RE: SCIB16 Sep 2023 17:08
Burble,
Thanks for the reply.
Yes, you may well have hit the nail on the head and the difference is that the update due is for 15 Keytruda only patients and the remaining 28 will be on doublet therapy, but then Lindy Durrant also confirmed in the RNS of 10th July that the results due in Q3 include those on doublet therapy so it's a bit of a mystery.
This is from the latest TD note:-
'Top-line data from the first stage (Cohort 1) of the SCOPE study, examining SCIB1 in combination with doublet therapy, are expected during Q423. This cohort will recruit up to 15 patients ........'
'The second stage will recruit up to a further 28 patients (for a total of up to 43 patients across both stages).................Recruitment is expected to be complete by the end of 2023 with data around three months later'
So that reads that stage 2 with 28 patients is an expansion of cohort 1?
Regarding overall patient numbers, the RNS of 10th July was very careful in its wording, ie. '73% of the required number of patients' . I'm not sure how the trial is powered but required number and planned number might be 2 different figures and as you alluded to in your post, they might refer to different patient populations. Worth noting that originally the trial was due to recruit 44 patients and so the difference between the 43 referred to by TD and the 87 on clinicaltrials.gov might be accounted for by another iSCIB1+ arm?
I guess all will become clear when the AACR-CIMT posters are published which no doubt will include a summary of the trial design.
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