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Thursday, June 25, 2020 9:05:29 PM
There is so much to unpack to answer your questions.
Are you sure that she said progression and pseudo-progression would muddy the waters of the control arm? Because to my thinking, pseudo-progression caused by chemo/rad (if it were even the case) would effect both arms, and therefore, not really muddy either arm.
But if pseudo-progression were caused by DCVax-L, as many of us think, then it would be muddying up the treatment arm. Obviously, if the treatment arm were to demonstrate an immune response that appeared like progression, and PFS were the end point being measured, you'd likely see more treatment patients progressing, and crossing over to treatment (either again, or for the first time)... then one would want, or expected to see in this trial.
Still... yes, if something like this turns out to be the case, and I suspect we'll find there was an issue with pseudo-progression and that it did "wreak havoc" on our trial, then extending the study out to show the long tail of the OS endpoint has indeed been the way to move forward with the trial and to address this issue.
And we should note, there were about 33 control patients who never were treated with DCVax-L in this trial. Admittedly, that is a small number, however their results will be counted with the control arm, and there's a unlikely possibility they could comprise there own data set as well.
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