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durvalumab plus tremelimumab (n=247) vs. Standard of Care (SoC) (n=249)
randomized controlled trial
durvalumab plus tremelimumab
durvalumab plus tremelimumab (Durvalumab 20 mg/kg IV Q4W and Tremelimumab 1 mg/kg IV Q4W for 4 doses, then Durvalumab 10 mg/kg IV 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
durvalumab plus tremelimumab (n=133) vs. durvalumab alone (n=67)
randomized controlled trial
durvalumab plus tremelimumab
durvalumab (20 mg/kg every 4 weeks) plus tremelimumab (1 mg/kg every 4 weeks) for 4 cycles, followed by durvalumab (10 mg/kg every 2 weeks)
durvalumab monotherapy
durvalumab (10 mg/kg every 2 weeks) monotherapy
mHNSCC - L2 - PDL1 negative
PD-L1–low/negative disease
open-label
127 sites in north america, europe, and asia pacific
P2 / no formal statistical plan to evaluate comparison between groups. No formal statistical comparison were planned
Treatment with durvalumab monotherapy and durvalumab tremelimumab resulted in clinical benefit in patients with PD-L1–low/negative tumor cell expression, but no significant difference in efficacy
durvalumab plus tremelimumab (n=133) vs. tremelimumab (n=67)
randomized controlled trial
durvalumab plus tremelimumab
durvalumab (20 mg/kg every 4 weeks) tremelimumab (1 mg/kg every 4 weeks) for 4 cycles, followed by durvalumab (10 mg/kg every 2 weeks)
tremelimumab monotherapy
tremelimumab (10 mg/kg every 4 weeks for 7 doses then every 12 weeks for 2 doses) monotherapy.
mHNSCC - L2 - PDL1 negative
PD-L1–low/negative disease
open-label
127 sites in north america, europe, and asia pacific
P2: no statistic plan to evaluate comparison between groups. No formal statistical comparison were planned
Treatment with durvalumab monotherapy and durvalumab tremelimumab resulted in clinical benefit in patients with PD-L1–low/negative tumor cell expression, but no significant difference in efficacy
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