Hi
@Wilba32,
yes, the REACH-4 study is a real worry IMO.
It's undoubtedly being used by Novartis to bridge its way into the pediatric SR-aGVHD market globally. But the 'study' (I'm not going to call it a trial) is a horrific joke, as I see it.
Have a look at this:
Yep. They kept the kids on corticosteroids all the way through - how's that for a confounder!! Oh, but you say their attending physicians in trial NCT03774082 (REACH-4) would have monitored CS tapering & done it properly to differentiate efficacy, right?
Attending physicians...hmmm. What a quaint concept.
Check this out as an 'independent', 'multi-center' study - this is BigPharma in action - and it pays to remember that this is what Mesoblast is up against:
Now what, pray tell, is a
NOVARTIS INVESTIGATIVE SITE? And why are we looking at sites in the Russian Federation, or India, or Brazil?
Note also that this 'treatment' has a drug code -
INC424. Guess what the INC stands for. If you think Incyte, you wont be too far wrong. And that means, IMO that these study 'results' are planned to be used by Incyte in the united States of America. If they're not handing them out already.
So, what's the big dea? Read this & tell me what you think:
So, it looks to me as if Novartis Pharmaceuticals in pushing Ruxolitinib on children is going to hang its hat on 28 day ORR & not OS (or even PFS) in a situation in which corticosteroids are still being employed as standard of care. It seems Novartis has no qualms about calling its study a superiority study despite it being a single-arm open label study. And
56 days makes for a
DURABLE response. How convenient.
The apparent arrogance & contempt for proper trial data management is quite staggering, IMO.
To fail to provide
ANY morbidity and mortality data, much less
3-4 year morbidity and mortality data, despite the study commencing in
2018 is inexcusable.
And the failure to explain to the world exactly what the 'safety profile of RUX' is, also hides a dismal prognosis of AEs, as I see it. I have read too many Ruxolitinib papers which do not wish to list the contraindications for Ruxolitinib, or do not wish to list the Ruxolitinib AEs or even the SAEs in the paper, so they use a copout line like:
" ...
The safety profile of RUX was also consistent with that expected for RUX in this population. "
Wow. Expected by whom? Novartis? Incyte? Or was it expected by the patients?
This 'study' was designed by Novartis, at sites hand-picked by Novartis, sites 100% controlled by Novartis, staffed & run by Novartis, with attending physicians and clinicians employed by Novartis.
I would love to understand how those 'impartial' investigators decide that a patient's treatment was "discontinued due to lack of efficacy" when the poor patient was, on another view, in decline and likely to die or approaching death. It is a terrible thing to suggest, but could those 'researchers' in the Russian Federation or elsewhere possibly have decided that was a good time to cease the Ruxolitinib treatment? And censor the data?
This is a terrible study as I read it. It has marketing & greed written all over it, as I see it.
This is what RYONCIL is up against.
Cheers,
GLTA(LT)H
(20min delay)