pembrolizumab
200 mg of pembrolizumab intravenously every 3 weeks for at least 35 cycles(approximately 2 years).
placebo
saline placebo intravenously every 3 weeks for at least 35 cycles(approximately 2 years).
Both arms received BSC at the discretion of the investigator in accordance with local practices
mHCC - 2nd line (L2)
double blind
119 medical centers in 27 countries
P3/ one sided Two interim efficacy analyses and a final efficacy analysis of O. Repartition and hierarchy with OS and PFS
In this study, OS and PFS did not reach statistical significance per specified criteria.
KEYNOTE-394, 2022 NCT03062358
pembrolizumab alone (n=300) vs. placebo (n=153)
randomized controlled trial
pembrolizumab
pembrolizumab: 200mg Q3W for ≤35 cycles
placebo
placebo: Q3W for ≤35 cycles
best supportive care
mHCC - 2nd line (L2)
double blind
P3 / P value boundary for OS superiority at final analysis (FA) was 0.019307. If OS was superior, PFS and ORR superiority at the second interim analysis (IA2; primary analysis timepoint for these endpoints) could be tested at boundaries of 0.013447 and 0.009139, respectively
Pembro plus BSC significantly improved OS, PFS, and ORR compared with placebo plus BSC as second-line therapy for patients from Asia with advanced HCC