RE:RE:RE:RE:ONCY Presented Positive GOBLET Pancreatic Cancer Data @ ESMOIn contrast to ONCYs adaptive, randomized, biomarker and surroate endpoint focused goblet clinical trial ... Seagen gained an Accelerated Approval on their MOUNTAINEER trial that was primarily a randomized and biomarker (RAS wild-type, HER2-positive) / surrogate endpoint (ORR, PFS) directed ... so the need for a few more patients in their trial likely was a decision made collectively by the investigator, the CRO, the sponsor, and the FDA (i.e the stakeholders).
A global, randomized phase 3 clinical trial (MOUNTAINEER-03) is ongoing and will compare TUKYSA in combination with trastuzumab and mFOLFOX6 with standard of care, which is intended to serve as a confirmatory trial and potentially support future global regulatory submissions.