Ann: IMU Meets Endpoints in Phase 1b Gastric Cancer Trial, page-87

Looking at the trial on ClinicalTrials.gov it says number of participants is 18, yet on the recent announcement it is 14. Why do these numbers not tally? Trials are supposed to be updated to reflect changes in key criteria, even in October the trial was reporting trial numbers as 18. I may have missed an update in regards to trial numbers earlier, but it appears from comments here another 4 were added more recently to the trial so are not evaluable in this announcement. I wonder when/if we will here any reports on the most recent 4, perhaps in a more detailed summary of the phase1b? To be honest, the number of patients in the trial and what happened to them is murky at this point and that is not confidence inducing.

The word that concerns me is "best"  in the following sentence - "in particular the five patients whose best response showed more than 30% decrease intheir tumour size from baseline scans". We know from the outcome measures quoted in the trial description that tumour size was to be evaluated beyond the 56 days during long term maintenance. Given the first cohort started treatment in August last year they have at least  nine months of meaningful data on tumour size post treatment. I read the "best" as that was as good as it got and the tumours have increased since.

It would have been nice if the phase1/b had produced a clear cut better than standard treatment result that could have been presented without ambiguity. But no Christmas presents this year.

It will be sometime till we have clarity, I have no option other than to wait it out and hope.