RE:RE:RE:RE:RE:RE:ONCY's Bracelet-1 was in HR+/HER2 negative breast cancerOnce again the major determinant of clinical benefit for the FDA is overall survival (OS) which was statistically significantly improved in both of ONCY's IND-213 and Bracelet-1 mBC Phase 2 clinical trials with a near doubling of OS between the treatment and control arms of pelareorep (monotherapy) + paclitaxel vs paclitaxel alone, respectively.
The 38.2% improvement of PFS in ONCY's Phase 2 Bracelet-1 mBC clinical trial is a positive surrogate endpoint that drives long-term overall survival (OS) which demonstrated a near 2X improvement, and is the reason why the FDA had agreed that PFS be the primary endpoint in ONCY's 180-200 patient Phase2b->Phase3->Confirmatory trial and overall survival (OS) trhe secondary endpoint. It couldn't be much clearer and the reason why pelareorep is on the near-term Accelerated Approval pathway.