Replies to post #214996 on NorthWest Biotherapeutics Inc (NWBO)

[iclight]

In this trial, per the protocol, this is how progressionnis defined. So every 2 months or during an unscheduled MRI they will determine if progression happened and document it as a progression event.

14.2. DEFINITION OF PROGRESSION AFTER ENROLLMENT
Progression, calculated from the nadir tumor burden (i.e. post operative, Baseline, or
Baseline 2), is defined as one of the following:
• In the case of complete resection during primary therapy: a new measurable tumor
at the site of the resected tumor, defined as a mass with a longest diameter equal to
or greater than 1 cm in at least one dimension. If progression is not defined by these
studies, treatment may proceed and determinations made at the next scheduled
MRI.
• In the case of incomplete resection during primary therapy: a 25% increase or
greater in the residual tumor if the recurrent portion of the tumor is at least 1 cm or
greater in its longest diameter, measured by MRI and confirmed by scans above as
attributable to tumor growth;
• If resection is indicated for recurrent disease, while radiographic criteria for
progression have not been met: surgical resection, subsequently confirmed as
progressive GBM by Pathology at the clinical site and to be confirmed by
independent pathology;
• Appearance of any new lesion/site at least 1 cm in at least one dimension or greater
measured by MRI and confirmed by scans above;
• Unequivocal progression of non-measurable disease (either non-enhancing disease
seen only on T2/FLAIR images or enhancing disease not meeting size criteria for
measurability), such that there is confidence that tumor growth has occurred;4
• Death: all deaths are counted as events for the primary endpoint.
Radiographic evidence of disease progression will be evaluated and corroborated by
independent radiology review to determine disease progression for purpose of this trial.
MRIs to assess disease progression are done every 2 months. Unscheduled MRIs or
other testing will be recorded in eCRFs. If, during unscheduled procedures, there is
evidence of disease progression, it must be confirmed through independent review as
described above.

[AVII77]

It was more in the sense of cross-over.

Quote:
Almost 90% of patients have received DCVax-L at some point. -67% received it at randomization, and the rest received DCVax-L after documented disease progression.

Wait and see???

Yes, now there is talk of looking at the documentation for those patients and coming up with a new criteria.

If retrospectively applied equally to both arms that may work in the absence of x-over.

But the patient already crossed years ago.

So, what do you do if you have a SOC patient who progressed, crossed over and received dcvax, and then it turns out the tumor regressed (psPD).

Was that regression due to DCVax on x-over or due to psPD from SOC (we know SOC causes psPD, we don't know if DCVax causes psPD).

How do you handle that? You can't suck the dcvax out of him.

Havoc.