RE:PanCan's Precision Promise adaptive clinical trial programPanCan's Precision Promise clinical trial program is focused around providing an adaptive clinical trial program to accelerate new treatment options in pancreatic patients.
https://pancan.org/research/precision-promise/
ONCY's June 22, 2023 announcement that PanCan has selected ONCY's pelareorep for a Phase 3 clinical trial program, will serve to support approval of pelareorep in combination with atezolizumab + gemitibine + nab-paclitaxel in first line metastatic pancreatic cancer.
https://www.prnewswire.com/news-releases/oncolytics-biotechs-pelareorep-selected-for-inclusion-in-precision-promisesm-pivotal-phase-3-platform-trial-301857678.html
Data presented at SITC 2022 showed a near tripling of overall response rate for pelareorep + gemcitabine + nab-paclitaxel + a PD-L1 inhibitor compared to historical control trials
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.