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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.
avelumab alone (n=249) vs. Standard of Care (SoC) (n=250)
randomized controlled trial
avelumab maintenance
avelumab 10 mg/kg administered by intravenous infusionevery 2 weeks as maintenance phase
chemotherapy
continuation of the same chemotherapy regimen from the induction phase
All recruited patients received induction phase 1L therapy with oxaliplatin, leucovorin and 5-fluorouracil (FOLFOX/FLO) or oxaliplatin and capecitabine (XELOX/CAPOX) for 12 weeks
mGC or mGEJC - M - HER2 negative
who had achieved at least stable disease following 12 weeks of first-line oxaliplatin/fluoropyrimidine chemotherapy ECOG > 2
open label
at 200 sites in North America, South America, Asia–Pacific and Europe.
P3 / one sided and one interim analysis. Alpha split between co-primary endpoint (2% OS overall 0.5% PDL1) with recycling strategy and hierarchical testing procedure with PFS then OS if both OS were significant
this study did not meet its primary objective of demonstrating superior overall survival. Avelumab maintenance after chemotherapy for patients with gastric cancer (JAVELIN Gastric 100 study) does not improve overall survival
avelumab alone (n=30) vs. Standard of Care (SoC) (n=24)
randomized controlled trial
avelumab maintenance
avelumab 10 mg/kg administered by intravenous infusionevery 2 weeks as maintenance phase
chemotherapy
continuation of the same chemotherapy regimen from the induction phase
All recruited patients received induction phase 1L therapy with oxaliplatin, leucovorin and 5-fluorouracil (FOLFOX/FLO) or oxaliplatin and capecitabine (XELOX/CAPOX) for 12 weeks
mGC or mGEJC - M - HER2 neg/PDL1 positive
who had achieved at least stable disease following 12 weeks of first-line oxaliplatin/fluoropyrimidine chemotherapy ECOG > 2, PD-L1–positive status was defined as PD-L1 protein expression in > 1% of tumor cells.
open label
at 200 sites in North America, South America, Asia–Pacific and Europe.
P3 / one sided and one interim analysis. Alpha split between co-primary endpoint (2% OS overall 0.5% PDL1) with recycling strategy and hierarchical testing procedure with PFS then OS if both OS were significant
this study did not meet its primary objective of demonstrating superior overall survival. Avelumab maintenance after chemotherapy for patients with gastric cancer (JAVELIN Gastric 100 study) does not improve overall survival
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