The entire reason the trial was extended for so long was precisely because of this. This is not news, but it IS giving us the official final word instead of speculation (if anyone was still speculating they were not very well in the know in my opinion). During the early phase of the P3 they were having more Progression in the treatment arm than they expected, yet they were also seeing that everyone was living longer than expected. Most people die 1-2 months after progressing. So, if people on treatment were “Progressing” but living much longer, statistically significantly longer, then something wasn’t jibing with the “Progression”. When they looked again at the MRI that suggested “Progression” in those that survived longer than expected, then did another MRI, they found the “Progression” had disappeared. Radiologists who read MRIs for Cancer Clinical Trials have criteria by which they call Progression vs. Pseudo-Progression and they’re familiar with what the edema from Pseud-Progression looks like from Radiation Therapy. What they didn’t know was that the Pseudo-Progression from edema from DCVax looked very different from that of Radiation. So they thought it was real.
So, what does one do when the trial is showing people are living longer than expected but the trial endpoints were set during a time when this stuff wasn’t understood/known? You’re allowed to change things in a clinical trial when new information and new standards become clear. People who say you can’t are just trying to confuse people and make the water muddy when it’s not. The problem was that there were so many moving parts happening at the same time it took time to figure it out while they allowed the data to mature. This is the clearest blinded trial ever in the history of trials I’d bet. The fact that it’s so safe, and that it’s going to be one of, if not THE, cheapest and most effective therapies for GBM is a huge breakthrough. You DO NOT throw out a trial of this magnitude when you see people are living beyond any reasonable expectation; you find a way to analyze the data that proves what you’re seeing with your own eyes. This is not difficult to understand and it’s certainly not hard to see this will be approved. The UK is pulling the company to them. If the FDA screws around at all American patients will lose their collective shit. I don’t anticipate a problem from the FDA however.
