MSB 1.02% 99.0¢ mesoblast limited

You said: "I read the itacitinib trial out of interest and noted...

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    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:

    OutcomesAge at inclusionUsed with steroids
    1Remestemcel trial (NCT02336230)Clinically meaningful (Yes)
    Statistically significant (Yes)
    2 months to 17 yearsNo (participant has failed first-line steroid treatment)
    2Itacitinib trial (NCT03139604Clinically meaningful (?)
    Statistically significant (No)
    18 years and olderYes



    https://hotcopper.com.au/data/attachments/4580/4580890-2706ef9db9770ccb148c8417accb40f4.jpg

    https://hotcopper.com.au/data/attachments/4581/4581266-4faec9ef722bbddc687d34797d3b75c1.jpg

 
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