@jy201506@flippyfloppy52 I don’t see Ami-Zia had the issue to get approved in full aged patients. The >65 group was even worse - it did not help the patients at all
@Water46333865@adamfeuerstein@matthewherper Check the approved MARIPOSA trial. Age>65 even crossed 1. Always cautious to draw any conclusion from a post hoc, unpowered subgroup analysis!
@UhdeChristopher@WBVALUE@JacobPlieth MARIPOSA interim OS did not hit, HR 0.80 (0.61-1.05). In a trial, you hit interim, you are the king. I don’t get it since when this becomes a flaw.
As a biostat, I can find a tons of trials with non -sig subgroups, including US subgroup crossed the 1.0 line but FDA approved.
@UhdeChristopher@WBVALUE@JacobPlieth To see largely consistent efficacy across so many subgroups, but it is often normal to see a few subgroups look worse. When u observe this, it’s cautious to generalize any conclusion, and if you want to confirm further you run a pre-specified trial