Abstract
In the field of systemic therapy for metastatic urothelial cancer, more than 30 years has passed without the development of any definitive subsequent-line of therapy for patients who do not respond to platinum-based combination chemotherapy. However, immune checkpoint inhibitors, such as pembrolizumab, have built a solid evidence base for a role as a second-line therapy for patients with platinum-refractory metastatic urothelial cancer. The pivotal phase 3 trial, KEYNOTE-045,1 evaluating the survival benefit of pembrolizumab in 542 patients with platinum-refractory metastatic urothelial cancer, showed that median overall survival in the pembrolizumab group was 10·3 months (95% CI 8·0–11·8), which was significantly longer than that in paclitaxel, docetaxel, or vinflunine chemotherapy group (7·4 months [6·1–8·3]).
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