NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

This trial's true winners are the 64 controls who after progression crossed over I am estimating their mOS after randomization at 24-25 months which is much higher than the 19.3 months mOS for Treatment patients cited in Dr. Mulholland's presentation.
In calculating this I have made the assumption that the very small group of 35 true placebos who never crossed over had an mOS of about 16.5 months which would be equivalent to the mOS of the external controls of this trial. That is the only estimate that I made because the rest of the calculations are based on the established data in the May 10 presentation.
Now the 232 Treatment patients with an mOS of 19.3 months after randomization lived a total of 4478 months (232X19.3=4,477.6 months) and the 35 true placebos lived a total of 578 months (35X16.5= 578 months). The total number of months lived by the combined group of 267 patients ( 232 Treatment and 35 true placebos) was 5056 months (4478+578=5056 months) and the average mOS of that combined group of 267 patients is therefore 18.9 months (5056 months/267 patients=18.9 months per patient).
The 2018 JTM paper and the 2018 SNO update both stated that the mOS of the entire trial (331 patients) was 23.1 months after surgery and therefore about 20.0 months after randomization.
That would mean that the 331 patients lived a total of 6620 months (20monthsX331 patients=6620 months). Since 5056 months of life were consumed by the combined group of 267 patients (232 Treatment and 35 true Placebos), the remaining 1564 months (6620-5056=1564 months) must have been lived by the group of 64 crossover patients. That mean that the mOS of the crossover patients was about 24.4 months (1564/64=24.43 months).
If the calculations are correct, the crossover group had an 8 months mOS advantage over the external controls and more than a 5 months mOS advantage over the Treatment group (early DCVax-L recipients).
Just wondering how many 3 and post 5 year survivors originated from that crossover group.
A question relating to the performance of the crossover group: Why did the UCLA combo trial elect to test DCVax-L obtained from recurrent GBM patients because those recurrent patients often cannot be subject to surgery and tumor preparation? Why were instead nGBM patients not selected for the combo trial? Almost all nGBM patients can undergo surgery and a vaccine can frequently be prepared from the initial tumor of those patients.
Perhaps the UCLA combo trial personnel already knew that recurrent GBM patients respond extra well to the vaccine especially when that vaccine is prepared from the mesenchymal antigen rich recurrent tumors.