would there be grounds for early termination? technically
would there be grounds for early termination? technically yes. but its complicated!
imo ORR as the primary is the smartest way to achieve that outcome. its a smart and typical choice for a p2 for many reasons. most importantly you wanna get good data and move to p3 asap. waiting around on OS makes no sense.
whether a dsmb would actually recommend early termination in such a small p2 is complicated, even if the SOC is 6-8& ORR and leronlimab shows 30% or more.
even when they observe groundbreaking results early in a trial, dsmb might be hesitant for several reasons. the basics are that you want as much data as possible to make sure approval is likely. they don;t want to recommend stoppage and then have the fda ask for additional enrollment upon a BLA application. and they want to know as much as possible about not only ORR but also PFS and DOR, even if those aren;t defined endpoints. this is their opportunity to observe all of that.
timing / enrollment also comes into play in a small trial like this...
in order for a patient to be counted towards ORR, you need 2 scans showing a certain shrinkage and continuation of the trend. by the time you get lets say 30 patients with 8 and 12 week scans with 50% being marked towards ORR, you are now 12 weeks beyond enrolling patient 30. you might have enrolled 50 or even all 60 by now. and 30-40 are coming up to their 2nd scans. might as well wait at that point in order to have both more robust datasets towards approval and also a clearer picture of the ultimate ORR as well as a truer statistical significance attached to that ORR. maybe they consider stopping after 12 week scans for all 60 patients are completed.
any early termination would save time. lets call it "up to one year". lets say they need at the very least 40 enrolled and scanned twice thru week 12 to recommend early termination. that's a may 2026 stoppage vs a june 2027 (best guess) end date otherwise.
that would cut 1 year off the timeline to the absolute best case for accelerated approval.
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