My thought had been that if in fact the tumor had morphed, or the new tumor was in some way different from the original, wouldn't what's extracted from the blood be somewhat different. I have no expertise, but it was my thought that the vaccine established resistance to the tumor from the specifics it got from the blood.
Many years ago IMGN had drugs called Oncolysin's, they were conjugated with blocked ricin which was a rather large molecule. The trial gave the drug to patients refractory to the SOC. The result was that while some benefit was seen, after a few doses patients became refractory to the drug. In reality there was a benefit which wasn't pursued, in becoming resistant to the Oncolysin, the cancer was found to no longer be refractory to the SOC and treatment was resumed. I don't know if this cycle could have been repeated many times, but no attempt was made to try it that way. Perhaps part of the thinking was that it wouldn't be a profitable product in this way, and the cost of such an approval would be very high.
Generally the FDA wants drugs that are better than the SOC. The idea that by attacking a cancer briefly with something different would extend the duration of successfully treating with the SOC is something that would require a totally different mindset from the FDA as well as drug developers. I'm no expert, but I suspect that alternating treatment for cancer to prevent the cancer from becoming refractory to a drug might permit treatment to be extended indefinitely. The question might be, do you wait for an indication of the cancer becoming refractory, or change the treatment on some schedule that's intended to prevent it. I don't know the answers, but like to ask such questions.
Frankly, if the FDA only approves drugs which are an improvement on the SOC, wouldn't it seem logical to remove the approval from the older product, making the new product the SOC. I'm not advocating that, I believe there are good uses for all these products, but if you agree with that, why not also approve drugs that show benefits, but don't surpass the SOC. I'd contend that these drugs too would give Doctors more tools to work with, and in some cases could prove to be the answer for certain patients. The big thing would be if cancers could be prevented from becoming refractory to one product by alternating with others, might that not become the SOC even if one product could be used substantially longer than the other.
Years ago I met a gentleman at a pancreatic cancer conference I attended because of a drug being discussed there. This man had pancreatic cancer for over 5 years without the Whipple procedure. His longevity was attributed to his Oncologist. Each time his Oncologist said he'd tried everything he could think of and couldn't stop the cancer from advancing he found a new Oncologist. He certainly didn't limit his treatment to the SOC, he'd try anything, and it was keeping him alive.
I believe that people treated for all sorts of cancers is improved because Doctors have learned to experiment more when cancers are no longer responding to the SOC. I seriously doubt that any approved product is purely used in the manner in which it was approved, I.E. with only the protocol specified in the clinical trial. If the FDA changed to approve drugs based on the idea of not doing harm, but approving drugs that achieved some benefit, I suspect patients would live much longer even if the benefit wasn't as great as the SOC.
Gary
