Progress in trial results since 5 AprilWhile the total treated patient population has remained stable, the latest MD&A contains a few interesting nuggets of new information as compared to the trial update of 5 April.
First, response rates are now (finally) calculated as a percentage of evaluable patients, and thus give a much more accurate picture of the achievements so far.
Second, whereas the update of 5 April suggested that 4 patients of the undertreated cohort received an optimized maintenance treatment and hence from 180 days became part of the optimized cohort (which started with 23 patients treated at 90 days and continued with 27 patients from 180 days on), in the MD&A the suggestion is that only 2 patients are considered to have qualified for that transition (optimized patients treated goes from 23 at 90 days to 25 at 180 days onward).
Third, as the combined result of this reshuffle (2 patients removed from optimized, but not from the study), and what would seem to be some additional evaluation data having become available since 5 April, we now have:
- For the whole population (38 patients): 1 more evaluable patient (EP) at 90, 270, 360 and 450 days, and 3 more EPs at 180 days, resulting in 2 more CRs at 180 days, and 1 more NR at 90 through 450 days.
- For the optimized cohort (23/25 patients): 1 more EP at 180 days and 1 EP fewer at 270, 360 and 450 days, resulting in 1 CR less at 90 days, 3 CRs more at 180 days, 1 NR more at 90 days, and 1 NR less at 180, 270, 360 and 450 days.
In result, the optimized cohort now more clearly outperforms the undertreated cohort at 90, 180 and 270 days (but not yet at 360 and 450 days), and we have 2 more CRs stacked up at 180 days who may continue to demonstrate that CR further along the line.
Nothing all too shocking, but moving in the right direction imo. GLA.