Ann: IMU Meets Endpoints in Phase 1b Gastric Cancer Trial, page-67

Gekko

The trial was dose limiting and they dose 3 patients at a given level to see if there are any toxicity issues that could be attributed to the trial drug. If there are no issues, they move onto the next higher dose and repeat.  This can slow things up as they need to wait for each lot of 3 patients to complete before they can evaluate and move onto the next dose.  The P2 doesn't have these wait and evaluate breaks, so it should move along at a reasonable clip(please).  If there are issues at a particular dose, they would have expanded to 6 patients at that level and evaluated before moving on to the next higher dose. 

Given there were no safety issues, the core of the trial could have been completed with 9 patients, although I don't know if they added extras for patients that didn't complete treatment long enough to be evaluable - day 56 according to footnote 3 in the announcement.  People are saying there are 4 extra patients still to present data, but I haven't seen a statement that says this is so.  Patients that failed to complete treatment to day 56 would not be evaluable, but could still make up the 14 count.  It's unclear.  I hope that the 10 evaluable  patients made up the core group and that we still have info to come for 4 extras, it could really put a shine on the results if they all showed up as PR.

Obvious question, they didn't reach a dosage that was limited by toxicity.  I wonder if the immune response was levelling off or whether it looks like there was headroom for increased dosage and immune response?

cheers