RE: SCIB111 Oct 2022 11:11
Good to see something on the SCIB1 trial, but I can infer some positives and negatives from the video.
The trial design slide shows that there is a 35 day analysis for the first cohort then a 25 week analysis on cohort two, before expanding into Simon Stage 2.
We know the first patient in trial arm 2 (SCIB1 and Pembrolizumab) was dosed in November 2021, so we can possibly assume that the assessment periods for the initial cohort of patients has been completed - but that is assuming they managed to recruit enough patients to hit the cohort numbers, which is not necessarily true given that standard treatment evolved in that time.
Arm 1 on the slide (scib1, nivolumab and ippilumab) was only approved in June of this year, so at best we can only be part way through cohort 2 with quite a few weeks before we can expand into Simon Stage 2 of this arm. This is the disappointment for me - just how far we are STILL away from completion of this study after all these years (originally scheduled to END in 2018!)
The main positive take away though is that (assuming the pembrolizumab arm has now expanded to Simon Stage 2) they have seen enough of a clinical response in the earlier cohorts to progress into the later phases. This is further backed up by the increase in number of trial sites. Given that the purpose of a Simon Style study is to give you off ramps where the patients aren't responding in sufficient quantity, and we haven't seemingly taken those off ramps, then this bodes well for the success of the trial to date. AIMHO