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longfellow95

08/03/18 6:12 AM

#184990 RE: Lykiri #184950

Lykiri.
You are of course quite right that Optune is not available on the NHS currently. Though I have heard that NICE will be undertaking an STA on Optune in due course. And I have previously commented that NICE may end up doing STA's on both at more or less the same time.

I guess what I was getting at, is the need for DCVax to demonstrate its superiority over Optune, otherwise DCVax might fail to gain approval in the US. And then US patients will have to go with Optune.

Optune did put up an exceptionally good set of figures, though they had over 30% with MGMT status either 'invalid' or 'unknown.'
How they got away with that I don't know.
Optune also now has a Cat 1 recommendation in the NCCN guidelines.

A lot of the early datapoints like OS12 and OS24 and even mOS are looking to be very close between them, but the long tail is where DCVax will demonstrate superiority, if the trial continues long enough to collect that data.

Optune doesn't have the long tail characteristic of immunotherapies, though its data right up to 5yr survival is still good on paper.

So that, in a nutshell, is why NWBO need to continue the trial for a further few months. To better demonstrate survival at 3yrs and longer. If NWBO don't take their best data set to the FDA, they are likely to fail.