What is the role of pembrolizumab (Keytruda) in the treatment of metastatic bladder cancer?

Updated: Feb 23, 2021
  • Author: Kara N Babaian, MD, FACS; Chief Editor: Bradley Fields Schwartz, DO, FACS  more...
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Pembrolizumab (Keytruda) gained approval from the FDA for urothelial carcinoma in May 2017. It is indicated for locally advanced or metastatic urothelial carcinoma in patients who are not eligible for cisplatin-containing chemotherapy. It is also indicated for patients with disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Approval was based on the KEYNOTE-052 trial. As first-line treatment for patients who were ineligible to receive platinum-based chemotherapy, the ORR was 24% at the time of initial phase II data evaluation. [139]

Pembrolizumab is the only drug with data from a phase III trial demonstrating overall survival benefit vs chemotherapy in the second-line setting for metastatic bladder cancer, with an overall response rate of 15-20% in an unselected patient population. [80]  The FDA approval for second-line therapy for advanced urothelial carcinoma was based on an international phase III trial (n=542). ORR was 10.3 months in the pembrolizumab recipients compared with 7.4 months in the chemotherapy group. [140]

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