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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
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
nivolumab alone (n=240) vs. Standard of Care (SoC) (n=121)
randomized controlled trial
nivolumab
nivolumab at a dose of 3 mg per kilogram of body weight) every 2 weeks
ICC (methotrexate, docetaxel or cetuximab)
weekly intravenous administration of methotrexate (38.0%) at a dose of 40 to 60 mg/m2, docetaxel (43.0%)at 30 to 40 mg/m2, or cetuximab (10.7%)at 250 mg/m2 after a loading dose of 400 mg/m2
Dose modifications were not permitted for nivolumab but were specified for methotrexate, docetaxel, and cetuximab on the basis of the type and grade of the toxic effect.
mHNSCC - L2 - all population
an age of at least 18 years; an Eastern Cooperative Oncology Group performance-status score of 0 or 1
open-label
66 sites in 15 countries in North America, Asia, Europe, and South America
P3 / two-sided test procedure with one interim analysis. Hierarchical testing procedure for secondary endpoints PFS and ORR
Among patients with platinum-refractory, recurrent squamous-cell carcinoma of the head and neck, treatment with nivolumab resulted in longer overall survival than treatment with standard, single-agent therapy
pembrolizumab alone (n=247) vs. Standard of Care (SoC) (n=248)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg every 3 weeks intravenously
chemotherapy (methotrexate, docetaxel or cetuximab)
standard treatment per week (methotrexate, docetaxel or cetuximab) methotrexate (26.2%) 40 mg/m2 intravenously (could be increased to 60 mg/m2), docetaxel (44.4%)75 mg/m2 every 3 weeks intravenously, or cetuximab (29.4%) 250 mg/m2
There was no planned crossover on disease progression.
mHNSCC - L2 - all population
open-label
97 medical centres in 20 countries.
P3/ one-sided test procedure with two interim analysis. Hierarchy and split between secondary endpoints : one sided 0.025
pembrolizumab provides a clinically meaningful overall survival benefit compared with investigator’s choice of methotrexate, docetaxel, or cetuximab in patients with recurrent or metastatic head- and-neck squamous cell carcinoma that progressed during or after platinum-based therapy (in all population and CPS>1)
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
pembrolizumab alone (n=196) vs. Standard of Care (SoC) (n=191)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg every 3 weeks intravenously
chemotherapy (methotrexate, docetaxel or cetuximab)
standard treatment per week (methotrexate, docetaxel or cetuximab) methotrexate (26.2%) 40 mg/m2 intravenously (could be increased to 60 mg/m2), docetaxel (44.4%)75 mg/m2 every 3 weeks intravenously, or cetuximab (29.4%) 250 mg/m2 (% for ITT population)
There was no planned crossover on disease progression.
mHNSCC - L2 - PDL1 positive
open-label
97 medical centres in 20 countries.
P3/ one-sided test procedure with two interim analysis. Hierarchy and split between secondary endpoints : one sided 0.025
pembrolizumab provides a clinically meaningful overall survival benefit compared with investigator’s choice of methotrexate, docetaxel, or cetuximab in patients with recurrent or metastatic head- and-neck squamous cell carcinoma that progressed during or after platinum-based therapy (in all population and CPS>1)
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