NorthWest Biotherapeutics Inc (NWBO)

[jondoeuk]

The DCVax-Direct study was a Phase I, single-arm, dose-escalation trial. It was not intended to demonstrate tumor shrinkage. Its goals were safety, feasibility, and identification of immune activity. This is standard for Phase I trials in immunotherapy.

It was a Phase I/II (N=60) trial. The only objective measure of efficacy used was response rate (i.e., tumour shrinkage). Tumour response was assessed using both RECIST and irRC. So the trial was a failure from an efficacy perspective.

Many of these patients had stable disease at 8 weeks.

You mean to tell me that fast-growing tumours are worse than slow-growing ones?! Does anyone else know about this?! I suggest you tell the medical community asap!

Several were still alive at the time of data cutoff. Their survival durations were not marginal. They were multiple years in cases where a few months would have been expected.

There was no SOC and no control arm. Without a control arm, there is no way to objectively assess survival (PFS and/or OS).

These were not patients with easy-to-treat disease. They were heavily pretreated, end-stage cancer patients with no systemic therapy in the trial.

Twenty (51.3% of those enrolled) had under two or fewer prior therapies.

The trial generated survival outliers and immune biomarkers in line with modern immunotherapy understanding.

Using NWBO's own data https://www.thestreet.com/investing/stocks/biotech-school-how-to-spot-hidden-danger-signs-in-clinical-trial-data-13748701

And now that foundation is being advanced.

What foundation? It had no single-agent activity. Drugs with no single-agent activity rarely, if ever improve outcomes in randomised and controlled trials (when used in combination).