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.