NorthWest Biotherapeutics Inc (NWBO)

[ou71764]

re: DCVax-Direct. Is it possible for it to have a 80-100% response rate, with some patients having a complete response?

I looked at the Triozzi pilot study again. In their study a tumor had to have 50% shrinkage to be counted as having a response. 6 of 10 in the Triozzi study had at least 50% shrinkage. Another one had 25% shrinkage.

Further, one patient in the Triozzi study had a complete response - not just in the injected tumor, but with nearby tumors as well:

One patient (Patient 8) with melanoma manifested a complete response of the injected tumor and eight other 0.5–1.0 cm satellite lesions within a 6-cm radius of the injected tumor.

The current RECIST guidelines say that a tumor has to show 30% shrinkage for it to be considered a response. I am guessing that that's what the NWBO trial will use. Given that DCVax-Direct is an enhanced version of the vaccine used in the Triozzi study - and that the bar has been lowered to meet the threshold as having a response - then yes, it is possible that DCVax-Direct will hit a 80% response rate with some complete responses.

I won't go out on a limb to predict a 80% response rate. For me there are too many trial variables that I don't understand. Anyone (other than a research scientist) who looks at that write-up of the Triozzi pilot study has to admit that they don't fully understand everything that's in it. So the difference in the protocol between the pilot study and the NWBO trial isn't clear to me. Plus, I have no way of knowing how much better DCVax-Direct is than the vaccine used in the pilot study.

But yes, it is possible that there will be very big news from the DCVax-Direct trial.