Since it’s first line, participants can’t have received any other treatment?

This announcement brings up memories of two other drugs that were in the PanCan.org Precision Promise Trial Platform as phase III candidates a few years ago. The first one was CPI-613 (Devimistat) by Raphael Pharmaceutical. It was looking very promising in the phase II portion of its trial. It received fast-track status and the Biopharmaceutical company began making plans to bring it to market by hiring executives, support staff for ramping up production and distribution. But when the data was evaluated, it showed no better performance than existing standard of care to which it was compared. What was different between the phase II and phase III portions of the trials? In a phase II trial, the inclusion/exclusion criteria is skewed to accepting healthier patients. Phase III trials are more “real world” accepting patients that are more I’ll with the disease. When the data of the phase III cohort was compared to the control group receiving standard of care, there was no significant difference and in some patients, a slightly worse outcome resulted.

In another Precision Promise trial testing the small molecule drug SM-88 (Racemytyrosine) from Tyme Pharmaceutical, it too looked very promising. The same scenario of no statistical difference was demonstrated in the phase III trial after phase II results looked so promising.