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.