I don't believe the data gives the complete story on life extension. Some patients living at the end of the trial period might live for many years, so the real benefit may be far better than the statistical one. Also, I believe that often after treatment is discontinued with a drug, because the cancer develops resistance to it, other drugs are found that work. In some cases, I believe drugs that a patient becomes refractory to actually work again after new drugs have been applied, and the cancer became refractory to them.
Personally I believe that alternating treatments even before a patient becomes refractory to the drug regimen they're on might be the way to deal with cancers that historically ultimately become refractory to SOC treatment. Decades ago when IMGN was testing Oncolysin's, while the cancer rapidly became refractory to the drug because it was a large molecule and not humanized, patients did see some benefit in using it, but the biggest benefit was probably that they were no longer refractory to the drugs they were on prior to going on the Oncolysin trial. IMGN had newer technology and abandoned the Oncolysin's, but it is possible the drug could have gained approval if tested in that manner. To my knowledge, no other drug is used this way, but that doesn't mean it couldn't happen.
Something else that I saw somewhere that backed up something I've been saying is that the Phase 2 data could be so good that the FDA determines the drug can be approved from it. I don't know that it will happen, but I saw a comparison where another drug achieved a 20% improvement, while ours is in the 60% range. I believe the other drug is continuing the trial. It's possible that combinations, like I mentioned above could keep people alive far longer, and this other new drug might do that, in spite of our drug extending life further. In fact, perhaps after treatment with our drug for many months, other drugs for months, it might be found that our drug once again works and can sustain life for many months again.
Gary |
