The FDA has approved pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)–unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.1
The approval is based on findings from the phase II KEYNOTE-057 trial (NCT02625961), in which the PD-1 inhibitor elicited a complete response (CR) rate of 41% (95% CI, 31%-51%) in 96 patients with high-risk NMIBC with CIS with or without papillary tumors; the median duration of response (DOR) was 16.2 months (0.0+, 30.4+). Additionally, 46% of responding patients experienced a CR lasting ≥12 months.
"For patients with high-risk, non-muscle invasive bladder cancer that has become unresponsive to BCG treatment, the most effective treatment option is a radical cystectomy, which includes removing the entire bladder and a prostatectomy for men or total hysterectomy in women," lead KEYNOTE-057 study author Arjun V. Balar, MD, associate professor of medicine and director of Genitourinary Medical Oncology at NYU Langone Health's Perlmutter Cancer Center, said in a statement. "This surgery carries a substantial risk for morbidity and mortality and can negatively impact quality of life. In fact, many patients are not medically eligible for a radical cystectomy. This approval provides a new approach for treating patients with BCG unresponsive high-risk non-muscle invasive bladder cancer, and moreover highlights the continued impact that systemic immunotherapies have had in the management of this disease."
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