36 (of 43) Recruited in the SCIB1 Cohort Must be Sufficient to Show Necessary ORR24 Sep 2024 18:56
The RNS states “Full cohort data with SCIB1 and iSCIB1+ expected in Q4 2024 and H1 2025, respectively.”
Looking at the SCIB1 Cohort, 36 (out of 43) have been recruited. We know that Scancell will give us data on this cohort in Q4 24. The end of Q4 (31 December’24) is exactly 14 weeks from today.
However, we also know that a patient’s first scan is at 13 weeks after their first dose. There is therefore no realistic time to recruit, dose and scan the remaining 7 patients (43 minus 36) in this cohort.
I suspect that not all of the 36 recruited have yet had their first scan. The only conclusion I can come to is that Scancell believe that the data already received from those of the 36 that have been scanned (and possibly data anticipated from those of the 36 soon to be scanned) will be sufficient to show the necessary ORR. The RNS (AIMHO) backs this up stating “Following completion of the SCIB1 recruitment, the remaining patients with the SCIB1 HLA haplotype will be recruited to test the efficacy of iSCIB1+ in the entire patient population.”
This is the full paragraph:-
“Both the SCIB1 and iSCIB1+ cohorts are in the second stage of the study recruiting a total of 43 patients each with a study design able to demonstrate that SCIB1 or iSCIB1+, in combination with doublet therapy, exceeds currently reported ORRs with doublet CPI alone, in a statistically significant manner. There are currently 36 and 27 patients recruited in the SCIB1 and iSCIB1+ cohorts respectively. Following completion of the SCIB1 recruitment, the remaining patients with the SCIB1 HLA haplotype will be recruited to test the efficacy of iSCIB1+ in the entire patient population.”
(Unfortunately I have not been able to access the webcast yet so haven’t heard what Lindy said).