Second-line treatment with pembrolizumab significantly improved overall survival compared with chemotherapy among patients with advanced urothelial carcinoma who received first-line platinum-based chemotherapy, according to a study presented at the European Cancer Congress (ECCO) 2017.1
The open-label, phase 3 KEYNOTE-045 trial (ClinicalTrials.gov Identifier: NCT02256436) enrolled 270 patients with recurrent or progressive metastatic urothelial carcinoma regardless of PD-L1 expression. The patients were randomly assigned 1:1 to receive intravenous pembrolizumab every 3 weeks for 24 months or investigator’s choice of paclitaxel, docetaxel, or vinflunine every 3 weeks.
Results showed that pembrolizumab therapy reduced the risk of death by about 28% compared with investigator’s choice of chemotherapy (hazard ratio [HR], 0.723; 95% CI, 0.59-0.91; P < .0022). Median overall survival with pembrolizumab was 10.3 months (95% CI, 8.0-11.8) vs 7.4 months (95% CI, 6.1-8.3) with chemotherapy; the 1-year overall survival rates were 43.9% and 30.7%, respectively.
More than 20% of pembrolizumab-treated patients achieved a confirmed objective response, including complete responses in 7%.
There was, however, no statistically significant difference in progression-free survival between the 2 treatment arms (HR, 0.98; 95% CI, 0.81-1.19; P = .42).
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Pembrolizumab was also associated with fewer any-grade and grade 3 to 4 treatment-related adverse events. The most common treatment-related adverse events in the pembrolizumab arm were pruritus, fatigue, nausea, and diarrhea.
Four patients in each arm died from treatment.
- Necchi A, Bellmunt J, de Wit R, et al. Pembrolizumab vs investigator-choice chemotherapy for previously treated advanced urothelial cancer: phase 3 KEYNOTE-045 study. Paper presented at: European Cancer Congress 2017; January 27-30, 2017; Amsterdam, Netherlands.