Long ago SRX told everyone they could only release a limited amount of info cos that was the stipulation of ASCO. If they present more then they cannot present at ASCO ( biggest opportunity to speak to oncologists around the world).
I agree regarding comments regarding PFS. It seemed it was destined to fail as comparing SRX and chemo with chemo alone means that any tumour progression ( primary, hepatic, secondary outside liver) will result in s strike and be noted as progression free faillure. With 60% of the group having extra hepatic metastases then there is a big group of patients who have tumours outside the scope of Sir spheres
Why did they pick PFS? Well a large proportion of oncology papers use PFS because you can get results earlier . There is a lot of debate about whether it should be used as a surrogate for OS but in the interest of faster analysis ( I'm not justifying this) they often look at PFS especially when comparing systemic treatments such as chemotherapy. My understanding is that this was a consideration when this trial was set up back in 2006 (longtime ago) and most likely to influence oncologists. The reason its not statistically significant seems no surprise. in my opinion, does not spell end for SRX as first line as many people have said.
Why could it still be first line?
!. OS has not been reported yet. This will be reported together with the FOXFIRE trial . Its part of the reason that PFS was picked as primary end point. To get a faster result. So we need to wait tip 2017 to see OS!! The four other trials have OS as primary endpoints ( inc SARAH etc looking a primary HCC)
2. Liver shown to be statistically significant impact. Whether this influences OS or not, for the use of a single shot of sir spheres, shown to have low systemic toxicity , and cost low compared to months of chemo.. and to control liver symptoms could still be an adjunct.
What else is coming up?
Primary HCC and its use in other tumours has not even been touched yet. trials yet to complete so have to wait.
Theres been steady growth for 42 quarters
Great management. A lot of people bagging them but they CANT say anything else. Their release and the amount they have said is what they have said they could only release all along until ASCO. No surprises.
Even if not first line still has large scope for growth!
Could it be a failure?
Yes. Risk reward my friends. Betting against 42 quarters an growth and UMPTEEN number of articles showing benefit of SIR spheres.
But yes could still happen.
Could show toxicity.. causing deaths or severe morbidity.
Could show minor liver significance only
Could show NO change in OS which would turn off oncologists ( who are the gatekeeper and from which referrals come from).. Remember oncologists have to refer to radiation oncologists to make this happen. In the political world of medicine . that means many oncologists will want to see statistically significant results they can hang their hat on before ceding control of their patients. ( probably rightly so)
My opinion?
Im buying.
I think its an unfortunate ( perhaps fortunate buying opportunity) combination of an announcement that showed a primary end point was not met but could not be qualified due to the stipulation of ASCO. The company have announced a secondary end point that liver PFS is stat significant. They have also hinted that liver failure is what causes most people to die with MCC. The spheres work.
Seems like quite few funds ( UBS etc) would agree having become substantials, as well as Hall and Montgomery buying back again
Like a lot of things I am probably wrong. But Im a buyer down here. Please don't buy on this rant but thought I would just share my thoughts. DYOR
SRX Price at posting:
$21.50 Sentiment: Buy Disclosure: Held
(20min delay)