RE:RE:PanCan's Precision Promise adaptive clinical trial programPrecision Promise is focused around providing an adaptive clinical trial program to accelerate new treatment options in pancreatic patients.
https://pancan.org/research/precision-promise
The Precision Promise study has a primary endpoint of overall survival and can include multiple investigational treatments as well as control arms evaluating: (1) gemcitabine plus nab-paclitaxel or (2) mFOLFIRINOX.
This design, which was developed with guidance from the U.S. Food and Drug Administration, minimizes the number of participants needed to generate licensure-enabling data, thereby accelerating late-stage development by up to two years and reducing costs compared to non-platform trials.
With the intent of accelerating late-stage development of pelareorep in the treatment of 1L metastatic pancrestic cancer, and with a Phase 2 GOBLET-1 pancreatic cancer cohort that mimics the Phase 3, results being reported at ESMO in 2 weeks should set up the Phase 3 study for an Accelerated Approval, with Big Pharma participation through the acquisition of ONCY.