Avid Bioservices Inc (CDMO)

[bimerkjaere]

Interestingly, Peregrine has added language around OS in the prostate cancer. They now will be continually reviewing OS throughout the trial (see below). This supports the continued belief that OS is vital for determining bavi efficacy. Also note that primary endpoint has changed from overall PFS to the probability of PFS.

From clinicaltrials.gov:

Overall survival [ Time Frame: 24+ weeks ] [ Designated as safety issue: Yes ]
To estimate the overall survival in subjects with CRPC (previously treated with docetaxel) following cabazitaxel + bavituximab therapy. Overall survival will be assessed continually during the duration of the study.


The primary objective of this study is to determine the probability of progression-free survival (PFS) after 12 weeks of therapy in subjects with CRPC treated with cabazitaxel + bavituximab.