NorthWest Biotherapeutics Inc (NWBO)

[GermanCol]

PUTTING TO REST THE LIES SPREAD ABOUT NWBO PHASE III TRIAL - PART 3


Here is another analysis that makes me even happier and convinced of the success of NWBO Phase III Trial, that I want to share with you. This is part of the analyses developed to put to rest the lies spread about NWBO Phase 3 Trial, saying first that the results were going to be bad or not reported, that the delays were associated with bad results and then saying that the trail failed, that the “placebo” arm did better than the treatment arm and that interim results were better than the final.

As mentioned, none of this is true and actually the trial was a success as predicted.

Let me start with the following two tables I prepared based on the final results presentation just shared by the company. One is for Newly Diagnosed GBM Patients and the other for Recurrent GBM Patients

TABLE 1 - FINAL RESULTS NEWLY DIAGNOSED GBM PATIENTS



1. From slide 29 of 48 (Overall Survival in Newly Diagnosed GBM ). Total patients shown at the left bottom
2. From slide 36 of 48 (Newly Diagnosed GBM: MGMT Methylated). Total patients shown at the left bottom
3. From slide 37 of 48 (Newly Diagnosed GBM: MGMT Unmethylated). Total patients shown at the left bottom
4. Calculated as follows: 1 – 2 - 3 (232 minus 90 minus 131)

TABLE 2 - FINAL RESULTS RECURRENT GBM PATIENTS


1. From slide 39 of 48 (Overall Survival in Recurrent GBM) Total patients shown at the left bottom
2. Calculated from the numbers highlighted in yellow in the final row of the Figure below, taken from slide 21 of 48 (External Controls for rGBM – Patient Demographics and Prognostic Factors). These numbers are the percentages of Methylated (44%), Unmethylated (52%) and Missing (5%), adjusted for rounding and multiplied by 64, that is the total recurrent GBM patients (number 1 above).



Now, let’s continue with the following Table with the number of patients and percentages of Methylated, Unmethylated and Missing from the JTM publication:

TABLE 3 - INTERIM BLINDED BLENDED ANALYSIS - ALL PATIENTS



Finally, with all this information we obtain the following Table for the patients that never crossed over, so never received DCVax L:

TABLE 4 - FINAL RESULTS - NON CROSSOVER PATIENTS



1. Obtained as follows: MGMT Methylated from Table 3 (INTERIM BLINDED BLENDED ANALYSIS - ALL PATIENTS) minus MGMT Methylated from Table 1 (FINAL RESULTS NEWLY DIAGNOSED GBM PATIENTS) minus MGMT Methylated from Table 2 (FINAL RESULTS RECURRENT GBM PATIENTS). 131 – 90 – 28 = 13
2. Obtained as follows: MGMT Unmethylated from Table 3 (INTERIM BLINDED BLENDED ANALYSIS - ALL PATIENTS) minus MGMT Unmethylated from Table 1 (FINAL RESULTS NEWLY DIAGNOSED GBM PATIENTS) minus MGMT Unmethylated from Table 2 (FINAL RESULTS RECURRENT GBM PATIENTS). 162 – 131 – 33 = -2
3. Obtained as follows: Unknown MGMT from Table 3 (INTERIM BLINDED BLENDED ANALYSIS - ALL PATIENTS) minus Unknown MGMT from Table 1 (FINAL RESULTS NEWLY DIAGNOSED GBM PATIENTS) minus Unknown MGMT from Table 2 (FINAL RESULTS RECURRENT GBM PATIENTS). 38 – 11 – 3 = 24
4. Obtained as follows: Total from Table 3 (INTERIM BLINDED BLENDED ANALYSIS - ALL PATIENTS) minus Total from Table 1 (FINAL RESULTS NEWLY DIAGNOSED GBM PATIENTS) minus Total from Table 2 (FINAL RESULTS RECURRENT GBM PATIENTS). 331 – 232 – 64 = 35. As a confirmation for calculations, this same number is obtained by adding the numbers above: 13 – 2 + 24 = 35.

But don’t worry about the -2 MGMT Unmethylated obtained. This detail can be fixed as follows. From TABLE 3 - INTERIM BLINDED BLENDED ANALYSIS - ALL PATIENTS if we substract 2 patients from the unknown MGMT and add them to the MGM Unmethylated, the percentage of distribution between MGMT Methylated, MGMT UnMethylated and Unknown continue to be very similar to the ones in the 2018 JTM publication and perfectly 2 patients MGMT status could have been identified after 2018 publication.

With this, we obtain the table bellow:

TABLE 5 - INTERIM BLINDED BLENDED ANALYSIS - ALL PATIENTS - UPDATED


And using the same formulas above and the updated values in Table 5, we obtain the following values:

TABLE 6 - FINAL RESULTS - NON CROSSOVER PATIENTS - UPDATED


So here is the conclusion of all this analysis that I consider is huge for the success of the trial:

All of the patients with known MGMT gene promoter methylation status in the group of these 35 patients that never crossed over are MGMT methylated and that explains why these patients did better. This also expains why they are not comparable to the treatment arms for newly diagnosed and recurrent GBM. Out of the patients with still unknown MGMT gene promoter methylation status, almost all if not all are MGMT Methylated. With any kind of correct math we do, for more patients with unknow MGMT gene promoter methylation status that may have been identified after 2018 JTM publication, the conclusion is the same.




Sources:
JTM publication
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6
Final results presentation
https://virtualtrials.org/dcvax/dcvax.pdf

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.