A randomised, open-label, international, Phase 3 comparator trial in patients with previously-treated locally advanced urothelial cancer.²

KEYNOTE-045 is a randomised open-label, international Phase 3 comparator trial enrolling 542 patients with locally advanced or metastatic, previously-treated urothelial cancer. Investigator-choice chemotherapy were either; Paclitaxel 175 mg/m², Q3W, Docetaxel 75 mg/m², Q3W or Vinflunine 320 mg/m², Q3W). Overall Survival and Progression-Free Survival were co-primary endpoints in the total and PD-L1 combined positive score ≥ 10 population.²

Co-primary endpoints consisted of overall survival and progression free survival in the total and PD-L1 combined score ≥ 10 populations. Overall survival is defined as the time from randomisation to death from any cause. Progression-free survival was defined as the time from randomisation to disease progression or death from any cause. Secondary endpoints consisted of objective response rates, defined as the percentage of patients who had a confirmed complete or partial response, and the duration of confirmed response, defined as the time from the first documented complete or partial response to disease progression or death.²

The results of this phase 3 trial, were first published with a median follow-up of 14.1 months on February 17, 2017, at NEJM.org.² The latest data cut off is presented - median duration of follow-up was 62.9 months (58.6-70.9 months). Data cut off was 1 October 2020.³

Median OS in the total population - 10.3 months (HR = 0.73, 95% CI, 0.59-0.91) p = 0.002
Median PFS in the total population - 2.1 months (HR = 0.98, 95% CI, 0.81-1.19) p = 0.416 (NS)

Median OS in the PD-L1 combined positive score ≥10; 8 months (HR = 0.57, 95% CI, 0.37-0.88) p = 0.005
Median PFS in the PD-L1 combined positive score ≥10 (HR = 0.89, 95% CI, 0.61-1.28) p = 0.24 (NS)