NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

And what is even more interesting Idunno is that at 12 months from randomization, the survival percentage of the group of 99 placebos is almost identical to the percent surviving in the treatment group and that despite the fact that all members of the treatment group received DCvax-L already right after randomization. In contrast, 35 of the 99 placebos were never treated with DCVax-L and of the 64 patients who received DCVax-L before the 12th months, most received the treatment only a few months earlier, too early to have an effect on the number of 12 months survivors. I believe the explanation for that is simple. In both the treatment and placebo groups, about 1/3 of the patients are less robust and deteriorate relatively rapidly. Such patients do not respond to DCVax-L when administered after randomization or after progression.

The calculation is as follows: According to the OS curve of the 2018 JTM (fig2), about 255 patients of 331 or 77.0% were still alive at 12 months from randomization (15.1 months from surgery). According to the NYAS presentation,
178 of 232 treatment patients (76.7%) were alive at 12 months. Therefore, 77 of the 99 placebos (77.8%) were also alive at that time (255-178=77).
Clearly, the percent survival in the two groups is very similar and at that point early treatment shows no advantage over the crossover treatment.

The 24 month timeline is even more mind boggling. The 2018 JTM data shows that at 24 months, about 132 of the 331 patients (39.9%) were alive whereas per the NYAS presentation, 81 of the 232 treatment patients (34.9%) were post 24 months survivors. Therefore, 51 of the 99 placebos (51.5%) were also alive at 24 months (132-81=51). I have estimated that almost all of the 24 months survivors are crossover patients. I am ready to verify this if challenged.

We have to wait for the JA to see what the survival stats will be for the treatment and crossover groups at 36, 48 and 60 months, but up to 24 months, the crossovers hold a distinct edge. My question now is this: Will the results show that it is better to initiate the DCVax-L treatment early, or is treatment after progression a better option? Late treatment may have an advantage in some cases where a resection of the secondary tumor can be carried out and can be used for preparation of even a better, more homologous vaccine.