The 5.5 vs 1.6 data is in the N=85 subgroup who had 1st line immo agents, not the ITT population. This is important because one would expect such to be almost all prior treatment in the future. This should certainly help uptake once approved.
Also, all the listed subgroups were solid on PFS.
ORR came in at 15% vs 7%.
The preliminary OS was trending at an HR of .81, kind of "meh", hopefully this number can improve a bit with age.
Submission next month. Hopefully a fast turn by the FDA might see an approval by about EOY (ok, I know one should never expect such).
Admittedly I do not follow the S Korean drug development scene, but this sounds like a bunch of nonsense.
. The trial closed enrollment a few months ago, and the primary endpoint is +12 months. So early next year for data, and that is what is posted.
. PFS for a single arm trial would not be considered for approval by any legit body. Basic issue is that one can not compare time based data to historical norms, and w/o such there is nothing to go on.
. Changing the N well into an open label trial is more than a minor problem.
Oh, the drug might well be approved over there. But this would say more for Hanmi's family ties than the strength of clinical evidence.