pembrolizumab alone (n=307) vs. Standard of Care (SoC) (n=352)
randomized controlled trial
pembrolizumab
pembrolizumab 200 mg every 3 weeks (Q3W) for a maximum of 35 cycles
chemotherapy alone (cisplatine or carbo plus gemcitabine)
Investigator’s choice of cisplatin 44% [70 mg/m2 Q3W] plus gemcitabine [1000 mg/m2 on days 1 and 8 Q3W] OR carboplatin 56% [AUC 5Q3W] plus gemcitabine if cisplatin ineligible)
3 arms: pembrolizumab ± chemotherapy versus chemotherapy Dose modifications for pembrolizumab were not permitted;
mUC - L1 - all population
open label
201 medical centres in 21 countries
A Bonferroni approachwas used to control the type I error rate at α=0·025(one-sided), with 0·005 allocated to progressionfree survival and 0·02 allocated to overall survival.A sequential testing strategy was used
Results from the trial indicated that the PD-1 inhibitor plus chemotherapy failed to result in a statistically significant improvement in progression-free survival (PFS) or overall survival (OS) over chemotherapy in patients with treatment-naïve advanced urothelial carcinoma