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avelumab alone (n=185) vs. Standard of Care (SoC) (n=186)
randomized controlled trial
avelumab
avelumab 10 mg/kg by intravenous infusion every 2 weeks
physician's choice of chemotherapy (paclitaxel or irinotecan)
physician's choice of chemotherapy (paclitaxel 80 mg/m2 on days 1, 8, and 15 or irinotecan 150 mg/m2 on days 1 and 15, each of a 4-week treatment cycle); patients ineligible for chemotherapy received best supportive care. 120 (64.5%) patients received irinotecan, 54 (29.0%) paclitaxel, and 3 patients (1.6%) received BSC only.
Subjects receiving physician’s choice plus BSC will not be offered to cross over to avelumab plus BSC.
mGC or mGEJC - L2 - all population
Notably, 93 patients (25.1%) were enrolled in Asian countries.
open-label
147 sites in North America, South America, Asia, Australia, and Europe
P3 / one sided and one Interim analysis. Hierarchy OS then PFS then ORR
Treatment of patients with GC/GEJC with single-agent avelumab in the third-line setting did not result in an improvement in OS or PFS compared with chemotherapy at this primary analysis.
Ipilimumab (10 mg/kg) (n=57) vs. Standard of Care (SoC) (n=57)
randomized controlled trial
ipilimumab
ipilimumab 10 mg/kg, every 3 weeks for four doses during the induction phase and then 10 mg/kg every 12 weeks for up to 3 years during the maintenance phase
SoC (maintenance)
either continuation of first-line fluoropyrimidine chemotherapy as maintenance or BSC maintenance treatment.
Crossover between treatment arms was not allowed.
mGC or mGEJC - L2 - all population
previous irradiation of the measurable lesion was not allowed.
open label
12 countries across Asia, Europe, and North America
P2/two sided and one interim analysis. Only irPFS (a=0.2) !! 20%
Although ipilimumab at 10 mg/kg was manageable, it did not improve irPFS versus BSC
nivolumab alone (n=330) vs. placebo (n=163)
randomized controlled trial
nivolumab
nivolumab at 3 mg/kg every 2 weeks
placebo
placebo every 2 weeks
mGC or mGEJC - L2 - all population
double blind
49 clinical sites in japan, south korea, and taiwan,
p3 / one sided and one interim analysis. No plan found
results suggest an improvement of OS and PFS but no specific statistical plan was found to validate this results.
pembrolizumab alone (n=296) vs. paclitaxel (n=296)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg intravenously every 3 weeks
paclitaxel
paclitaxel 80 mg/m2 intravenously on days 1, 8, and 15 of 4week cycles
Patients in the paclitaxel group were not permitted to cross over to receive pembrolizumab.
mGC or mGEJC - L2 - all population
open label
148 medical centres in 30 countries
P3/ one sided and one interim analysis. Repartition OS/PFS and hierachy PDL1 et pop tot
Pembrolizumab did not significantly improve overall survival compared with paclitaxel as second-line therapy for advanced gastric or gastro-oesophageal junction cancer with PD-L1 CPS of 1 or higher.
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