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Monday, April 14, 2025 2:03:23 AM
They hid the fact that they needed to run the trial longer as they did not expect it to be effective as previously assumed.
Another way of looking at it was that DCVax-L was so effective that it caused the immune cells to race to attack the tumor, causing inflammation and swelling, thus mistakenly being diagnosed as tumor progression when instead, it’s tumor pseudoprogression… resulting in a compromised treatment arm designed to prove the previous primary endpoint - progression free survival (PFS). So now the company had to turn to the secondary (and confirmatory) endpoint of the trial (now the primary endpoint) to prove “efficacy”.
As Linda Liau told us in 2015, everyone in the trial was living longer, and that sounds like efficacy to me. It just took a longer time to prove.
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