suitable for the operation are the candidates for our trial.
So the treatments for this segment of the bladder cancer population (high-risk BCG-unresponsive) are attempting to save as many patient lives as possible without having to remove their bladders. For all it's faults, Keytruda has given hope (at one year) to 19.4% of this group, Adstiladrin has managed 24% and Ruvidar will likely be 40% or more. The goal would be to provide a treatment that makes radical cystectomy unnecessary, but that would mean beating their 54% - 68% 5 year survival rate,
Once Ruvidar has proven to be the best BCG-unresponsive treatment this would lower the risk to the 60% of NMIBC patients who will respond effectively to BCG if they were to forgo BCG treatment and try Ruvidar pdt instead. There is an ethical issue in using an untried treatment as a first line treatment on a patient population when an effective treatment is already available and delay could cost them their lives.
With low-grade NMIBC, BCG failure means a risk of recurrence but not likely progression. Ruvidar PDT migt be an easier sell as a first line candidate for those patients as the risk of delaying BCG treatment is not as high.
Legit62 wrote: Great point, why wait to use it as last response treatment and put patients through all the other treatments first, maybe some day that will be the case when a big pharma with the money owns us