The Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab; Merck) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
The approval was based on data from the KEYNOTE-057, an open-label, single-arm trial that enrolled 148 patients of which 96 had BCG-unresponsive high-risk non-muscle invasive bladder cancer. Patients received Keytruda 200mg every 3 weeks until unacceptable toxicity, persistent or recurrent high-risk non-muscle invasive bladder cancer, or progressive disease. Major efficacy outcome measures included complete response (as defined by negative results for cystoscopy, urine cytology, and computed tomography urography imaging) and duration of response.
After a median follow-up of 28.0 months, results showed a complete response rate of 41% (95% CI, 31-51) and median response duration of 16.2 months (0.0+, 30.4+); 46% of responding patients experienced a complete response lasting ≥12 months.
Commenting on the approval, Arjun V. Balar, MD, associate professor of Medicine and director of Genitourinary Medical Oncology at NYU Langone Health’s Perlmutter Cancer Center, said, “Historically, patients with high-risk, non-muscle invasive bladder cancer with CIS whose cancer is unresponsive to BCG treatment had limited non-surgical treatment options. As a physician who specializes in the management of bladder cancer, it is encouraging to now have a new treatment option for these patients.”
Keytruda, a programmed death receptor-1 (PD-1)-blocking antibody, is also indicated for the treatment of small cell lung cancer, non-small cell lung cancer, melanoma, head and neck squamous cell cancer, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, endometrial cancer, hepatocellular carcinoma, merkel cell carcinoma, and renal cell carcinoma.
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