(UroToday.com) Immune checkpoint blockade therapy by blocking PD-1/PD-L1 axis signaling is approved in advanced urothelial cancers in a few settings: (1) first-line therapy for platinum-ineligible patients, (2) first-line therapy in cisplatin-ineligible patients with high PD-L1 expression, (3) maintenance therapy for patients who do not progress with first-line chemotherapy, and (4) as subsequent therapy for patients progressing after cisplatin-based first-line therapy. Approvals for settings #1 and #2 is based on single-arm phase 2 data, with setting #3 based on the JAVELIN-100 Bladder randomized control trial. Durvalumab, an anti-PD-L1 antibody, is one of the immunotherapy agents approved for setting #4.
