FDA approves Keytruda to treat Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ, - Merck Inc.

Merck Inc., announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy 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. “High-risk, non-muscle invasive bladder cancer is a serious disease, characterized by frequent recurrences and progression,” said Arjun V. Balar, M.D., associate professor of Medicine and director of Genitourinary Medical Oncology at NYU Langone Health’s Perlmutter Cancer Center. “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.” The approval was based on data from KEYNOTE-057 (NCT02625961), a multicenter, open-label, single-arm trial in 96 patients with 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. In that single-arm trial, Keytruda completely cleared signs of cancer in 41% of 96 participants who had BCG-unresponsive carcinoma in situ after three months. Among the 39 patients who reached a complete response, 18 remained cancer-free for a year or longer, as the median duration of response lasted 16.2 months after a median follow-up of 28 months. Comment:The new indication adds to Keytruda’s existing two bladder cancer approvals, both in more advanced metastatic disease in which the tumor has already penetrated the muscle layer of the bladder.