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FeMike

09/15/22 5:38 PM

#514215 RE: meirluc #514212

Excellent post, very relevant.

PFS didn’t fail. The ability to identify PFS failed.
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dr_lowenstein

09/15/22 5:38 PM

#514218 RE: meirluc #514212

That is what we scientists call bullshit
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jondoeuk

09/15/22 7:15 PM

#514258 RE: meirluc #514212

This trial did not fail to meet PFS, the original primary endpoint because it became clear during the trial, that PFS, a surrogate of OS, has failed miserably as an adequate endpoint in this trial and is most likely an unsuitable endpoint for other immunotherapeutic trials.



Looking at progression-free survival, the hazard ratio was 1.1. So those in the vaccine arm did worse than placebo. They didn't report the hazard ratio for overall survival, but the blended median overall survival was 23.1 months for placebo, while for the vaccine it was 22.4 months. Again, the vaccine did worse than placebo. So, the trend was to harm, not benefit. Or put simply, the trial failed.