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Sunday, July 14, 2024 2:02:44 PM
Once the trial effectively became single arm, and with no ECA patient level characteristic similarities, the trial was compromised. Do not discount the screening selection of only the "healthiest" patients in order provide enough time for L to kick in and to monitor for PFS.
BS. While the inclusion/exclusion criteria of the DCVax-L trial may
have been somewhat different from those employed by the ECAs,
the results demonstrate that the mOS of the trial patients would not
have been significantly different had none of them received DCVax-L.
This is clearly shown by the fact that the mOS of the unmethylated GBM
Treatment patients (16.9 months) was not significantly different than the mOS
of the ECA's unmethylated GBM patients (16.5 months). Furthermore, over 6%
of the unmethylated GBM trial patients survived more than 5 years whereas
there was no record of any of the more numerous ECA's unmethylated GBM
patients living that long. This suggests that the beneficial effect of DCVax-L
may have somewhat increased the survival of many shorter living unmethylated
GBM treatment patients and had those patients not received DCVax-L, their
mOS would have been even shorter than 16.9 months.
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