AI
Thursday, April 22, 2021 11:36:22 PM
I have updated my Table that compares the DCVax-L Phase III clinical trial 2018 interim results, to reflect the exact same 5 External Control Arms (ECAs) that Dr. Linda Liau used in her presentation at the University of Utah on April 9, 2021.
After reviewing the clinical trial results from these 5 ECAs, and reviewing each ECA study design, there are 2 primary variables that we have to consider when we compare the results of each ECA to the DCVax-L blinded & blended interim results:
1. When were patients randomized in each clinical trial?
2. At what starting point was Overall Survival measured from?
After a thorough review, there are some very important facts that we should note:
1. There is not a 3-month randomization timing difference between the DCVax-L trial and the other 5 ECAs. There is no need to shift the DCVax-L curve over 3 months.
2. At most, the OS measurement timing difference is only 6 weeks (1.5 months), and for the Gilbert et. al. 2014 trial, the timing difference is only 3 weeks.
3. The DCVax-L OS of 23.1 months is for the blinded & blended ITT results, the unblinded & unblended DCVax-L results will be better, IMO between 27 and 30 months.
The bottom line is, the DCVax-L interim results are a "giant leap forward" and represent a significant improvement in a treatment option for newly diagnosed and recurrent GBM patients, compared to the current standard of care (SOC).
After reviewing the clinical trial results from these 5 ECAs, and reviewing each ECA study design, there are 2 primary variables that we have to consider when we compare the results of each ECA to the DCVax-L blinded & blended interim results:
1. When were patients randomized in each clinical trial?
2. At what starting point was Overall Survival measured from?
After a thorough review, there are some very important facts that we should note:
1. There is not a 3-month randomization timing difference between the DCVax-L trial and the other 5 ECAs. There is no need to shift the DCVax-L curve over 3 months.
2. At most, the OS measurement timing difference is only 6 weeks (1.5 months), and for the Gilbert et. al. 2014 trial, the timing difference is only 3 weeks.
3. The DCVax-L OS of 23.1 months is for the blinded & blended ITT results, the unblinded & unblended DCVax-L results will be better, IMO between 27 and 30 months.
The bottom line is, the DCVax-L interim results are a "giant leap forward" and represent a significant improvement in a treatment option for newly diagnosed and recurrent GBM patients, compared to the current standard of care (SOC).
