RE:RE:RE:RE:RE:ONCY's Bracelet-1 was in HR+/HER2 negative breast cancerONCY has demonstrated that PFS was 38.2% better in the pelareorep + paclitaxel treatment arm of Bracelet-1 vs the control arm of paclitaxel alone and reproduced a near doubling (2X) median overal survival seen in IND-213 - which is the clinical benefit that the FDA is seeking.
Consequently ONCY's 180-200 patient Phasew2b->Phase3->Confirmatory trial will have PFS as the primary endpoint, which in turn will drive Accelerated Approval, with overall survival (OS) as the secondary endpoint.
IND-213 trial, treatment with pelareorep in combination with paclitaxel led to a statistically significant near doubling of overall survival in patients with HR+/HER2- metastatic breast cancer in a randomized setting.
The PFS demonstrated in Bracelet-1 is supported by trhe statistically near boubling of the overall survival seen in both IND-213 and in the Bracelet-1 Phase 2 trials.
And as you Quentin30 already posted citing Satoshi Kato and Shunsuke Ono, of the laboratory of pharmaceutical regulatory science at The University of Tokyo --- " A majority of accelerated approvals were granted from a single trial (76%) and non-comparative single or multi-arm trials (79%) where response rate was the primary or secondary endpoint (94%)." .. meanwhile ONCY had a a near doubling in the clinical benefit of OS --- further supporting ONCY's Bracelet-1 results as the basis for an Accelerated approval.