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cemiplimab (n=356) vs. Standard of Care (SoC) (n=354)
randomized controlled trial
cemiplimab
cemiplimab 350 mg administered intravenously over aperiod of 30 min every 3 weeks (for up to 108 weeks[ie, up to 36 treatment cycles]) Cemiplimab dose modification was not allowed
ICC
four to six cycles ofinvestigator’s choice of platinum-doublet chemotherapy (n=128 paclitaxel plus carboplatin102 pemetrexed plus carboplatin39 pemetrexed plus cisplatin37 gemcitabine plus carboplatin37 gemcitabine plus cisplatin11 paclitaxel plus cisplatin) 74% crossed over to cemiplimab
Crossover from chemotherapy tocemiplimab was allowed following disease progression
mNSCLC - L1 - all population
Patients were ineligible if they had never smoked
open label
138 clinics in 24 countries
P3/ two sided and 5 interim analysis. To control type 1 error, two sided alpha 0.05 split between the analyses of overall survival (0·04)and progression-free survival (0·01). The α allocated to progression-free survival was subject to reallocation to overall survival, provided the progression-free survival analysis was positive, and vice versa.The key secondary endpoint of objective response rate was tested hierarchically when both analyses of overall survival and progression-free survival were significant
Cemiplimab monotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in patients with advanced non-small-cell lung cancer with PD-L1 of at least 50%,providing a potential new treatment option for this patient population.
cemiplimab (n=283) vs. Standard of Care (SoC) (n=280)
randomized controlled trial
cemiplimab
cemiplimab 350 mg administered intravenously over aperiod of 30 min every 3 weeks (for up to 108 weeks[ie, up to 36 treatment cycles]) Cemiplimab dose modification was not allowed
ICC
four to six cycles ofinvestigator’s choice of platinum-doublet chemotherapy (n=128 paclitaxel plus carboplatin102 pemetrexed plus carboplatin39 pemetrexed plus cisplatin37 gemcitabine plus carboplatin37 gemcitabine plus cisplatin11 paclitaxel plus cisplatin) 74% crossed over to cemiplimab
Crossover from chemotherapy tocemiplimab was allowed following disease progression
mNSCLC - L1 - PDL1 positive
Patients were ineligible if they had never smoked
open label
138 clinics in 24 countries
P3/ two sided and 5 interim analysis. To control type 1 error, two sided alpha 0.05 split between the analyses of overall survival (0·04)and progression-free survival (0·01). The α allocated to progression-free survival was subject to reallocation tooverall survival, provided the progression-free survival analysis was positive, and vice versa. The key secondary endpoint of objective response rate was tested hierarchically when both analyses of overall survival and progression-free survival were significant
Cemiplimab monotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in patients with advanced non-small-cell lung cancer with PD-L1 of at least 50%,providing a potential new treatment option for this patient population.
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