RE: For 'Techies' . . . . . .12 Jan 2024 10:18
Goodmorning TF, thanks for posting is a really interesting article.
My take is the following, the current 13 SCOPE patients stand out as they have no new lesions ( and this alone makes the difference) but as yet this is not statically significant to prior studies using CPI alone.. we need data on >20 .
Quote from the article....
"Nevertheless, note that in current SCOPE data, the number of paƟents is small. Consequently, if we compare the prevalence of new lesions in the 13 paƟents in SCOPE (0/13, assuming the single
paƟent with PD also did not present new lesions) to the prevalence of new lesions in the 53 paƟents
in Wolchok et al (13/53, 25%), the difference is not staƟsƟcally significant at p < 0.01 by chi-square
or, the more appropriate due to sample size, Fisher’s exact test (p = 0.046 and 0.056, respecƟvely).
Even If we pool Wolchock and Shoushtari (cauƟon: a different populaƟon) data together, p-values
are 0.02 and 0.03 for Chi-square and Fisher’s, respecƟvely. We would need data on about 18-20
paƟents to reach significance at p < 0.01, assuming the current trend conƟnues.
During the AGM, the CEO indicated that, to date, 21 paƟents are under treatment in SCOPE study. If
the current trend of ORR in absence of new lesions conƟnues, before the end of Q1 2024 the
prevalence of new lesions in SCOPE study will be staƟsƟcally significant vs historical controls. "
So we should hopefully get a clear statistical picture by this Q1 🤞 that Scib is superior.
In the article the author gives his timetable...I note the author feels partnering will be in Q2 this year if all is well 🤞
"Q1 2024: ORR data on 20+ paƟents with SCIB1, if trend conƟnues this will be the first study were no
paƟents under treatment developed new lesions, resulƟng in excellent ORR sustained over a
meaningful period of Ɵme (expected median around 4-5 months). In addiƟon, SCIB1 cohort is fully recruited. iSCIB1+ starts recruiƟng towards the end of Q1.
Q2 2024: 6 month PFS data for 18-20 paƟents, 12 month PFS/OS data for 5 paƟents and addiƟonal 3month ORR data for about 10 paƟents (SCIB1), at this point it is likely that SCIB plaƞorm for
melanoma will be partnered assuming current trend conƟnues. PreparaƟon to iniƟate phase 2/3
blinded, controlled, adapƟve registraƟonal trial is announced.
Q3 2024: By mid Q3, we should have solid ORR data on iSCIB1+ (assuming they recruit at least 10
paƟents per month from end of Q1 2024)."
I would urge all to read the article as it covers afew scenarios.
Hopefully by Q2 I may get my 50 pence ...and a drink with TF 😀