Yes, Bio, I did qualify what I said in the same post.
And on reflection, I'll drop my reference to second line, and I agree with yourself and with Ex that it should most accurately be described as a first line adjuvant therapy.
Clearly, upon approval, NWBO would expect to achieve Level 1 status(the highest) in the NCCN guidelines, for the whole (resectionable) GBM population and then you are 90% of the way to being adopted as established SOC.
And then it can be named the Stupp/Liau protocol. (Or Liau/Stupp if you prefer..)
Though if approval was limited to meth, then my comments would only apply to meth. But if the delta is there in unmeth, then there is no reason to think that approval would be restricted by subgroup. After all, Chemorad has been there for over a decade as SOC for both meth and unmeth, though it is now widely accepted that TMZ offers minimal benefit to unmeth.
God knows why, but Optune has now also achieved Level 1 status in NCCN. But I think it couldn't really be described as SOC.
It has the feel of a more elective option, which some patients will use but others will choose not to. But I believe it is now insurance-covered in the US, because it is Level 1.
Though in some European countries, such as the UK, although approved, it cannot be prescribed within the Public Health set-up.
NICE appears to accept that Optune offers a mean life extension of 3-4 months, but no more than that. And therefore discludes it as a drug that the NHS should provide, due to the unacceptable cost/benefit ratio.
So not available on the NHS (and probably never will be), but likely available privately.
I've long held the view that DCVax-L will be able to pass a NICE economic evaluation in due course. (Though NICE pretty well always achieves an undisclosed price discount from the nominal 'list price' of any expensive cancer therapy.)
And, at least to some extent, NICE sets the tone for much of the rest of Europe, I believe.
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