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atezolizumab plus bevacizumab (n=336) vs. sorafenib (n=165)
randomized controlled trial
atezolizumab-bevacizumab
atezolizumab–bevacizumab group received 1200 mg of atezolizumab plus 15 mg per kilogram of body weight of bevacizumab intravenously every 3 weeks
sorafenib
400 mg of sorafenib orally twice daily
Dose modifications were not permitted in the atezolizumab–bevacizumab group but were allowed in the sorafenib group.
mHCC - 1st line (L1)
open design
111 sites in 17 countries
P3/two sided One analysis of PFS, two interim analyses, and a final analysis of OS. Repartition, reallocation and hierarchy OS PFS and ORR (arm A then arm B)
In patients with unresectable hepatocellular carcinoma, atezolizumab combined with bevacizumab resulted in better overall and progressionfree survival outcomes than sorafenib
nivolumab alone (n=371) vs. sorafenib (n=372)
randomized controlled trial
nivolumab
NIVO 240 mg IV Q2W
sorafenib
Sorafenib (400 mg oral BID).
mHCC - 1st line (L1)
open label
at medical centres in 22 countries and territories in Asia, Australasia, Europe, and North America
P3 / OS at 2-sided at 0.05 with one IA (at 0.024) and one final analysis (at 0.043). Hierarchical testing: OS > ORR > PFS
this study did not meet its primary endpoint OS
pembrolizumab plus lenvatinib (n=-9) vs. lenvatinib (n=-9)
randomized controlled trial
lenvatinib in combination with pembrolizumab
Lenvatinib
mHCC - 1st line (L1)
study Misses Primary End Points
sintilimab (n=380) vs. sorafenib (n=191)
randomized controlled trial
Sintilimab plus IBI305 (bevaciumab biosimilar)
200mg of sintilimab intravenously over 60min, followed by 15mg/kg body weight of IBI305 bevacizumab biosimilar intravenously over 90min (the second infusion over 60min, and afterwards over 30min if no infusion reaction occurred), every 3 weeks
Sorafenib
400mg orally twice a day
mHCC - 1st line (L1)
open label
China
P3 / two sided alpha = 0.05. First test of PFS at alpha = 0.002, if PFS is statistically significant, the test of the OS would be at alpha = 0.05. If PFS is not statistically significant, the test of the OS would be done with alpha at 0.048.
pembrolizumab alone (n=278) vs. placebo (n=135)
randomized controlled trial
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.
pembrolizumab based treatment (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
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