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Wednesday, February 19, 2014 12:40:01 PM
You said:
at the end of the trial they (IMUC) had data that said they improved PFS by 2 months and it was not yet stat sig. I could be wrong but i believe that was the case.
Actually, PFS was found to be statistically significant. And when the favored protocol was used in 117 out of 124 patients, those 117 had 3 months extended survival over s.o.c. with a p-value of 0.0074.
And that is with only 6 synthetic antigens.
A comparison of PFS between ICT-107 and placebo showed a statistically significant difference in the Kaplan-Meier (K-M) curves favoring ICT-107 (p=0.014 two-sided, hazard ratio (HR)=0.56) in the intent-to-treat population of all 124 randomized patients. The difference in the median progression-free survival times between ICT-107 and placebo favored ICT-107 and was two months in duration. For the per-protocol population (117 of 124 patients receiving at least four induction vaccinations), the K-M comparison p-value improved in treated patients to 0.0074 two-sided (HR=0.53) and the difference in median progression-free survival times increased to three months in favor of ICT-107.
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