NorthWest Biotherapeutics Inc (NWBO)

[GermanCol]

I think it's time to put to rest all the lies that have been spread, saying that the trail failed, that the “placebo” arm did better than the treatment arm and that interim results were better than the final. None of this is true and actually the trial was a success as predicted.

Based on the final results presentation shared this week by the company (https://virtualtrials.org/dcvax/dcvax.pdf) I prepared the following chart. In order to compare the final treatment arm results with the interim blended blinded data reported in 2018, the survival points for 12, 24, 36 and 46.5 months from surgery were located in this chart. These points were located at 8.9 (12 minus 3.1) months, 20.9 (24 minus 3.1) months, 32.9 (36 minus 3.1) months and 43.4 (46.5 minus 3.1) months because the 2018 interim blended results were measured from surgery, the final results were measured from randomization and the average time difference between surgery and randomization was 3.1 months.




The following table contains a comparison between the final results of the treatment arm for the newly diagnosed GBM (shown in the chart above) and the 2018 interim blended blinded results shared by the company:



* From:
- JTM interim results publication. https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6
- Press Release November 19, 2018 https://nwbio.com/updated-interim-data-from-phase-3-trial-of-dcvax-l-for-glioblastoma/

** Calculated from JTM interim results publication:
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6

As of this analysis, 223 patients are>=30 months past their surgery date; 67 of these (30.0%) have lived>=30 months and have a Kaplan-Meier (KM)-derived mOS of 46.5 months.

This means that at 46.5 months, 15% (30% / 2) of those patients were expected to be alive.

As a conclusion from this table:

-At 12 months from surgery treatment arm final results were better than blended blinded interim results (91% vs. 89.3%)
-At 24 months from surgery blended blinded interim results were better than treatment arm final results (46.2% vs. 45.5%)
-At 36 months from surgery treatment arm final results were better than blended blinded interim results (26% vs. 25.4%)
-At 46.5 months from surgery treatment arm final results were better than blended blinded interim results (16.5% vs. 15%)

So, for 3 of the 4 points in the table, the final results were better than the results for interim blended blinded results shared in my analysis previous to final results release (https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168777187) and just for 1 of them they were better for the interim blended blinded analysis.

And the reason for this is actually good news because this can be explained as follows. At the beginning, the treatment arm started to do better because of DCVaxL, then as progression and pseudo progression (confounding factor) started, patients were taken out of the treatment arm and of the “placebo arm” to start going into the recurrent GBM treatment arm. So the already dead patients started to have higher effect in the treatment arm because there were less patients at risk. Also, important to take into account when analyzing this effect that recurrent GBM treatment arm is measured from recurrence, not from randomization or surgery. Then, after that, with the long term positive effect of DCVax, which is higher for patients that started earlier with the treatment, the treatment arm patients continued doing better and not only counteracted the effect mentioned of having less at risk (that is just a mathematical effect), but also continued doing better and better than what was shown in the interim blended blinded results.

Other very important point to mention is that it was actually very good news that there was no higher separation between the arm for newly diagnosed GBM and the “placebo”, which we know is not a placebo arm. It’s basically the opposite from a placebo arm, it is mainly composed by the treatment arm for recurring GBM. So if it would have been a higher separation between them, GBM arm would have been even better, but recurrent GBM arm would not have been as good as it is.

And here comes the best part. From the presentation: “GBM Is a Particularly Difficult Cancer” “Nearly 100% recurrence rate”, so is even more important to have it approved for recurrent than it is for newly diagnosed GBM and with such a benefit it showed. And that makes even better if the previous OS endpoint was not met because it would have meant bad results for recurrent GBM. Mathematically we can’t have the three endpoints positive at the same time. Maximum 2. Which ones we prefer, we got the best possible for the value of the company

Disclosures: English is not my native language, so sorry if you find mistakes in wording or redaction. This is not investment advice, I am sharing my analysis and opinion based on public information.