Jun. 18 at 12:20 AM
$CMPX
Beyond the OS miss, the data package has several elements that work in Compass’s favor for an accelerated approval argument.
The primary endpoint itself is strong: ORR of 17.1% vs 5.3% (p=0.031), confirmed by blinded independent central review, more than tripling the response rate seen with paclitaxel alone. Disease control rate also came in solidly favorable at 61.3% vs 36.8% (p=0.0027), and PFS showed a striking effect size — HR 0.44, p<0.0001, a 56% reduction in progression risk. The trial design itself is a structural advantage too: it’s randomized with BICR confirmation, which is actually a higher evidentiary bar than the single-arm studies that supported prior BTC accelerated approvals like pemigatinib, futibatinib, and ivosidenib.
