RE:RE:RE:RE:RE:RE:ONCY's Bracelet-1 was in HR+/HER2 negative breast cancerand Matt and Prof Heineken already told us that Bracelet-1 was not powered for statisical significance.
How many patients were in each arm? lets just remind the boys and girls shall we...
Bracelet-1
Cohort-1 (n=15) Pax
Cohort 2 (n=15) Pax + Pela
Primary endpoint for this trial was ORR, which was almost 3 times better than Pax alone.
and exploratory endpoint PFS was better in Pela + Pax vs Pax by 3 months.
but there was no difference in PFS from the IND213 trial, so ONCY has a mixed bag of results again. This explains why the pps is in the wc.
They need the PFS to translate to improved OS, so they can use it as a surrogate end point... they have the OS data now... so they know the answer,. Question is WHY are they stalling?