RE:RE:RE:? for the board
What is nice about having a confirmed biomarker is that after the observation period of what ever they decide in the trial protocols have been done and patient assessed they then decide if that patient will continue on with treatment as they would be most likely to respond and the patients that did not pass the benchmark would then be removed from the trial and not be considered evaluable so as not to skew the overall trial endpoints. The end result greatly increases the odds of success in the phase 3 trial depending upon the trial endpoints.
ONC stated in the pr that they will be incorporating this into the trial protocols.
From the PR
“Taken together, these translational data affirm pelareorep’s ability to enhance T cell infiltration into tumors and expand TILs in the peripheral blood, which have been correlated with tumor response. We intend to incorporate these learnings into the designs of our registrational studies in metastatic breast cancer and pancreatic cancer.”