InvestorsHub Logo
icon url

Horseb4CarT

06/01/22 2:24 AM

#480404 RE: ccie1024 #480389

No worries!

Trials have defined endpoints and a statistical analysis plan (SAP) that lays out how the data collected during the trial will be analyzed and presented.

The DCVax L phase 3 trial has multiple endpoints, however the two primary endpoints are mOS ( mean overall survival) for nGBM (newly diagnosed GBM) and mOS for rGBM (recurrent GBM.)

There were some secondary endpoints that were not presented at the NYAS event, and I don’t remember what they were, however meeting the primary endpoints is success and overall survival is the gold standard endpoint for GBM since 5 year survival for nGBM has been less than 5%.

The results that were “previewed/presented” at the NYAS for the mOS are the results of the trial and both endpoints were met with high statistical significance, meaning the probability of the successful results being a fluke are extremely small.

Now the trial collected a treasure trove of data and it ran so long that there was at least 5 actual years of data even for the last participants and much longer for some, so the long and fat survival tail is actual, not extrapolated!

Hope that helped a bit.