I guess Sawston is being readied to meet demand, before Accelerated Approval is applied for.
No point in applying for AA until you have unequivocal evidence of efficacy and assured manufacturing capacity.
Obvious surrogate endpoint is tumor shrinkage/eradication based on MRI images. This might be 6-9 months after reactive inflammatory response (pseudo progression) with treatment arm. And perhaps 12 months after a placebo subject crosses over.
Tumor regression/eradication, decrease in tumor load would be reliable indicators of objective response and stable disease.
Such a surrogate endpoint would have to be clearly evident in a sufficient number of trial subjects, to make any other explanation virtually statistically impossible!
So, I guess it might be a few months yet, but in the scheme of things that's not long.
NWBO might also be actively pursuing an application to the MHRA for approval in the UK and the rest of the EU, which is something we tend to forget.
Oh yes, pseudo progression is an indicator of much enhanced median OS in GBM. One study recorded median OS of 34.7 months for pseudo progressors compared to 13.4 months for patients without pseudo progression!
This was on SOC, not immunotherapy. And, if you had MGMT promoter methylation status as well as pseudo-progression, median OS jumped to 54.1 months...
Much more effective than a certain other device touted on here!
Extract from this study.
Quote:-
Title
"Diagnosis of Pseudoprogression using MRI perfusion in patients with Glioblastoma Multiforme may predict improved survival."
Gahramanov et al.
"Aims
This retrospective study determined the survival of glioblastoma patients with or without pseudoprogression.
Methods
A total of 68 patients were included. Overall survival was compared between patients showing pseudoprogression (in most cases diagnosed using perfusion MRI with ferumoxytol) and in patients without pseudoprogession. MGMT methylation status was also analyzed in the pseudoprogression cases.
Results
Median survival in 24 (35.3%) patients with pseudoprogression was 34.7 months (95% CI: 20.3–54.1), and 13.4 months (95% CI: 11.1–19.5) in 44 (64.7%) patients without pseudoprogression (p < 0.0001). The longest survival was a median of 54.1 months in patients with combination of pseudoprogression and (MGMT) promoter methylation.
Conclusion
Pseudoprogression is associated with better outcome, especially if concurring with MGMT promoter methylation. Patients never diagnosed with pseudoprogression had poor survival. This study emphasizes the importance of differentiating tumor progression and pseudoprogression using perfusion MRI."
