Just a slightly different perspective.
Even though there is currently a trial for a combination using DCVax-l as the SOC, remember, and this is a slight different way of looking at this, Dr. Pazdur wants commercial mass production of incoming (new) SOC therapies not only to treat patients equitably around the world, but he also wants a manufacturing capability to churn out enough new validated and consistent product in order that large international trials can be conducted.
Having DCVAx-l monotherapy as the standard of care for recurrent GBM provides a reliable and safe comparator that researchers already strongly suspect can be improved upon with a three product combination. DC + CI + CSF1R.
They’ve known this for at least 6 years but have been able to do little about it, because the commercial SOC has/is taken so long to get to market. They have one trial, DC + CI for rGBM, but they already know it will need to be improved upon by also adding CSF1R.
So all these lined up potential cures for people, Aka combination, DCVax-Direct
and hyperactive DCs, are awaiting a base commercial manufacturing market for DCVax-l.
A short cut???
Parallel to Dr. Pazdur’s position that a ramping global SOC must be available, other professionals believe ECA arms can replace or at least bolster therapy development in the future.
However, if DCVax-l is the therapeutic SOC, its RWD and Phase III data will be utilized. In either case, DCVax-l will need to have built up enough data from which to draw comparisons for trials of combinations and other therapies.
I liken the current situation to ships with grain ready to traverse to their destination but instead sit en masse waiting for the OK from higher up.
It’s repulsive how long this is taking, as patients literally die while technology tries to set up a new system that can globally distribute, treat and, beyond that, test for better combinations and other alternatives.
We have to believe everyone is doing their best, but one can’t help sense that the trappings of a material and bureaucratic world slowed this process down at various turns.
Even public advocates have material self sustaining concerns that potentially distract from their mission to push and support.
Here’s hoping this redirected ship avoids the rocks and moves our painfully slow progress toward a more efficient paradigm and open water.
