Yeah this is an interesting case, though I don't know why...

Yeah this is an interesting case, though I don't know why you are bringing it up here.

Ojjaara met the primary endpoint of spleen volume reduction for all patients in that trial.

Met the primary endpoint.

But failed to be non-inferior to Jakafi with regards to symptomatology.

Now a secondary endpoint was reached - a reduction in transfusion requirements. And this was explained by a specific theoretical mechanism.

Which was great - as a number of studies have shown that morbidity and mortality is independently increased with the number of transfusions one receives while in hospital.

So they looked at the subgroup of patients who had anaemia in the study - and this subgroup not only met the primary endpoint of being non-inferior to Jakafi (spleen volume reduction) it was actually significantly better than Jakafi.



So, if your post was to compare MSB to Ojjaara, the key take always is:

1) Ojjaara met the primary endpoint with their study
2) The mechanism makes sense
3) The subgroup analysis was to evaluate a subpopulation that Ojjaara may actually be better as a first line agent than the leading therapy Jakafi, based on findings from the secondary endpoint success.

Totally different situation than MSB, who simply failed their primary endpoints, had some findings in some subgroup analysis that don't really fit to a proposed mechanism, and now need to go back and prove that wasn't a statistical anomaly.

Which is why MSB is not having success with their subgroup trawling