You said: "I read the itacitinib trial out of interest and noted that both arms reported a survival that was similar to that shown with remestemcel-l although in adults vs paediatrics."
It seems to me from your posts over the last couple of days you are trying to figure out the relative efficacy between Rem-L and itacitinib for aGVHD. IMO this can not be done in any meaningful way.
The main reason is very different patient characteristics and when treatment is started ('apples to oranges'):
The Remestemcel-L Pivotal Study 001 (NCT02336230) was tested in paediatric patients who failed to respond to steroid treatment for aGVHD. In other words Rem-L was trialed for SR-aGVHD paediatric patients.
On the other hand, the 'failed' GRAVITAS-301 (NCT03139604) trial of the JAK1 inhibitor itacitinib was treated in adult GVHD patients in combination with steroids. This trial did not find a statistical significant result between the treatment group (itacitinib + corticosteroids) versus the comparator group (placebo + corticosteroids). In laymans terms, it may have been the corticosteroids that were doing the heavy lifting. Having said this, to be fair to itacitinib, there was a trend to improved outcomes but this was not found to be statistically significant (also a big question mark if this trend in improved outcomes was clinically meaningful?).
So in short for aGVHD:
Outcomes Age at inclusion Used with steroids 1 Remestemcel trial (NCT02336230) Clinically meaningful (Yes)
Statistically significant (Yes)2 months to 17 years No (participant has failed first-line steroid treatment) 2 Itacitinib trial (NCT03139604 Clinically meaningful (?)
Statistically significant (No)18 years and older Yes
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