Replies to post #374118 on NorthWest Biotherapeutics Inc (NWBO)

[j e d]

DCVax’s selection criteria is on par with all other GBM trials, and seems to be faring better. All clinical trials whittle their patients down from the general pool, and NWBO’s is extremely similar to comparators based on age, methylated status, etc—and yes, REP. If you think their selection criteria is nefarious, go ahead and compare it to other recent GBM trials. You’ll see little difference. And yet, DCVax blended data is better than the pack. That seems to be consistent with... hmm.

[Doc logic]

AVII77,

Low absolute lymphocyte count patients, expected to have poorer outcomes, were allowed into this trial in Germany and yet maturing data which included the German patients suggested an improvement in longer term outcomes was occurring and some of these patients were included in the 100 best survivors category being looked at for long term survivors. If low ALC patients were responding well to treatment while low ALC SOC/placebo patients were eventing early as expected an ethical issue for the Germans would have arisen if a statistical analysis was used to prove this out. Funny that Fraunhofer claimed to only enroll to the point statistically necessary and then never gave enrollment numbers even though all planned for treatment patients were enrolled while 17 SOC/placebo patients were left out even though 31-32 patients were enrolled after the screening halt. Best wishes.

[j e d]

your stats also only pertain to median survival, and do not address the extremely high 3, 4, and 5 year survival data

[RuleofK]

AVII77
“The DCVax trial randomized 331 out of 962 GBM patients they considered.
The majority of those excluded were for the reason of disease progression. “


https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-018-1507-6/figures/1

Not to sure about your claim.

Just saw you’re comments on this. But still yet only 250 excluded due to progression. Not sure that would be “most”. Roughly 1 out of 5.

[MI Dendream]

Are you familiar with the term ‘red herring’?

General population data is irrelevant when similar trial (i.e., similar entrance and exclusion criteria) placebo data is available as contemporaneous comparison which it is.

[longfellow95]

The DCVax trial randomized 331 out of 962 GBM patients they considered.

Ok. Seeing as the rest of your post is predicated on the above stat that you quote, where did you get your figures from?

If you can't adequately evidence the stat, then the rest of the post pretty much falls by the wayside.

[sentiment_stocks]

Unfortunately the paper you reference in your post, “Rapid Early Tumor Progression is Prognostic in Glioblastoma Patients”, is behind a pay wall so isn’t fully available for most of us to review.

https://pubmed.ncbi.nlm.nih.gov/30973372/

One should note, however, that the snapshot in the link you provided indicated that it involved a total of 87 patients, 52% of which were (rapid early progressors) REP. That means the sample that you cite for comparison of the mOS of the unmethylated and methylated (19.6 and 34.7) is for a fairly small sampling of only 42 patients. And because of the pay wall, the link you provided prevents us from seeing what was the entry criteria for this group.

So while the consistence between the medians of these 42 methylated and unmethylated GBM patients is similar to the blended medians of the DCVax-L trial for methylated and unmethylated, it’s also a small sample without any other comparable criteria to show other than the meth status and that these patients had GBM.

Additionally, while most of us agree that medians are helpful as a comparative measure, you know full well that medians are not what the DCVax-L trial will be measuring, but rather the entire measure of the treatment arm’s overall survival, and of course, as it compares to the entire measure of overall survival of control arms in other contemporaneous, AND COMPARABLE trials.

And while you may find this type of ECT comparison objectionable, it appears that the SAB, the steering committee, the multitudes of primary investigators, Northwest management are all prepared to utilize them to file BLAs with the RAs, despite your objection.

So I’m sorry that while you may find a 25% chance of living five years or longer a meaningless metric, I am certain there are many neurosurgeons, neuro-oncologists, and GBM patients who will not agree with you.

The diagnosis of GBM offers an extremely and consistently poor prognosis (as you know), and there is a myriad of very qualified KOLs that seem to think the regulatory agencies are willing to consider this ECT comparison. And that is ultimately what counts, and not what simply doesn’t comport for you in particular.

[sukus]

This video from BMY on Immunotherapy can help clarify AVII's concerns.

.

The evidence of the long tails at the end of the trial and the OS stats at 5 year could help determine who the real winner is. IMO.

Median OS cannot really be used for comparisons per what the video above stipulated.