Curious to keep this conversation going as SOC was the very thing that the crew was talking about in terms of informing trial design for the adult sR-aGvHD.
One thing I took away from the conference call that Tanushree Jain (BP Analyst) asked was on precisely that - whether they would be opting for a superiority trial or a non-inferiority trial, where the SOC would be used as the comparator.
Some light weekend reading assigned by Mr James :
Comparisons of Superiority, Non-inferiority, and Equivalence Trials
"There is no accepted standard-of-care treatment for SR-aGVHD [11, 34]. This is due to most studies in SR-aGVHD being retrospective, single-arm, phase 2 studies [8, 11, 35], which cannot be easily compared with current patient populations due to significant changes in not only supportive care but also prophylaxis of GVHD. In addition, there are a lack of standardized endpoints, small numbers of enrolled patients, and decreased survival rates, making it difficult to compare data across studies [6, 8]." [source: here]
If you read between the lines, should the Prof and his crew pursue a superiority trial against the current SOC for adult sR-aGvHD (which they are already deep in planning with the top minds in oncology as mentioned both last night and this morning), one might end up in a situation where ruxo might be booted out as rem-L steps up to the plate out-performing on all fronts. If I was an INCY holder, I'd be quaking right about now if the company hasn't made any plans to refine the DP that's currently being used after the patients become steroid-refractory (the stats are that 35-50% of patients end up like that (source: here).
If there's a ruxo V2.0, I'd love to see it.
@nosluggos, you mentioned - "Whether the difference be significant enough to justify stopping the trial (ie and approving for use) on Covid ARDS patients at the 30% or 45% readouts?"
I wonder what the null hypothesis for the trial... that would be something that would point us to the primary endpoint no?
Thoughts anyone?
MSB Price at posting:
$4.69 Sentiment: Buy Disclosure: Held
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