NorthWest Biotherapeutics Inc (NWBO)

[alphapuppy]

DCVax-L GBM trial Result PFS Model based on IMUC Control DATA

Reposted now with updated working links.

Discloser: I am long this stock; I have no inside information; I am a clinical researcher.

Hypothesis 1: The Control Patients in the DCVax-L GBM trial should relapse at a rate similar to what was shown in the IMUC trial. The IMUC trial is the most similar to the DCVax-L GBM trial in terms of eligibility entry criteria. The progression free survival (PFS) was reported recently at the 2014 American Society of Clinical Oncology (ASCO) meeting.

https://www.dropbox.com/s/a90hj1507dd2ekr/bosch%20nwbo%203.PNG?dl=0

Hypothesis 2: Given that we know the number of PFS events in the total DCVax-L trial at this time (first interim analysis) is 66 December 2013;

https://www.dropbox.com/s/qy0zlxwehjf5f9l/nwbo%2066%20events.JPG?dl=0

And NWBO reported 248 PFS events on before 2/1/2017

https://www.dropbox.com/s/w60sbgacpzi28ck/bosch%20nwbo%201.PNG?dl=0

Then one can model using JMP(SAS) software, model the control arm PFS for the DCVaX-L trial to be the same as the corrected IMUC trial results and thus obtain an estimate of the probable number of events required in the control arm of the DCVax-L. When one does this with a Kaplan Meier plot, one obtains a result of 100 events in the control arm with the total number of patients in the control arm of 111. Then one can deduce that the number of events in the experimental arm for the DCVax-L trial would be 331- 111 or 148 events.

Hypothesis 3: Using the derived 148 PFS events in the experimental arm, one can model the experimental arm to be similar to the IMUC control arm trial results but, in this case only allow for just 148 events out of 220 total patients in the DCVax-L experimental arm.
When one does this with a Kaplan Meier plot, the data and curves are shown below. When one applies log-rank and Wilcoxon significance testing to the two curves one obtains a significant result of p<.0001

https://www.dropbox.com/s/o6270dlwrcx3wr8/PFS%20NWBO%20COMPARE%20jpg.JPG?dl=0

My best-educated hypothesis is that clearly, the DCVax-L trial is going to return a positive result on the primary end point

This result will be a practice changing result. Especially when one sees the plateau in the treatment curve. The nice thing about this PFS review also is that there is no crossover effect between the curves such as could occur with my prior overall survival analysis OS.
129619 Alphapuppy Ihub post
Just to put this into perspective the Stupp GMB trial PFS only increased 2 months by the addition of temazolamide (TMZ) (5 to 6.9 months). Yet this became almost immediately, the new gold standard of care in this disease and TMZ almost immediately became a blockbuster multi-billion dollar drug.

DCVaX-L increases in the operable patients even more than this and with none of the chemotherapy side effects and will quickly be the new standard of care in this disease.