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H2R

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Alias Born 07/17/2014

H2R

Re: None

Thursday, 05/12/2022 7:54:17 PM

Thursday, May 12, 2022 7:54:17 PM

Post# of 724274
Treatment arm 5 times better Control Group

The fourth secondary objective, OS, is overall survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.


See:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/GB#E

Taking the At Risk, not the KM curve (so not 13%) to make it clearer, and more conservative. Using the At Risk, not the KM for both, keeps the comparison fair. (Furthermore, The KM is better for both, but slide 30 shows 13% at 60 months while slide 40 does not have 60 months. Looking at the data extrapolate the KM graph is not precise. Hence this approach.)

The lost to follow up is about 2% in both the treatment arm and the control group of the DCVax trial, again, making the comparison fair (FYI, the external/historical group is at 5% ltfu).

How many survived at 5 years?

Treatment arm: 25 / 232 : 10.7 %
Control Arm: 2/99 : 2 %
* The 2 are the last survivors from the rGBM, assuming all patients who survived the recurrence in the placebo arm crossed over to be treated.

5 times better!
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