ASCO presentations to be released on 22nd May , here’s hoping for a late breaker ,potentially in the much awaited OBD,APAIC trial.
We know that the OBD trial phase has been fully recruited for quite some time now ,58 patients,,we also know that the initial data released some time back showed a 100% DCR, including 1 complete response,2 partial responses and 3 stable disease.The (cr) patient was diagnosed with (TNBC) in 2019,and had failed multiple lines of therapy.This patient if in fact still in cr ,after now 5 plus years could potentially be technically termed as cured,as 5 plus years is needed to realise the cured terminology,this would be amazing for her and her loved ones.
We also know that around 83% of the patients in the trial had a greater then 1.4 fold change in cxcl10 levels after just one 90mg dose of EFTI.CXC10 improves the movement of cells such as T cells,towards the site of inflammation which in turn can aid in the reduction of tumour growth.
In saying this we also know that there were some tolerability issues with this increased dose, and that the company plans to use the very safe 30 mg dose ,in the upcoming trials.Never the less this 90mg data released should prove to be very interesting.
We also know that the 90 mg increase in EFTI was requested by the FDA ,so they could understand the entire scope of EFTIs tolerability, before potentially allowing the company to file for a BLA.
IF my understanding is correct the companies quickest route to market is currently in head in and neck patients ,with a negative pdl1 status.The company states this accounts for approximately 20% of the head and neck market ,whilst analysts such as Wilson’s suggest that is a very conservative figure and the actual market may be as much as double that,make of that what you will.
We have recently been told that the company has immediate plans to meet with the FDA and discuss the path forward in this indication .I have been informed by management that all possibilities will be considered including (priority review )in bringing EFTI to market for these patients.
It is purely my belief only, that the meeting the company has planned with the FDA is a pre BLA meeting.
It is my understanding that the company in this meeting will be informed and guided by,to whether or not they are in fact in a position to electronically lodge for a BLA.
It also is just my understanding that should the company be in position to lodge a BLA application that within the initial 14 days of lodging the BLA ,the company will be informed whether it has been accepted for priority review status ,this entire application window or process if you like is 60 days.
Once again it is just my take that if the company is in fact awarded priority review status,which is awarded by demonstrating better safety and efficacy then current standard of care, that the company after ,this period will then be ,provided they receive priority review a PFDUA date(prescription drug user fee act) of 6 months from this time ,if no priority review is received this PFDUA date is 10 months.
The above is purely my take on things,DYOR
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