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Checkpoint inhibitors have shown activity in patients with metastatic bladder cancer in both the second-line setting and the first-line setting (before chemotherapy), explained Andrea B. D., who heads the Bladder Cancer Section in NCI’s Center for Cancer Research’s (CCR) Genitourinary Malignancies Branch.

“But we still need—and are awaiting—the results of ongoing randomized trials comparing checkpoint inhibitors and chemotherapy in the first-line setting for patients with metastatic bladder cancer,” she continued.

The Food and Drug Administration (FDA) in recent weeks has approved four immunotherapy drugs for bladder cancer, bringing the total number of approved immunotherapies for this disease to five.

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In this multicenter, randomized clinical trial, pembrolizumab was associated with an improvement in median overall survival (of approximately 3 months) and with a lower rate of treatment-related adverse events than chemotherapy as second-line therapy.

The accelerated approval of pembrolizumab as a first-line therapy for bladder cancer was based on results from the KEYNOTE-052 study, a single-arm, open-label trial in 370 patients with locally advanced or metastatic bladder cancer who were not eligible for cisplatin-containing chemotherapy.

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