durvalumab alone (n=240) vs. Standard of Care (SoC) (n=249)
randomized controlled trial
durvalumab
durvalumab 10 mg/kg IV every 2 weeks (Q2W)
investigator’s choice: cetuximab, taxane, methotrexate, or fluoropyrimidine-based regimen
Each SoC agent (cetuximab (35.7%),docetaxel (10.8%), paclitaxel (36.9%), methotrexate (14.5%), Fluoropyrimidine regimen: (2.0%) [5-fluorouracil, TS-1, or capecitabine] was dosed and administered according to local regulations
3 arms: durvalumab, durvalumab plus tremelimumab, SOC
mHNSCC - L2 - all population
open-label
156 sites
P3 / two-sided test procedure with one interim analysis. Alpha splitting between coprimary endpoint and recycling strategy with OS (PDL1 TC<25 in DT)
There were no statistically significant differences in OS for durvalumab or durvalumab plus tremelimumab versus SoC in pts with R/M HNSCC