Dr. Balar on Rationale for KEYNOTE-057 in NMIBC

Arjun V. Balar, MD, assistant professor, Department of Medicine, director, Genitourinary Medical Oncology Program, NYU Langone’s Perlmutter Cancer Center, discusses the rationale for the KEYNOTE-057 study in patients with non—muscle invasive bladder cancer (NMIBC).

The study, which was presented by Balar at the 2019 Genitourinary Cancers Symposium, aimed to test the efficacy of pembrolizumab (Keytruda) in a specific subset of patients with NMIBC. These were patients with high-risk disease who previously received Bacillus Calmette-Guérin (BCG), an intravesical immunotherapy, and became unresponsive to the treatment.

Historically, these patients would be treated with radical cystectomy—complete surgical removal of the bladder. This was done because with BCG unresponsive disease, the natural history of the disease is to progress toward muscle invasive and, eventually, metastatic disease. Radical cystectomy was felt to be the only curative strategy for these patients. In this setting is where the PD-1 inhibitor pembrolizumab was tested, with the hope that these patients can ultimately preserve their bladders.

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