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.
ATTRACTION-2 (Kang), 2017 NCT02267343
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.
KEYNOTE-061 (all population), 2018 NCT02370498
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.